GLAUCOMA 1, OPEN ANGLE, D (Disorder)NCT07436871
Comparison of Visual Outcomes and Patient Satisfaction in Mild to Moderate Glaucoma Patients Undergoing Cataract Surgery With EDOF Versus Monofocal IOLs
A study testing Cataract surgery (Monofocal intraocular lens implantation) and cataract surgery (Extended depht of focus intraocular lens implantation) in people with GLAUCOMA 1, OPEN ANGLE, D (Disorder) and Cataract, run by OMIQ Research.
Trial summary
Cataract is the leading cause of reversible vision loss, while glaucoma remains the primary cause of irreversible blindness, often impairing contrast sensitivity (CS), glare tolerance, and dark adaptation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GLAUCOMA 1, OPEN ANGLE, D (Disorder), Cataract
- What is being tested?
- Cataract surgery (Monofocal intraocular lens implantation) and cataract surgery (Extended depht of focus intraocular lens implantation)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- 31 Jan 2026to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of any sex aged 18 years or older willing to participate and sign the informed consent form.
- Clinically significant cataracts in both eyes.
- Patients clinically diagnosed of primary open angle glaucoma (POAG) in both eyes.
- Early to moderate POAG, as defined by a mean deviation in the Humphrey Visual Field Analyzer (HFA) no worse than ≤ -12 dB and worse ≥ -2 dB at least in one eye, using a 24-2 SITA standard strategy
- Two visual field tests without progression and stability of RNFL in Optical Coherence Tomography (OCT) thickness remaining same or less than 10 um in the previous 6 months, with pharmacologically controlled IOP in both eyes <21mmHg.
- Potential for post-surgery monocular distance corrected visual acuity of ≤ 0.10 LogMAR.
- Normal corneal topography.
- Able to attend all study visits.
Who cannot join
- Patients with uncontrolled glaucoma, defined as those with an IOP ≥21 mm Hg despite maximal medical therapy, requiring glaucoma surgery and/or laser in either eye in the next year.
- Pre-surgery refractive error requiring IOL implantation beyond the commercially available range.
- Patients with a not reliable visual field, a VFI ≤ 60% or defects of ≤ 10 dB in the 4 central points of the visual field.
- Any other form of glaucoma (pseudoexfoliative, severe forms of pigmentary, primary angle closure glaucoma, etc.), ocular hypertension, zonular instability or possible intuitive lens decentration after surgery.
- Patients with any previous glaucoma surgery or any other ocular surgery that can affect the results, or any ocular surgery in the previous six months.
- Any other ocular pathology that can affect the results.
Show all 9Show fewer
- Use of topic or systemic medication that may affect vision
- Unable to cooperate to obtain consistent testing results.
- Participation in any other trial during or within 30 days of the screening visit.
About this study
Official title: A Randomized Clinical Trial for the Evaluation and Comparison of Visual Results and Patient Satisfaction in Patients With Primary Open-angle Glaucoma After Bilateral Implantation of an Extended Range of Vision Intraocular Lens Compared to a Monofocal Lens.
Cataract is the leading cause of reversible vision loss, while glaucoma remains the primary cause of irreversible blindness, often impairing contrast sensitivity (CS), glare tolerance, and dark adaptation. These visual challenges are particularly relevant when selecting intraocular lenses (IOLs) for glaucoma patients undergoing cataract surgery.
Monofocal IOLs are the safest and most commonly used option for glaucoma patients due to their optical simplicity and low incidence of photic phenomena, though they do not provide spectacle independence for near or intermediate vision. Multifocal IOLs (MFIOLs), while offering greater spectacle independence, are relatively contraindicated in glaucoma due to increased visual disturbances like glare and halos.
Read more
Extended Depth of Focus (EDOF) IOLs offer an intermediate solution, using advanced optics to provide a continuous range of vision and fewer photic disturbances than MFIOLs. EDOF lenses have demonstrated good uncorrected distance and intermediate visual acuity in patients with mild to moderate glaucoma, with promising CS outcomes and high patient satisfaction. However, findings on CS performance remain inconsistent across studies.
