CataractTRIEDOF IOLSNCT07295119
Evaluation Of Patient Satisfaction And Quality Of Vision After EDOF Or Trifocal IOL Implantation
A study testing Fusion EDOF IOL Implantation and Bilateral Trifocal IOL Implantation in people with Cataract and Presbyopia Correction, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.
Trial summary
Brief Summary of the Study The goal of this clinical study is to compare the quality of vision and patient satisfaction after cataract surgery using two different approaches to multifocal intraocular lenses (IOLs). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract, Presbyopia Correction
- What is being tested?
- Fusion EDOF IOL Implantation and Bilateral Trifocal IOL Implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteItaly
- Study dates
- 24 Apr 2023to 13 Nov 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older.
- Diagnosis of age-related cataract in both eyes requiring bilateral cataract surgery.
- Corneal astigmatism 0.50 diopters or less in each eye.
- No other media opacities except cataract.
- Regular corneal shape without abnormal curvature or high-order aberrations on topography/aberrometry.
- Intraocular lens spherical power between +10.00 and +30.00 diopters according to biometry and IOL calculation.
Show all 9Show fewer
- Willing and able to undergo surgery in the second eye within 7 days of the first-eye surgery.
- Willing and able to attend all scheduled follow-up visits, including the 3-month visit.
- Able to understand the study information and provide written informed consent.
Who cannot join
- Any prior ocular surgery in either eye.
- Any concomitant ocular disease that could affect visual outcomes (for example glaucoma, retinal disease, significant macular pathology, corneal dystrophy or degeneration, keratoconus, significant dry eye not controlled with treatment).
- Clinically significant irregular astigmatism or corneal scarring.
- Any intraoperative complication during cataract surgery that could compromise IOL position or visual outcome (such as posterior capsule rupture, zonular dialysis); such eyes will be excluded from the analysis set.
- Significant posterior capsule opacification before the 3-month outcome visit requiring YAG capsulotomy.
- Systemic disease or neurological condition that, in the investigator's opinion, may affect visual function, ability to complete testing (for example halometry, questionnaires), or study participation.
- Cognitive impairment or psychiatric condition that precludes giving informed consent or complying with study procedures.
- Participation in another interventional clinical study that could interfere with outcomes of this trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Interventional Clinical Trial Involving Patient Undergoing Cataract Surgery Aiming To Evaluate The Halo Perception After Implantation Of Extended Depth Of Focus Intraocular Lenses (IOLs) Compared To Trifocal IOLs
Brief Summary of the Study
The goal of this clinical study is to compare the quality of vision and patient satisfaction after cataract surgery using two different approaches to multifocal intraocular lenses (IOLs). These lenses replace the natural lens removed during surgery and are designed to allow clear vision at near, intermediate, and far distances, reducing or eliminating the need for glasses.
Read more
The study aims to understand whether using two different lens models-Mini Well in the dominant eye and Mini Well Proxa in the non-dominant eye-produces different levels of visual quality, glare, halos, or overall satisfaction compared with implanting the same trifocal lens model (FineVision POD F) in both eyes.
All lenses included in the study are approved medical devices already available on the market.
Who can participate? Adults scheduled to undergo cataract surgery in both eyes at the Ophthalmology Unit of the Policlinico of Verona may be eligible. A total of 36 participants will take part.
How does the study work?
Participation is voluntary. After informed consent, participants are randomly assigned (like flipping a coin) to one of two groups:
- Experimental group: Mini Well lens in the dominant eye and Mini Well Proxa lens in the other eye.
- Comparison group: FineVision POD F lens in both eyes.
Neither participants nor the clinical team conducting postoperative assessments will know which lenses were implanted (blinded study).
Before surgery, participants undergo a standard ophthalmic evaluation, including visual acuity tests and measurements of eye structure. After surgery in each eye, follow-up visits take place at approximately 1-2 days, 14 days, 1 month, and 3 months. During these visits, clinicians assess visual performance, eye health, and any symptoms. At the 3-month visit, participants also complete a questionnaire on vision quality and satisfaction, and undergo a specific test to measure perception of halos.
