CataractNCT06624826
Visual Performance of an Extended Depth of Focus IOL in an Emmetropic or Monovision Modality
A study testing Emmetropic modality and Monovision modality in people with Cataract, run by Prim. Prof. Dr. Oliver Findl, MBA at 1 site in Austria.
Trial summary
Comparison of the visual performance of a refractive extended depth of focus intraocular lens in an emmetropic or monovision modality Read more about this study
- Who is it for?
- Ages 21 to 105 years
- Conditions the study is for
- Cataract
- What is being tested?
- Emmetropic modality and Monovision modality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteAustria
- Study dates
- 1 Oct 2024to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 105 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age-related bilateral cataract
- Age 21 or older
- Visual acuity \> 0.05
- Axial length: 21.00-27.00mm
- Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically relevant
- Written informed consent prior to surgery
Who cannot join
- Active ocular disease (e.g chronic uveitis, diabetic retinopathy, chronic glaucoma not responsive to medication, corneal dystrophies, etc.) precluding good post-operative visual acuity
- Relevant other ophthalmic diseases such as pseudoexfoliation syndrome (PEX)
- Irregular astigmatism on corneal tomography
- Pronounced dry eye disease
- Previous ocular surgery or trauma
- Persons who are pregnant or nursing (pregnancy test will be taken in women of reproductive age)
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Vienna Institute for Research in Ocular Surgery
Vienna, Austria, 1140
Johannes Zeilinger, MD, 01 91021 57564, office@viros.at
Natascha Bayer, MSc, 01 91021 57564, office@viros.at
About this study
Official title: Difference in Visual Performance of a Refractive Extended Depth of Focus Intraocular Lens in an Emmetropic or Monovision Modality
Comparison of the visual performance of a refractive extended depth of focus intraocular lens in an emmetropic or monovision modality
Read the detailed description
With an expanding market of different types of intraocular lenses (IOL), spectacle independence is a rising aim in modern cataract surgery. The procedure has in many cases changed from a vision restoring to a presbyopia correcting approach. Although bilateral monofocal IOL implantation, aiming for emmetropia, leads to high levels of patient satisfaction for distance vision, spectacle dependence for reading and intermediate vision tasks is the usual result.
The option commonly used to achieve spectacle independence at intermediate distance (e.g., PC work) is the implantation of enhanced depth of focus (EDOF) IOLs. These IOLs have an extended far focus area which reaches to the intermediate distance, providing high-quality vision over a continuous range of focus, rather than distinct foci with blur in between. In the last years several technologies for EDOF IOLs appeared on the market. The spectrum ranges from small aperture design, bioanalogic design, to diffractive and non-diffractive optics. The disadvantage compared to monofocal lenses in all the technologies mentioned is the potentially worse distance vision and contrast sensitivity as well as dysphotopsia.
A new refractive EDOF lens segment with an extended depth of vision was introduced which promises an increased range of functional vision and less dysphotopsias compared to diffractive EDOF lenses. These non-diffractive IOLs are believed to be a presbyopia correcting alternative for people with existing corneal or macula pathologies, which would preclude them from receiving premium lenses because of the loss of light in the diffractive process. To increase spectacle independence for these patients, IOLs may be used in a monovision modality, with an offset of up to 1.5dpt. This method showed good results in the literature so far for monofocal and multifocal intraocular lenses.
Aim of the study is to compare a new non-diffractive EDOF-IOL, namely the PureSee, set for emmetropia or monovision.
120 eyes of 60 patients will be included into this study. Patients will be either randomized in the emmetropia or the monovision group
Follow-up visits will be 1 week after each surgery and 3 months post-surgically. During these visits, the clinical variables to be assessed will be visual acuity, stereopsis, contrast sensitivity, and binocular defocus curves.
- Conditions
- Cataract
- Being tested
- Emmetropic modality, Monovision modality
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emmetropic modalityDevice
PureSee IOL, emmetropic modality
Monovision modalityDevice
PureSee IOL, monovision modality
| Study group | Role | What they receive |
|---|---|---|
| PureSee Emmetropia | Experimental | Patient will receive the PureSee IOL with an emmetropic modality Receives: Device: Emmetropic modality |
| PureSee Monovision | Experimental | Patient will receive the PureSee IOL in a monovision modality Receives: Device: Monovision modality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corrected and uncorrected binocular visual acuity for near distance
Corrected and uncorrected binocular visual acuity for near distance will be assessed at 40 cm using ETDRS charts
Measured: 12 months
Secondary outcomes (4)
Corrected and uncorrected binocular visual acuity for distance
Corrected and uncorrected binocular visual acuity for distance will be assessed at 4 m using ETDRS charts
Measured: 12 months
Corrected and uncorrected binocular visual acuity for intermediate distance
Corrected and uncorrected binocular visual acuity for intermediate distance will be assessed at 66 cm using ETDRS charts
Measured: 12 months
Contrast sensitivity
Contrast sensitivity will be tested using the Optec Vision tester under mesopic and photopic conditions with and without an additional glare source
Measured: 12 months
Subjective quality of vision
Subjective quality of vision will be assessed using a questionnaire
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start1 Oct 2024
- Primary completion1 Oct 2025 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prim. Prof. Dr. Oliver Findl, MBA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery
- Investigators
- Oliver Findl, Prim. Prof. Dr., Principal investigator, Vienna Institute for Research in Ocular Surgery (VIROS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06624826
- Sponsor's protocol ID
- PureSee MiniMonovision
- Status last verified
- Oct 2024
- First submitted
- 1 Oct 2024
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Difference in Visual Performance of a Refractive Extended Depth of Focus Intraocular Lens in an Emmetropic or Monovision Modality
- ClinicalTrials.gov ID
- NCT06624826
- Acronym / sponsor ID
- PureSee MiniMonovision
- Conditions
- Cataract
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Prim. Prof. Dr. Oliver Findl, MBAUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 3 Oct 2024 (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.