Given these considerations, this study seeks to determine whether EDOF IOLs can be a viable alternative to monofocal lenses in glaucoma patients, potentially expanding their options for spectacle independence without compromising visual quality. The trial, conducted at OMIQ (Barcelona), will directly compare an EDOF IOL and a monofocal IOL made from the same material to assess their effects on visual acuity, contrast sensitivity, and photic phenomena in this specific patient population.
Read the detailed description
While cataract is the most prevalent cause of reversible loss of vision, glaucoma remains the leading cause of irreversible blindness, characterized by a progressive optic neuropathy with degeneration of retinal ganglion cells and visual field loss. Glaucoma negatively affects low-luminance contrast sensitivity, glare symptoms, and dark adaptation time more frequently than any other domain. Therefore, when choosing the type of lens to implant in these patients, concerns arise regarding contrast sensitivity (CS) loss and subjective visual disturbances, which may be more debilitating and can also be a limitation when choosing IOLs.
Monofocal IOLs have been shown to be the safest IOL choice for patients with glaucoma. Multifocal IOLs provide spectacle independence but, due to the technology used combined with the pathological changes in glaucoma, tey can cause more visual disturbances, which makes them a relative contraindication in eyes with glaucoma.
Recent studies have demonstrated that EDOF IOLs can be safely be implanted in eyes with mild, pre-perimetric open-angle glaucoma with favourable uncorrected distance and intermediate visual acuity outcomes. Additionally, contrast sensitivity measurements also have been shown to be favourable in this patients and satisfactory spectacle independence and patient satisfaction in the subjective questionnaire.
However, it is yet unknown if EDOF IOLs could be an equal or a better option in patients suffering from cataracts and glaucoma, compared to a Monofocal lens made of the same material, since this could provide wider options when choosing the IOL and could offer spectacle independence for intermediate and distant vision for these patients.
Rationale and positioning with regard to the state-of-the-art Cataract surgery is one of the most performed surgeries worldwide, where the natural lens of the eye is removed and replaced by an artificial intraocular lens (IOL) with the aim of replacing its functions of focusing on objects at different distances. While cataract is the most prevalent cause of reversible loss of vision, glaucoma remains the leading cause of irreversible blindness, characterized by a progressive optic neuropathy with degeneration of retinal ganglion cells and visual field loss. It is estimated that one in five people undergoing cataract surgery have glaucoma or ocular hypertension, with the incidence of both cataract and glaucoma increasing with age.
Glaucoma negatively affects low-luminance contrast sensitivity, glare symptoms, and dark adaptation time and extent. Patients report problems with lighting and dark adaptation more frequently than any other domain. These problems worsen with progressing visual field loss. Some studies have reported that early-stage glaucoma patients experience significantly more difficulties in low-luminance or changing lighting conditions than age-matched controls. Therefore, when choosing the type of lens to implant in these patients, concerns arise regarding contrast sensitivity (CS) loss and subjective visual disturbances such as glares and haloes, which may be more debilitating and may be also a limitation when choosing certain IOLs.
Currently, there are four main groups of IOLs: monofocal, enhanced monofocal, extended depth of focus (EDOF), and multifocal lenses. All of them provide different types of vision with different types of optical technology, which can make the patient to be more or less a candidate to wear them.
Monofocal IOLs provide excellent outcomes for distant vision, with the benefit of generally low cost and low frequency of photic phenomena such as glares and haloes.Therefore, they are the safest IOL choice for patients with pre-existing ocular pathology, like glaucoma, as they do not split light. However, as they only provide one focus point, they fail to deliver spectacle independence for near and intermediate vision.
Compared with traditional monofocal IOLs, premium IOLs, like Multifocal (MF) and Extended Depht-of-Focus (EDOF), offer the benefit of better unaided visual acuity, greater spectacle independence, and higher patient satisfaction.
MFIOLs, come in varying optical designs, such as diffractive, refractive, bifocal, trifocal, or hybrid IOLs, and provide multiple focal points, which allows the patient to see at different distances. However, pathological changes in glaucoma may also potentially interact with the optical effects of MFIOLs, as they tend to cause more halo or glare symptoms due to light scattering at the transitional zone between the distant and near focus of the lens, fact that makes them a relative contraindication in eyes with glaucoma.