Participant responsibilities Participants are asked to attend all scheduled visits, follow medical instructions, use prescribed medications, and promptly report any symptoms or concerns.
Potential benefits Participants may experience improved vision at all distances with reduced dependence on glasses. However, personal benefit cannot be guaranteed. The study is expected to help determine whether combining two different lens models provides better visual outcomes than using the same lens in both eyes.
Risks and discomforts Risks are the same as those associated with standard cataract surgery and multifocal IOLs, including rare surgical complications and the possibility of visual disturbances such as glare or halos. These symptoms are common with multifocal lenses and often diminish over time, but in rare cases may require further intervention. All adverse events will be closely monitored.
Alternatives Patients may choose standard cataract surgery with monofocal lenses, which usually provide clear vision at one distance and may still require glasses for intermediate or near vision. Declining participation will not affect the quality of care.
Duration Each participant's involvement lasts about 4 months.
Voluntary participation Participants may withdraw at any time without affecting their medical care.
Confidentiality All personal and medical information will be handled confidentially and used only according to privacy regulations. Study results may be published anonymously in scientific reports.
Read the detailed description
This study is designed to evaluate patient-reported satisfaction and visual quality following bilateral cataract surgery with implantation of two different multifocal intraocular lens (IOL) strategies. The investigation compares a mixed-modality combination of complementary extended-depth-of-focus (EDOF) IOLs with a bilateral trifocal IOL approach. Although all lenses included in this research are CE-marked and commercially available, they differ in optical architecture and light-distribution profiles, offering an opportunity to assess whether pairing distinct optical designs between eyes can mitigate dysphotopsia while maintaining a full range of functional vision.
The scientific rationale derives from the known trade-offs associated with presbyopia-correcting IOLs. Trifocal designs distribute light to three focal points and provide distance, intermediate, and near performance, but may also induce photic phenomena such as halos or glare. EDOF platforms extend the depth of focus through controlled modulation of spherical aberration or wavefront shaping, with the goal of improving image continuity and contrast. The Mini Well and Mini Well Proxa lenses, which incorporate different wavefront-engineering profiles, are hypothesized to act synergistically when implanted contralaterally. This design may reduce dysphotopsia intensity by balancing light distribution asymmetrically across the visual system. In contrast, bilateral FineVision POD F implantation represents a uniform, widely adopted trifocal strategy.
The study is conducted at the Ophthalmology Unit of the Policlinico of Verona and enrolls 36 patients requiring routine bilateral cataract extraction. Participants are randomized 1:1 to one of the two treatment groups. The allocation sequence is computer-generated and concealed using a predefined method to ensure unbiased assignment. Masking is maintained at the patient level; patients are not informed of the IOL type they receive. Outcome assessors remain masked whenever feasible, although surgeons cannot be masked due to the nature of the intervention.
The protocol follows a standardized clinical workflow. Preoperative evaluation includes refraction, slit-lamp biomicroscopy, tonometry, retinal assessment, and biometric measurements using optical biometry to calculate IOL power. Cataract extraction is performed using a uniform phacoemulsification technique, with efforts to standardize incision size and capsulorhexis configuration. Postoperative care follows standard clinical practice and includes scheduled visits at early, intermediate, and late postoperative time points for both eyes.
Across follow-up, participants undergo routine ophthalmic assessments and standardized testing. At the final postoperative visit, patients complete structured questionnaires addressing visual function, satisfaction, spectacle independence, and visual disturbances. Objective quantification of dysphotopsia, including halo intensity and size, is also performed using validated halometry tools. These assessments provide combined subjective and objective characterization of visual quality.
