Evaluation Of Patient Satisfaction And Quality Of Vision After EDOF Or Trifocal IOL Implantation

NCT07295119 | Completed

• 1 other identifier: 74253-12/12/2022
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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). 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:

1. 1.Experimental group: Mini Well lens in the dominant eye and Mini Well Proxa lens in the other eye.
2. 2.Comparison group: FineVision POD F lens in both eyes.

Conditions

Cataract; Presbyopia Correction

Keywords

EDOF IOL; Trifocal IOL; Halo perception; spectacle indipendente

Outcome Measures

Primary Outcomes (1)

• 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)

  3 months post-second eye surgery.

Secondary Outcomes (7)

• Uncorrected Distance Visual Acuity (UDVA)

  1 and 3 months postoperatively.

• Uncorrected Intermediate Visual Acuity (UIVA)

  1 and 3 months postoperatively.

• Uncorrected Near Visual Acuity (UNVA)

  3 months postoperatively.

• Contrast Sensitivity (CS)

  3 months postoperatively.

• Strehl Ratio

  3 months postoperatively

Study Arms (2)

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.

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.

Device: Bilateral Trifocal IOL Implantation

Interventions

Fusion EDOF IOL Implantation DEVICE

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.

Fusion EDOF IOL

Bilateral Trifocal IOL Implantation DEVICE

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

Bilateral Trifocal IOL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Integrata Verona: lead

Study Sites (1)

AOUI Verona

Verona, Verona, 37134, Italy

Location

Related Publications (5)

• 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.

  PMID: 35275002 BACKGROUND

• Pedrotti 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.

  PMID: 32267951 BACKGROUND

• de 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.

  PMID: 29138533 BACKGROUND

• Khandelwal 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.

  PMID: 30627791 BACKGROUND

• Calladine 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.

  PMID: 22972061 BACKGROUND

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants are masked to the intraocular lens (IOL) model implanted in each eye. Outcome assessors, including performing postoperative visual testing and halometry, remain masked to treatment allocation. Surgical staff cannot be masked due to required knowledge of lens type during the procedure. Postoperative data collection is structured to prevent assessors from accessing operative records or lens identifiers. Patients are instructed not to discuss perceived optical differences between eyes during masked assessments to preserve masking integrity.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Ophthalmology and Chairman Director, School of Ophthalmology Eye Clinic - Department of Surgery, Dentistry, Pediatrics and Gynecology

Model Details: 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.

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 19, 2025
• Study Start: April 24, 2023
• Primary Completion: November 13, 2024
• Study Completion: November 13, 2024
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Data will be available beginning 12 months after publication of the primary manuscript and for 5 years thereafter.
• Access Criteria: 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.

Locations

IT (1)