EDOF IOLs use a recent technology that creates a single elongated focal point to enhance depth of focus and range of vision, effectively providing satisfactory near and intermediate vision while addressing limitations of MFIOLs, including negative photic phenomena such as glares and haloes. In addition, they also have provided superior intermediate and near vision and a similar visual disturbance profile compared with an aspheric monofocal IOL.
They enhance correction of chromatic aberration and maintain good CS that may be comparable to that of monofocal IOLs. Due to this characteristics, this type of lenses may be an option for glaucoma patients.
EDOF IOLs' behaviour is still not well understood as there have been conflicting results regarding CS outcomes. Certain studies have demonstrated a decrease in CS in eyes with EDOF IOLs under scotopic conditions, compared to eyes with monofocal IOLs while other studies reported no significant difference, and some others reported that EDOF IOLs performed significantly better than trifocal IOLs under both photopic and scotopic conditions. However, new EDOF IOLs have appeared safe and efficacious when implanting it patients with early to moderate bilateral glaucoma, warranting further studies in this population.
Today, choosing a monofocal IOL in patients with glaucoma is the most recommended option and the safest one, given the lack of interference of its optical technology with the optico-pathological changes produced by glaucoma. Most IOLs today use a new type of optical technology that allows the patient to be spectacles independent or independent for near and intermediate vision, which is a great advantage. However, this type of technology is not well tolerated by glaucoma patients, meaning that they have fewer options when choosing an IOL compared to the standard population, that they cannot benefit from this premium technology, and that, therefore, it makes them dependent on glasses for near and intermediate vision. However, despite controversies, EDOF IOLs have proven to be somehow effective in glaucoma patients.This study aims to find out if an EDOF IOL could help to open up a door for these patients, by analysing its behavior compared to a monofocal lens made of the same material and by obtaining the effect of this lens on the visual acuity in at different distances and, additionally, to evaluate the CS and the photopic phenomena like glares and halos.
- Conditions
- GLAUCOMA 1, OPEN ANGLE, D (Disorder), Cataract
- Being tested
- Cataract surgery (Monofocal intraocular lens implantation), cataract surgery (Extended depht of focus intraocular lens implantation)
- Keywords
- cataract surgery, Extended depth of focus intraocular lens, Primary open-angle glaucoma
- Medical subject headings
- Cataract, Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cataract surgery (Monofocal intraocular lens implantation)Procedure or surgery
This intervention consists of bilateral cataract surgery, a microsurgical procedure in which the eye's natural, clouded lens is removed and replaced with an artificial intraocular lens (IOL) to restore clear vision. In this study, patients with early to moderate primary open-angle glaucoma (POAG) will receive either a monofocal or extended depth-of-focus (EDOF) IOL. The surgical technique involves standard phacoemulsification through a small corneal incision, followed by IOL implantation into the capsular bag. What distinguishes this intervention from others is the glaucoma-specific population, with perioperative protocols designed to minimize intraocular pressure fluctuations and preserve optic nerve function. Additionally, both IOLs share the same material and platform, allowing for an isolated comparison of optical design effects.
cataract surgery (Extended depht of focus intraocular lens implantation)Procedure or surgery
This intervention consists of bilateral cataract surgery, a microsurgical procedure in which the eye's natural, clouded lens is removed and replaced with an artificial intraocular lens (IOL) to restore clear vision. In this study, patients with early to moderate primary open-angle glaucoma (POAG) will receive either a monofocal or extended depth-of-focus (EDOF) IOL. The surgical technique involves standard phacoemulsification through a small corneal incision, followed by IOL implantation into the capsular bag. What distinguishes this intervention from others is the glaucoma-specific population, with perioperative protocols designed to minimize intraocular pressure fluctuations and preserve optic nerve function. Additionally, both IOLs share the same material and platform, allowing for an isolated comparison of optical design effects.