The anticipated duration of participation is approximately four months, including preoperative evaluation, surgery for each eye, and postoperative follow-up through the three-month visit after the second eye procedure. Study data are collected in case report forms and stored under coded identifiers to ensure confidentiality. Data management follows applicable privacy legislation and good clinical practice guidelines. Quality assurance procedures include verification of source documents, consistency checks for questionnaire scoring, and calibration of devices used for optical quality measurements.
By comparing a contralateral EDOF-based strategy with bilateral trifocal implantation, this investigation seeks to clarify whether mixing complementary optical designs yields advantages in patient satisfaction, visual comfort, or dysphotopsia reduction. The findings are expected to contribute evidence relevant to presbyopia-correcting IOL selection, optimization of binocular optical planning, and patient counseling in cataract surgery.
- Conditions
- Cataract, Presbyopia Correction
- Being tested
- Fusion EDOF IOL Implantation, Bilateral Trifocal IOL Implantation
- Keywords
- EDOF IOL, Trifocal IOL, Halo perception, spectacle indipendente
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fusion EDOF IOL ImplantationDevice
Bilateral cataract extraction followed by implantation of two different extended-depth-of-focus intraocular lenses in opposite eyes. The dominant eye receives an EDOF lens based on wavefront-modulation optics (Mini Well), while the non-dominant eye receives a complementary EDOF lens optimized for near to intermediate performance (Mini Well Proxa). This contralateral design is intended to extend functional vision range and modulate dysphotopsia by combining distinct optical profiles within the same participant.
Bilateral Trifocal IOL ImplantationDevice
Bilateral cataract extraction followed by implantation of the same trifocal presbyopia-correcting intraocular lens in both eyes (FineVision POD F). This lens allocates light across three focal points-distance, intermediate, and near-representing a standard multifocal approa
| Study group | Role | What they receive |
|---|---|---|
| Fusion EDOF IOL | Experimental | Participants undergo bilateral cataract surgery with contralateral implantation of two different extended-depth-of-focus intraocular lenses. The Mini Well IOL is implanted in the dominant eye and the Mini Well Proxa IOL in the non-dominant eye. This combined optical strategy is intended to provide continuous functional vision across distances while potentially reducing dysphotopsia by leveraging complementary lens designs. All procedures follow standardized surgical and postoperative protocols. Receives: Device: Fusion EDOF IOL Implantation |
| Bilateral Trifocal IOL | Active comparator | Participants undergo bilateral cataract surgery with implantation of the same trifocal intraocular lens, the FineVision POD F, in both eyes. The lens distributes light across distance, intermediate, and near focal points and represents a standard presbyopia-correcting approach. Surgical technique and postoperative management are consistent with those used in the experimental arm to ensure comparability. Receives: Device: Bilateral Trifocal IOL Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective halo area under binocular vision.
Objective halo area under binocular vision, defined as the quantitative measurement of halo perception expressed as the total area (cm²) of the halo pattern surrounding a central light stimulus under binocular conditions, assessed 3 months after bilateral intraocular lens (IOL) implantation (3 months post-second eye surgery). Higher halo area values indicate more pronounced photic phenomena (worse halo disturbance), whereas lower values indicate fewer or less extensive halos (better outcome)
Measured: 3 months post-second eye surgery.
Secondary outcomes (7)
Uncorrected Distance Visual Acuity (UDVA)
Monocular and binocular uncorrected distance visual acuity (UDVA) at 4 m, measured in logarithm of the minimum angle of resolution (logMAR) units, assessed at 1 and 3 months postoperatively. The logMAR scale has lower values indicating better visual acuity, with 0.0 logMAR corresponding to 20/20 Snellen-equivalent vision and negative values representing better than 20/20.
Measured: 1 and 3 months postoperatively.
Uncorrected Intermediate Visual Acuity (UIVA)
Monocular and binocular uncorrected intermediate visual acuity (UIVA) at 80 cm, measured in logarithm of the minimum angle of resolution (logMAR) units, assessed at 1 and 3 months postoperatively. The logMAR scale has lower values indicating better visual acuity, with 0.0 logMAR corresponding to 20/20 Snellen-equivalent vision and negative values representing better than 20/20.