Comparison of the visual performance of a refractive extended depth of focus intraocular lens in an emmetropic or monovision modality
Detailed description
With an expanding market of different types of intraocular lenses (IOL), spectacle independence is a rising aim in modern cataract surgery. The procedure has in many cases changed from a vision restoring to a presbyopia correcting approach. Although bilateral monofocal IOL implantation, aiming for emmetropia, leads to high levels of patient satisfaction for distance vision, spectacle dependence for reading and intermediate vision tasks is the usual result.
The option commonly used to achieve spectacle independence at intermediate distance (e.g., PC work) is the implantation of enhanced depth of focus (EDOF) IOLs. These IOLs have an extended far focus area which reaches to the intermediate distance, providing high-quality vision over a continuous range of focus, rather than distinct foci with blur in between. In the last years several technologies for EDOF IOLs appeared on the market. The spectrum ranges from small aperture design, bioanalogic design, to diffractive and non-diffractive optics. The disadvantage compared to monofocal lenses in all the technologies mentioned is the potentially worse distance vision and contrast sensitivity as well as dysphotopsia.
A new refractive EDOF lens segment with an extended depth of vision was introduced which promises an increased range of functional vision and less dysphotopsias compared to diffractive EDOF lenses. These non-diffractive IOLs are believed to be a presbyopia correcting alternative for people with existing corneal or macula pathologies, which would preclude them from receiving premium lenses because of the loss of light in the diffractive process. To increase spectacle independence for these patients, IOLs may be used in a monovision modality, with an offset of up to 1.5dpt. This method showed good results in the literature so far for monofocal and multifocal intraocular lenses.
Aim of the study is to compare a new non-diffractive EDOF-IOL, namely the PureSee, set for emmetropia or monovision.
120 eyes of 60 patients will be included into this study. Patients will be either randomized in the emmetropia or the monovision group
Follow-up visits will be 1 week after each surgery and 3 months post-surgically. During these visits, the clinical variables to be assessed will be visual acuity, stereopsis, contrast sensitivity, and binocular defocus curves.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PureSee Emmetropia | Experimental | Device: Emmetropic modalityPatient will receive the PureSee IOL with an emmetropic modality |
| PureSee Monovision | Experimental | Device: Monovision modalityPatient will receive the PureSee IOL in a monovision modality |
Who may qualify
- Ages
- 21 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age-related bilateral cataract
- Age 21 or older
- Visual acuity \> 0.05
- Axial length: 21.00-27.00mm
- Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically relevant
Key exclusion criteria (6 listed)
- Active ocular disease (e.g chronic uveitis, diabetic retinopathy, chronic glaucoma not responsive to medication, corneal dystrophies, etc.) precluding good post-operative visual acuity
- Relevant other ophthalmic diseases such as pseudoexfoliation syndrome (PEX)
- Irregular astigmatism on corneal tomography
- Pronounced dry eye disease
- Previous ocular surgery or trauma
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 |
|---|---|---|
| Emmetropic modalityPureSee IOL, emmetropic modality | Device | PureSee Emmetropia |
| Monovision modalityPureSee IOL, monovision modality | Device | PureSee Monovision |
Primary outcome
Corrected and uncorrected binocular visual acuity for near distance
Time frame: 12 months
Corrected and uncorrected binocular visual acuity for near distance will be assessed at 40 cm using ETDRS charts
4 secondary outcomes
Corrected and uncorrected binocular visual acuity for distance
Time frame: 12 months
Corrected and uncorrected binocular visual acuity for intermediate distance
Time frame: 12 months
Contrast sensitivity
Time frame: 12 months
Subjective quality of vision
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Oliver Findl, Prim. Prof. Dr. principal investigator
Vienna Institute for Research in Ocular Surgery (VIROS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emmetropic modality and Monovision modality in people with Cataract, run by Prim. Prof. Dr. Oliver Findl, MBA at 1 site in Austria.
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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Johannes Zeilinger, MD (01 91021 57564, office@viros.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corrected and uncorrected binocular visual acuity for near distance (time frame: 12 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 3 Oct 2024.