| Study group | Role | What they receive |
|---|---|---|
| cataract, glaucoma, monofocal intraocular lens | Active comparator | Bilateral cataract surgery in patients with primary open-angle glaucoma receiving monofocal intraocular lens implantation (n = 37 in this study arm). Receives: Procedure: Cataract surgery (Monofocal intraocular lens implantation) |
| cataract, glaucoma, Extended range of focus intraocular lens | Experimental | Bilateral cataract surgery in patients with primary open-angle glaucoma receiving extended range of focus intraocular lens implantation (n = 37 in this study arm). Receives: Procedure: cataract surgery (Extended depht of focus intraocular lens implantation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binocular distance-corrected intermediate visual acuity (DCIVA)
The comparison of the binocular, distance-corrected intermediate visual acuity (bDCIVA) between groups at month 3.
For the visual acuity assessments in this study, measurements will be expressed using LogMAR (Logarithm of the Minimum Angle of Resolution) units. The LogMAR scale provides a standardized way to quantify visual acuity, with higher values indicating worse vision. The range of LogMAR units typically spans from -0.3 (indicating excellent vision) to +2.0 (indicating severe visual impairment), ensuring a comprehensive evaluation of participants' visual performance.
Measured: 3 months
Secondary outcomes (11)
bUDVA, bUIVA, bUNVA, bDCVA and bDCNVA
The binocular, uncorrected and distance-corrected distance, intermediate (66 cm) and near (40 cm) visual acuities (bUDVA, bUIVA, bUNVA, bDCVA and bDCNVA, respectively) in groups at month 3.
For the visual acuity assessments in this study, measurements will be expressed using LogMAR (Logarithm of the Minimum Angle of Resolution) units. The LogMAR scale provides a standardized way to quantify visual acuity, with higher values indicating worse vision. The range of LogMAR units typically spans from -0.3 (indicating excellent vision) to +2.0 (indicating severe visual impairment), ensuring a comprehensive evaluation of participants' visual performance.
Measured: 3 months
mUDVA, mUIVA, mUNVA, mDCDVA, mDCIVA and mDCNVA
he monocular, uncorrected and corrected distance, intermediate (66 cm) and near (40 cm) visual acuity (mUDVA, mUIVA, mUNVA, mDCDVA, mDCIVA and mDCNVA, respectively) in groups at month 3.
For the visual acuity assessments in this study, measurements will be expressed using LogMAR (Logarithm of the Minimum Angle of Resolution) units. The LogMAR scale provides a standardized way to quantify visual acuity, with higher values indicating worse vision. The range of LogMAR units typically spans from -0.3 (indicating excellent vision) to +2.0 (indicating severe visual impairment), ensuring a comprehensive evaluation of participants' visual performance.
Measured: 3 months
Defocus curve
Defocus curve performance at month 3 The defocus curve typically uses diopters (D) as its unit of measurement. Diopters quantify the optical power of a lens and are used to assess how well a person's vision performs across different focus levels (with a scale that typically ranges from -5.00 D to +2.00 D), indicating the clarity of vision at varying distances.
Measured: 3 months
Mesopic and photopic contrast sensitivity
Distance-corrected binocular contrast sensitivity in photopic and mesopic conditions before the surgery and at month 3.
Contrast sensitivity is typically measured using the logarithm of contrast sensitivity (log CS), with a scale that generally ranges from 0 to 3.0. Values close to 3.0 indicate excellent contrast sensitivity, while values closer to 0 suggest significantly diminished contrast sensitivity. In some tests, results may also be reported as decimal values or percentages, where higher values correspond to a better ability to detect low-contrast stimuli. This comprehensive scale allows for an effective evaluation of a person's visual performance in varying lighting and contrast conditions.
Measured: 3 months
Visual field stability
Change in visual field index (VFI) before the surgery and at month 3.
The Visual Field Index (VFI) is typically measured as a percentage, with a scale ranging from 0% to 100%. A VFI of 100% indicates a full visual field with no loss, while lower percentages represent varying degrees of visual field loss.
Measured: 3 months
OCT stability
Changes in mean central subfield macular and mean peripapillary thickness and sector peripapilar retinal nerve fiber layer and macular ganglion cell layer thickness before the surgery and at month 3.