Measured: 1 and 3 months postoperatively.
Uncorrected Near Visual Acuity (UNVA)
Monocular and binocular uncorrected near visual acuity (UNVA) at 40 cm, measured in logarithm of the minimum angle of resolution (logMAR) units, assessed 3 months postoperatively. The logMAR scale has lower values indicating better visual acuity, with 0.0 logMAR corresponding to 20/20 Snellen-equivalent vision and negative values representing better than 20/20.
Measured: 3 months postoperatively.
Contrast Sensitivity (CS)
Binocular contrast sensitivity measured with the CSV-1000 under photopic and scotopic conditions at spatial frequencies of 3, 6, 12, and 18 cycles per degree (cpd), assessed 3 months postoperatively. Contrast sensitivity is reported in log units for each spatial frequency, with higher values indicating better visual performance (greater ability to detect low-contrast targets).
Measured: 3 months postoperatively.
Strehl Ratio
Strehl ratio of the total eye measured with the OSIRIS-T aberrometer at a 4 mm pupil diameter, 3 months postoperatively. The Strehl ratio is a dimensionless index of optical quality ranging from 0 to 1, with values closer to 1 indicating better optical quality and less optical degradation
Measured: 3 months postoperatively
Root Mean Square
Root Mean Square (RMS) higher-order aberration (µm) of the total eye measured with the OSIRIS-T aberrometer at a 4 mm pupil diameter, 3 months postoperatively. Lower RMS values indicate fewer aberrations and thus a better optical outcome; there is no fixed minimum or maximum, but values in healthy eyes are typically in the submicrometer range.
Measured: 3 months postoperatively
Quality of Life (NEI RQL-42 Score)
Patient-reported satisfaction assessed using the National Eye Institute Refractive Error Quality of Life-42 (NEI-RQL-42) questionnaire at 3 months postoperatively. The NEI-RQL-42 provides multi-domain scores transformed to a 0-100 scale, with higher scores indicating better refractive error-related quality of life and greater satisfaction with vision.
Measured: 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start24 Apr 2023
- Primary completion13 Nov 2024
- Study completion13 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Model description
- This is a two-arm, parallel-group, randomized clinical study in which each participant receives bilateral cataract surgery followed by implantation of prespecified intraocular lenses (IOLs) according to group assignment. Participants in the experimental arm receive a mixed-modality approach using two different EDOF IOL models implanted contralaterally, while participants in the control arm receive bilateral implantation of the same trifocal IOL model. Randomization occurs at the participant level, and both eyes follow the allocated intervention strategy. All assessments and follow-up visits proceed in parallel for both groups using standardized procedures.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emilio Pedrotti, Azienda Ospedaliera Universitaria Integrata Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07295119
- Sponsor's protocol ID
- 74253-12/12/2022
- Acronym
- TRIEDOF IOLS
- Status last verified
- Dec 2025
- First submitted
- 3 Dec 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data that underlie the main published results (including primary and secondary outcomes) will be shared. Data will be available beginning 12 months after publication of the primary manuscript and for 5 years thereafter. Data will be shared with qualified researchers for methods-sound proposals focused on cataract surgery, intraocular lenses, or visual outcomes, after approval by the sponsor and execution of a data use agreement. Requests should be sent to the corresponding investigator by email.
Publications
Pedrotti E, Neri E, Bonacci E, Barosco G, Galzignato A, Montresor A, Rodella A, De Gregorio A, Bosello F, Marchini G. Extended Depth of Focus Versus Monofocal IOLs in Patients With High Myopia: Objective and Subjective Visual Outcomes. J Refract Surg. 2022 Mar;38(3):158-166. doi: 10.3928/1081597X-20211220-01. Epub 2022 Mar 1.
