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

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. Experimental group: Mini Well lens in the dominant eye and Mini Well Proxa lens in the other eye.
2. 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.

Conditions

• Cataract
• Presbyopia Correction

Interventions

DEVICE

Fusion EDOF IOL Implantation

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.

DEVICE

Bilateral Trifocal IOL Implantation

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

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Integrata Verona

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-04-24

Primary Completion

2024-11-13

Completion

2024-11-13

Countries

• Italy

Study Locations