Optical Coherence Tomography (OCT) of the optic nerve is typically measured in micrometers (µm). This measurement assesses the thickness of the retinal nerve fiber layer (RNFL) and other structures of the optic nerve head, together with macular thickness.
The scale for RNFL thickness can vary depending on the specific protocol or software used, but it generally ranges from approximately 50 µm to 150 µm or more, with lower values indicating potential nerve damage or thinning associated with conditions like glaucoma.
Measured: 3 months
Light distorsion index (LDI)
The quantification of the presence of halos with Light distortion index (LDI) at month 3.
The Light Distortion Index (LDI) is typically measured in arbitrary units (AU). This index quantifies the degree of light distortion that occurs as light passes through the optical system, often used to assess the quality of vision and optical performance.
The scale for LDI can vary but usually encompasses a range where lower values indicate minimal distortion (better optical quality) and higher values indicate greater distortion (poorer optical quality).
Measured: 3 months
Patient satisfaction and spectacle independence
The spectacle independence assessed via the questionnaire Cataract Questionnaire (CATQUEST) before the surgery and at month 3.
The CATQUEST score generally ranges from 0 to 100, where a score of 0 indicates the worst visual function and quality of life, while a score of 100 represents the best possible vision and quality of life. This scale allows for a subjective assessment of how well a patient perceives their visual abilities and the difficulties they experience in daily tasks, helping to evaluate the effectiveness of treatment or intervention. Higher scores indicate better visual function and a more favorable quality of life related to vision.
Measured: 3 months
Dysphotopsia
The grade of dysphotopsia with Questionnaire of visual disturbances (QUVID) at month 3.
The QUVID typically employs a Likert scale ranging from 0 to 4, where participants rate the severity or frequency of symptoms such as glare, halos, or light sensitivity. In this context, a score closer to 0 indicates minimal or no dysphotopsia, while higher scores (e.g., 3 or 4) reflect more significant disturbances.
Measured: 3 months
Visual field stability
Change in visual field mean deviation (MD) before the surgery and at month 3.
The Mean Deviation (MD) in visual field testing is measured in decibels (dB). This value represents the average difference in sensitivity between the individual's threshold and the normal threshold for a range of points in the visual field. The scale for MD typically ranges from positive values (indicating better than average sensitivity) to negative values (indicating visual field loss).
A higher positive value (e.g., +2 dB) suggests that the visual field is better than normal, while a more negative value (e.g., -12 dB) indicates greater degrees of visual field loss.
Measured: 3 months
Patient satisfaction and spectacle independence
Patient-Reported Spectacle Independence Questionnaire score (PRSIQ) before the surgery and at month 3.
The PRSIQ usually employs a Likert scale, ranging from 0 to 5 or 1 to 5, where lower values indicate poorer visual quality or greater dissatisfaction and higher values indicate better visual quality or greater satisfaction. Each item in the questionnaire is rated based on the patient's experience, contributing to an overall score that reflects their perceived quality of vision and satisfaction with visual function.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start31 Jan 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GLAUCOMA 1, OPEN ANGLE, D (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OMIQ Research
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Idoia Goñi Guarro, OMIQ Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07436871
- Sponsor's protocol ID
- VOR2024-CG-001
- Status last verified
- Feb 2026
- First submitted
- 30 Jan 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial for the Evaluation and Comparison of Visual Results and Patient Satisfaction in Patients With Primary Open-angle Glaucoma After Bilateral Implantation of an Extended Range of Vision Intraocular Lens Compared to a Monofocal Lens.
- ClinicalTrials.gov ID
- NCT07436871
- Acronym / sponsor ID
- VOR2024-CG-001
- Conditions
- GLAUCOMA 1, OPEN ANGLE, D (Disorder), Cataract
- Keywords
- cataract surgery, Extended depth of focus intraocular lens, Primary open-angle glaucoma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- OMIQ ResearchResearch network
- Study start
- 31 Jan 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cataract is the leading cause of reversible vision loss, while glaucoma remains the primary cause of irreversible blindness, often impairing contrast sensitivity (CS), glare tolerance, and dark adaptation. These visual challenges are particularly relevant when selecting intraocular lenses (IOLs) for glaucoma patients undergoing cataract surgery.