PubMed 35275002Pedrotti E, Chierego C, Talli PM, Selvi F, Galzignato A, Neri E, Barosco G, Montresor A, Rodella A, Marchini G. Extended Depth of Focus Versus Monofocal IOLs: Objective and Subjective Visual Outcomes. J Refract Surg. 2020 Apr 1;36(4):214-222. doi: 10.3928/1081597X-20200212-01.
PubMed 32267951de Medeiros AL, de Araujo Rolim AG, Motta AFP, Ventura BV, Vilar C, Chaves MAPD, Carricondo PC, Hida WT. Comparison of visual outcomes after bilateral implantation of a diffractive trifocal intraocular lens and blended implantation of an extended depth of focus intraocular lens with a diffractive bifocal intraocular lens. Clin Ophthalmol. 2017 Oct 26;11:1911-1916. doi: 10.2147/OPTH.S145945. eCollection 2017.
PubMed 29138533Khandelwal SS, Jun JJ, Mak S, Booth MS, Shekelle PG. Effectiveness of multifocal and monofocal intraocular lenses for cataract surgery and lens replacement: a systematic review and meta-analysis. Graefes Arch Clin Exp Ophthalmol. 2019 May;257(5):863-875. doi: 10.1007/s00417-018-04218-6. Epub 2019 Jan 10.
PubMed 30627791Calladine D, Evans JR, Shah S, Leyland M. Multifocal versus monofocal intraocular lenses after cataract extraction. Cochrane Database Syst Rev. 2012 Sep 12;(9):CD003169. doi: 10.1002/14651858.CD003169.pub3.
PubMed 22972061
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Interventional Clinical Trial Involving Patient Undergoing Cataract Surgery Aiming To Evaluate The Halo Perception After Implantation Of Extended Depth Of Focus Intraocular Lenses (IOLs) Compared To Trifocal IOLs
- ClinicalTrials.gov ID
- NCT07295119
- Acronym / sponsor ID
- TRIEDOF IOLS / 74253-12/12/2022
- Conditions
- Cataract, Presbyopia Correction
- Keywords
- EDOF IOL, Trifocal IOL, Halo perception, spectacle indipendente
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata VeronaUniversity, hospital or other
- Study start
- 24 Apr 2023 (actual)
- Primary completion
- 13 Nov 2024 (actual)
- Study completion
- 13 Nov 2024 (actual)
- First posted
- 19 Dec 2025 (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.
Brief Summary of the Study
The goal of this clinical study is to compare the quality of vision and patient satisfaction after cataract surgery using two different approaches to multifocal intraocular lenses (IOLs). These lenses replace the natural lens removed during surgery and are designed to allow clear vision at near, intermediate, and far distances, reducing or eliminating the need for glasses.
The study aims to understand whether using two different lens models-Mini Well in the dominant eye and Mini Well Proxa in the non-dominant eye-produces different levels of visual quality, glare, halos, or overall satisfaction compared with implanting the same trifocal lens model (FineVision POD F) in both eyes.
All lenses included in the study are approved medical devices already available on the market.
Who can participate? Adults scheduled to undergo cataract surgery in both eyes at the Ophthalmology Unit of the Policlinico of Verona may be eligible. A total of 36 participants will take part.
How does the study work?
Participation is voluntary. After informed consent, participants are randomly assigned (like flipping a coin) to one of two groups:
- Experimental group: Mini Well lens in the dominant eye and Mini Well Proxa lens in the other eye.
- Comparison group: FineVision POD F lens in both eyes.
Neither participants nor the clinical team conducting postoperative assessments will know which lenses were implanted (blinded study).
Before surgery, participants undergo a standard ophthalmic evaluation, including visual acuity tests and measurements of eye structure. After surgery in each eye, follow-up visits take place at approximately 1-2 days, 14 days, 1 month, and 3 months. During these visits, clinicians assess visual performance, eye health, and any symptoms. At the 3-month visit, participants also complete a questionnaire on vision quality and satisfaction, and undergo a specific test to measure perception of halos.
Participant responsibilities Participants are asked to attend all scheduled visits, follow medical instructions, use prescribed medications, and promptly report any symptoms or concerns.
Potential benefits Participants may experience improved vision at all distances with reduced dependence on glasses. However, personal benefit cannot be guaranteed. The study is expected to help determine whether combining two different lens models provides better visual outcomes than using the same lens in both eyes.
Risks and discomforts Risks are the same as those associated with standard cataract surgery and multifocal IOLs, including rare surgical complications and the possibility of visual disturbances such as glare or halos. These symptoms are common with multifocal lenses and often diminish over time, but in rare cases may require further intervention. All adverse events will be closely monitored.
Alternatives Patients may choose standard cataract surgery with monofocal lenses, which usually provide clear vision at one distance and may still require glasses for intermediate or near vision. Declining participation will not affect the quality of care.
Duration Each participant's involvement lasts about 4 months.
Voluntary participation Participants may withdraw at any time without affecting their medical care.
Confidentiality All personal and medical information will be handled confidentially and used only according to privacy regulations. Study results may be published anonymously in scientific reports.
Detailed description
This study is designed to evaluate patient-reported satisfaction and visual quality following bilateral cataract surgery with implantation of two different multifocal intraocular lens (IOL) strategies. The investigation compares a mixed-modality combination of complementary extended-depth-of-focus (EDOF) IOLs with a bilateral trifocal IOL approach. Although all lenses included in this research are CE-marked and commercially available, they differ in optical architecture and light-distribution profiles, offering an opportunity to assess whether pairing distinct optical designs between eyes can mitigate dysphotopsia while maintaining a full range of functional vision.
The scientific rationale derives from the known trade-offs associated with presbyopia-correcting IOLs. Trifocal designs distribute light to three focal points and provide distance, intermediate, and near performance, but may also induce photic phenomena such as halos or glare. EDOF platforms extend the depth of focus through controlled modulation of spherical aberration or wavefront shaping, with the goal of improving image continuity and contrast. The Mini Well and Mini Well Proxa lenses, which incorporate different wavefront-engineering profiles, are hypothesized to act synergistically when implanted contralaterally. This design may reduce dysphotopsia intensity by balancing light distribution asymmetrically across the visual system. In contrast, bilateral FineVision POD F implantation represents a uniform, widely adopted trifocal strategy.
The study is conducted at the Ophthalmology Unit of the Policlinico of Verona and enrolls 36 patients requiring routine bilateral cataract extraction. Participants are randomized 1:1 to one of the two treatment groups. The allocation sequence is computer-generated and concealed using a predefined method to ensure unbiased assignment. Masking is maintained at the patient level; patients are not informed of the IOL type they receive. Outcome assessors remain masked whenever feasible, although surgeons cannot be masked due to the nature of the intervention.
The protocol follows a standardized clinical workflow. Preoperative evaluation includes refraction, slit-lamp biomicroscopy, tonometry, retinal assessment, and biometric measurements using optical biometry to calculate IOL power. Cataract extraction is performed using a uniform phacoemulsification technique, with efforts to standardize incision size and capsulorhexis configuration. Postoperative care follows standard clinical practice and includes scheduled visits at early, intermediate, and late postoperative time points for both eyes.
Across follow-up, participants undergo routine ophthalmic assessments and standardized testing. At the final postoperative visit, patients complete structured questionnaires addressing visual function, satisfaction, spectacle independence, and visual disturbances. Objective quantification of dysphotopsia, including halo intensity and size, is also performed using validated halometry tools. These assessments provide combined subjective and objective characterization of visual quality.