Monofocal IOLs are the safest and most commonly used option for glaucoma patients due to their optical simplicity and low incidence of photic phenomena, though they do not provide spectacle independence for near or intermediate vision. Multifocal IOLs (MFIOLs), while offering greater spectacle independence, are relatively contraindicated in glaucoma due to increased visual disturbances like glare and halos.
Extended Depth of Focus (EDOF) IOLs offer an intermediate solution, using advanced optics to provide a continuous range of vision and fewer photic disturbances than MFIOLs. EDOF lenses have demonstrated good uncorrected distance and intermediate visual acuity in patients with mild to moderate glaucoma, with promising CS outcomes and high patient satisfaction. However, findings on CS performance remain inconsistent across studies.
Given these considerations, this study seeks to determine whether EDOF IOLs can be a viable alternative to monofocal lenses in glaucoma patients, potentially expanding their options for spectacle independence without compromising visual quality. The trial, conducted at OMIQ (Barcelona), will directly compare an EDOF IOL and a monofocal IOL made from the same material to assess their effects on visual acuity, contrast sensitivity, and photic phenomena in this specific patient population.
Detailed description
While cataract is the most prevalent cause of reversible loss of vision, glaucoma remains the leading cause of irreversible blindness, characterized by a progressive optic neuropathy with degeneration of retinal ganglion cells and visual field loss. Glaucoma negatively affects low-luminance contrast sensitivity, glare symptoms, and dark adaptation time more frequently than any other domain. Therefore, when choosing the type of lens to implant in these patients, concerns arise regarding contrast sensitivity (CS) loss and subjective visual disturbances, which may be more debilitating and can also be a limitation when choosing IOLs.
Monofocal IOLs have been shown to be the safest IOL choice for patients with glaucoma. Multifocal IOLs provide spectacle independence but, due to the technology used combined with the pathological changes in glaucoma, tey can cause more visual disturbances, which makes them a relative contraindication in eyes with glaucoma.
Recent studies have demonstrated that EDOF IOLs can be safely be implanted in eyes with mild, pre-perimetric open-angle glaucoma with favourable uncorrected distance and intermediate visual acuity outcomes. Additionally, contrast sensitivity measurements also have been shown to be favourable in this patients and satisfactory spectacle independence and patient satisfaction in the subjective questionnaire.
However, it is yet unknown if EDOF IOLs could be an equal or a better option in patients suffering from cataracts and glaucoma, compared to a Monofocal lens made of the same material, since this could provide wider options when choosing the IOL and could offer spectacle independence for intermediate and distant vision for these patients.
Rationale and positioning with regard to the state-of-the-art Cataract surgery is one of the most performed surgeries worldwide, where the natural lens of the eye is removed and replaced by an artificial intraocular lens (IOL) with the aim of replacing its functions of focusing on objects at different distances. While cataract is the most prevalent cause of reversible loss of vision, glaucoma remains the leading cause of irreversible blindness, characterized by a progressive optic neuropathy with degeneration of retinal ganglion cells and visual field loss. It is estimated that one in five people undergoing cataract surgery have glaucoma or ocular hypertension, with the incidence of both cataract and glaucoma increasing with age.
Glaucoma negatively affects low-luminance contrast sensitivity, glare symptoms, and dark adaptation time and extent. Patients report problems with lighting and dark adaptation more frequently than any other domain. These problems worsen with progressing visual field loss. Some studies have reported that early-stage glaucoma patients experience significantly more difficulties in low-luminance or changing lighting conditions than age-matched controls. Therefore, when choosing the type of lens to implant in these patients, concerns arise regarding contrast sensitivity (CS) loss and subjective visual disturbances such as glares and haloes, which may be more debilitating and may be also a limitation when choosing certain IOLs.
Currently, there are four main groups of IOLs: monofocal, enhanced monofocal, extended depth of focus (EDOF), and multifocal lenses. All of them provide different types of vision with different types of optical technology, which can make the patient to be more or less a candidate to wear them.