The anticipated duration of participation is approximately four months, including preoperative evaluation, surgery for each eye, and postoperative follow-up through the three-month visit after the second eye procedure. Study data are collected in case report forms and stored under coded identifiers to ensure confidentiality. Data management follows applicable privacy legislation and good clinical practice guidelines. Quality assurance procedures include verification of source documents, consistency checks for questionnaire scoring, and calibration of devices used for optical quality measurements.
By comparing a contralateral EDOF-based strategy with bilateral trifocal implantation, this investigation seeks to clarify whether mixing complementary optical designs yields advantages in patient satisfaction, visual comfort, or dysphotopsia reduction. The findings are expected to contribute evidence relevant to presbyopia-correcting IOL selection, optimization of binocular optical planning, and patient counseling in cataract surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a two-arm, parallel-group, randomized clinical study in which each participant receives bilateral cataract surgery followed by implantation of prespecified intraocular lenses (IOLs) according to group assignment. Participants in the experimental arm receive a mixed-modality approach using two different EDOF IOL models implanted contralaterally, while participants in the control arm receive bilateral implantation of the same trifocal IOL model. Randomization occurs at the participant level, and both eyes follow the allocated intervention strategy. All assessments and follow-up visits proceed in parallel for both groups using standardized procedures.
| Arm | Type | Receives |
|---|---|---|
| Fusion EDOF IOL | Experimental | Device: Fusion EDOF IOL ImplantationParticipants undergo bilateral cataract surgery with contralateral implantation of two different extended-depth-of-focus intraocular lenses. The Mini Well IOL is implanted in the dominant eye and the Mini Well Proxa IOL in the non-dominant eye. This combined optical strategy is intended to provide continuous functional vision across distances while potentially reducing dysphotopsia by leveraging complementary lens designs. All procedures follow standardized surgical and postoperative protocols. |
| Bilateral Trifocal IOL | Active comparator | Device: Bilateral Trifocal IOL ImplantationParticipants undergo bilateral cataract surgery with implantation of the same trifocal intraocular lens, the FineVision POD F, in both eyes. The lens distributes light across distance, intermediate, and near focal points and represents a standard presbyopia-correcting approach. Surgical technique and postoperative management are consistent with those used in the experimental arm to ensure comparability. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18 years or older.
- Diagnosis of age-related cataract in both eyes requiring bilateral cataract surgery.
- Corneal astigmatism 0.50 diopters or less in each eye.
- No other media opacities except cataract.
- Regular corneal shape without abnormal curvature or high-order aberrations on topography/aberrometry.
Key exclusion criteria (8 listed)
- Any prior ocular surgery in either eye.
- Any concomitant ocular disease that could affect visual outcomes (for example glaucoma, retinal disease, significant macular pathology, corneal dystrophy or degeneration, keratoconus, significant dry eye not controlled with treatment).
- Clinically significant irregular astigmatism or corneal scarring.
- Any intraoperative complication during cataract surgery that could compromise IOL position or visual outcome (such as posterior capsule rupture, zonular dialysis); such eyes will be excluded from the analysis set.
- Significant posterior capsule opacification before the 3-month outcome visit requiring YAG capsulotomy.
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 |
|---|---|---|
| Fusion EDOF IOL ImplantationBilateral cataract extraction followed by implantation of two different extended-depth-of-focus intraocular lenses in opposite eyes. The dominant eye receives an EDOF lens based on wavefront-modulation optics (Mini Well), while the non-dominant eye receives a complementary EDOF lens optimized for near to intermediate performance (Mini Well Proxa). This contralateral design is intended to extend functional vision range and modulate dysphotopsia by combining distinct optical profiles within the same participant. | Device | Fusion EDOF IOL |
| Bilateral Trifocal IOL ImplantationBilateral cataract extraction followed by implantation of the same trifocal presbyopia-correcting intraocular lens in both eyes (FineVision POD F). This lens allocates light across three focal points-distance, intermediate, and near-representing a standard multifocal approa | Device | Bilateral Trifocal IOL |
Primary outcome
Objective halo area under binocular vision.
Time frame: 3 months post-second eye surgery.
Objective halo area under binocular vision, defined as the quantitative measurement of halo perception expressed as the total area (cm²) of the halo pattern surrounding a central light stimulus under binocular conditions, assessed 3 months after bilateral intraocular lens (IOL) implantation (3 months post-second eye surgery). Higher halo area values indicate more pronounced photic phenomena (worse halo disturbance), whereas lower values indicate fewer or less extensive halos (better outcome)
7 secondary outcomes
Uncorrected Distance Visual Acuity (UDVA)
Time frame: 1 and 3 months postoperatively.
Uncorrected Intermediate Visual Acuity (UIVA)
Time frame: 1 and 3 months postoperatively.
Uncorrected Near Visual Acuity (UNVA)
Time frame: 3 months postoperatively.
Contrast Sensitivity (CS)
Time frame: 3 months postoperatively.
Strehl Ratio
Time frame: 3 months postoperatively
Root Mean Square
Time frame: 3 months postoperatively
Quality of Life (NEI RQL-42 Score)
Time frame: 3 months postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Background: PubMed 35275002Pedrotti E, Neri E, Bonacci E, Barosco G, Galzignato A, Montresor A, Rodella A, De Gregorio A, Bosello F, Marchini G. Extended Depth of Focus Versus Monofocal IOLs in Patients With High Myopia: Objective and Subjective Visual Outcomes. J Refract Surg. 2022 Mar;38(3):158-166. doi: 10.3928/1081597X-20211220-01. Epub 2022 Mar 1.
- Background: PubMed 32267951Pedrotti E, Chierego C, Talli PM, Selvi F, Galzignato A, Neri E, Barosco G, Montresor A, Rodella A, Marchini G. Extended Depth of Focus Versus Monofocal IOLs: Objective and Subjective Visual Outcomes. J Refract Surg. 2020 Apr 1;36(4):214-222. doi: 10.3928/1081597X-20200212-01.
- Background: PubMed 29138533de Medeiros AL, de Araujo Rolim AG, Motta AFP, Ventura BV, Vilar C, Chaves MAPD, Carricondo PC, Hida WT. Comparison of visual outcomes after bilateral implantation of a diffractive trifocal intraocular lens and blended implantation of an extended depth of focus intraocular lens with a diffractive bifocal intraocular lens. Clin Ophthalmol. 2017 Oct 26;11:1911-1916. doi: 10.2147/OPTH.S145945. eCollection 2017.
- Background: PubMed 30627791Khandelwal SS, Jun JJ, Mak S, Booth MS, Shekelle PG. Effectiveness of multifocal and monofocal intraocular lenses for cataract surgery and lens replacement: a systematic review and meta-analysis. Graefes Arch Clin Exp Ophthalmol. 2019 May;257(5):863-875. doi: 10.1007/s00417-018-04218-6. Epub 2019 Jan 10.
- Background: PubMed 22972061Calladine D, Evans JR, Shah S, Leyland M. Multifocal versus monofocal intraocular lenses after cataract extraction. Cochrane Database Syst Rev. 2012 Sep 12;(9):CD003169. doi: 10.1002/14651858.CD003169.pub3.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data that underlie the main published results (including primary and secondary outcomes) will be shared. Data will be available beginning 12 months after publication of the primary manuscript and for 5 years thereafter. Data will be shared with qualified researchers for methods-sound proposals focused on cataract surgery, intraocular lenses, or visual outcomes, after approval by the sponsor and execution of a data use agreement. Requests should be sent to the corresponding investigator by email.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fusion EDOF IOL Implantation and Bilateral Trifocal IOL Implantation in people with Cataract and Presbyopia Correction, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.
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 9 inclusion and 8 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: finished, as of the sponsor's last update on 19 Dec 2025. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Objective halo area under binocular vision. (time frame: 3 months post-second eye surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07295119, which also lists 5 linked publications.
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 19 Dec 2025.