Monofocal IOLs provide excellent outcomes for distant vision, with the benefit of generally low cost and low frequency of photic phenomena such as glares and haloes.Therefore, they are the safest IOL choice for patients with pre-existing ocular pathology, like glaucoma, as they do not split light. However, as they only provide one focus point, they fail to deliver spectacle independence for near and intermediate vision.
Compared with traditional monofocal IOLs, premium IOLs, like Multifocal (MF) and Extended Depht-of-Focus (EDOF), offer the benefit of better unaided visual acuity, greater spectacle independence, and higher patient satisfaction.
MFIOLs, come in varying optical designs, such as diffractive, refractive, bifocal, trifocal, or hybrid IOLs, and provide multiple focal points, which allows the patient to see at different distances. However, pathological changes in glaucoma may also potentially interact with the optical effects of MFIOLs, as they tend to cause more halo or glare symptoms due to light scattering at the transitional zone between the distant and near focus of the lens, fact that makes them a relative contraindication in eyes with glaucoma.
EDOF IOLs use a recent technology that creates a single elongated focal point to enhance depth of focus and range of vision, effectively providing satisfactory near and intermediate vision while addressing limitations of MFIOLs, including negative photic phenomena such as glares and haloes. In addition, they also have provided superior intermediate and near vision and a similar visual disturbance profile compared with an aspheric monofocal IOL.
They enhance correction of chromatic aberration and maintain good CS that may be comparable to that of monofocal IOLs. Due to this characteristics, this type of lenses may be an option for glaucoma patients.
EDOF IOLs' behaviour is still not well understood as there have been conflicting results regarding CS outcomes. Certain studies have demonstrated a decrease in CS in eyes with EDOF IOLs under scotopic conditions, compared to eyes with monofocal IOLs while other studies reported no significant difference, and some others reported that EDOF IOLs performed significantly better than trifocal IOLs under both photopic and scotopic conditions. However, new EDOF IOLs have appeared safe and efficacious when implanting it patients with early to moderate bilateral glaucoma, warranting further studies in this population.
Today, choosing a monofocal IOL in patients with glaucoma is the most recommended option and the safest one, given the lack of interference of its optical technology with the optico-pathological changes produced by glaucoma. Most IOLs today use a new type of optical technology that allows the patient to be spectacles independent or independent for near and intermediate vision, which is a great advantage. However, this type of technology is not well tolerated by glaucoma patients, meaning that they have fewer options when choosing an IOL compared to the standard population, that they cannot benefit from this premium technology, and that, therefore, it makes them dependent on glasses for near and intermediate vision. However, despite controversies, EDOF IOLs have proven to be somehow effective in glaucoma patients.This study aims to find out if an EDOF IOL could help to open up a door for these patients, by analysing its behavior compared to a monofocal lens made of the same material and by obtaining the effect of this lens on the visual acuity in at different distances and, additionally, to evaluate the CS and the photopic phenomena like glares and halos.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cataract, glaucoma, monofocal intraocular lens | Active comparator | Procedure: Cataract surgery (Monofocal intraocular lens implantation)Bilateral cataract surgery in patients with primary open-angle glaucoma receiving monofocal intraocular lens implantation (n = 37 in this study arm). |
| cataract, glaucoma, Extended range of focus intraocular lens | Experimental | Procedure: cataract surgery (Extended depht of focus intraocular lens implantation)Bilateral cataract surgery in patients with primary open-angle glaucoma receiving extended range of focus intraocular lens implantation (n = 37 in this study arm). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients of any sex aged 18 years or older willing to participate and sign the informed consent form.
- Clinically significant cataracts in both eyes.
- Patients clinically diagnosed of primary open angle glaucoma (POAG) in both eyes.
- Early to moderate POAG, as defined by a mean deviation in the Humphrey Visual Field Analyzer (HFA) no worse than ≤ -12 dB and worse ≥ -2 dB at least in one eye, using a 24-2 SITA standard strategy
- Two visual field tests without progression and stability of RNFL in Optical Coherence Tomography (OCT) thickness remaining same or less than 10 um in the previous 6 months, with pharmacologically controlled IOP in both eyes <21mmHg.
Key exclusion criteria (9 listed)
- Patients with uncontrolled glaucoma, defined as those with an IOP ≥21 mm Hg despite maximal medical therapy, requiring glaucoma surgery and/or laser in either eye in the next year.
- Pre-surgery refractive error requiring IOL implantation beyond the commercially available range.
- Patients with a not reliable visual field, a VFI ≤ 60% or defects of ≤ 10 dB in the 4 central points of the visual field.
- Any other form of glaucoma (pseudoexfoliative, severe forms of pigmentary, primary angle closure glaucoma, etc.), ocular hypertension, zonular instability or possible intuitive lens decentration after surgery.
- Patients with any previous glaucoma surgery or any other ocular surgery that can affect the results, or any ocular surgery in the previous six months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cataract surgery (Monofocal intraocular lens implantation)This intervention consists of bilateral cataract surgery, a microsurgical procedure in which the eye's natural, clouded lens is removed and replaced with an artificial intraocular lens (IOL) to restore clear vision. In this study, patients with early to moderate primary open-angle glaucoma (POAG) will receive either a monofocal or extended depth-of-focus (EDOF) IOL. The surgical technique involves standard phacoemulsification through a small corneal incision, followed by IOL implantation into the capsular bag. What distinguishes this intervention from others is the glaucoma-specific population, with perioperative protocols designed to minimize intraocular pressure fluctuations and preserve optic nerve function. Additionally, both IOLs share the same material and platform, allowing for an isolated comparison of optical design effects. | Procedure or surgery | cataract, glaucoma, monofocal intraocular lens |
| cataract surgery (Extended depht of focus intraocular lens implantation)This intervention consists of bilateral cataract surgery, a microsurgical procedure in which the eye's natural, clouded lens is removed and replaced with an artificial intraocular lens (IOL) to restore clear vision. In this study, patients with early to moderate primary open-angle glaucoma (POAG) will receive either a monofocal or extended depth-of-focus (EDOF) IOL. The surgical technique involves standard phacoemulsification through a small corneal incision, followed by IOL implantation into the capsular bag. What distinguishes this intervention from others is the glaucoma-specific population, with perioperative protocols designed to minimize intraocular pressure fluctuations and preserve optic nerve function. Additionally, both IOLs share the same material and platform, allowing for an isolated comparison of optical design effects. | Procedure or surgery | cataract, glaucoma, Extended range of focus intraocular lens |
Primary outcome
Binocular distance-corrected intermediate visual acuity (DCIVA)
Time frame: 3 months
The comparison of the binocular, distance-corrected intermediate visual acuity (bDCIVA) between groups at month 3. For the visual acuity assessments in this study, measurements will be expressed using LogMAR (Logarithm of the Minimum Angle of Resolution) units. The LogMAR scale provides a standardized way to quantify visual acuity, with higher values indicating worse vision. The range of LogMAR units typically spans from -0.3 (indicating excellent vision) to +2.0 (indicating severe visual impairment), ensuring a comprehensive evaluation of participants' visual performance.
11 secondary outcomes
bUDVA, bUIVA, bUNVA, bDCVA and bDCNVA
Time frame: 3 months
mUDVA, mUIVA, mUNVA, mDCDVA, mDCIVA and mDCNVA
Time frame: 3 months
Defocus curve
Time frame: 3 months
Mesopic and photopic contrast sensitivity
Time frame: 3 months
Visual field stability
Time frame: 3 months
OCT stability
Time frame: 3 months
Light distorsion index (LDI)
Time frame: 3 months
Patient satisfaction and spectacle independence
Time frame: 3 months
Dysphotopsia
Time frame: 3 months
Visual field stability
Time frame: 3 months
Patient satisfaction and spectacle independence
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Cataract surgery (Monofocal intraocular lens implantation) and cataract surgery (Extended depht of focus intraocular lens implantation) in people with GLAUCOMA 1, OPEN ANGLE, D (Disorder) and Cataract, run by OMIQ Research.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Binocular distance-corrected intermediate visual acuity (DCIVA) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.