Bilateral Monofocal Versus Monofocal-EDOF IOL Implantation: Quality of Vision Comparison

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-30

Study Completion Date

2026-09-30

Brief Summary

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The goal of this clinical trial is to compare visual quality after cataract surgery between two groups: bilateral monofocal intraocular lenses (IOL) and monofocal and contralateral extended depth-of-focus (EDOF) IOL implantation. The main question it aims to answer is:

• does the combination of both monofocal and EDOF IOLs presents an advantage over bilateral monofocal IOL implantation in the daily life of patients undergoing cataract surgery without the disadvantages of bilateral EDOF IOL implantation?

Participants will:

* be randomised in either bilateral monofocal group or monofocal and EDOF group
* undergo visual acuity testing with and without correction at all distances
* be asked to complete a quality of vision questionnaire
* undergo non-invasive examinations to measure residual astigmatism, contrast sensitivity, straylight, optical aberrations, reading spead.

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Detailed Description

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Conditions

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Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Bilateral monofocal intraocular lens

Standard treatment

Group Type OTHER

cataract surgery

Intervention Type DEVICE

cataract surgery

Monofocal and contralateral extended depth-of-focus intraocular lens

Experimental treatment

Group Type EXPERIMENTAL

cataract surgery

Intervention Type DEVICE

cataract surgery

Interventions

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cataract surgery

Intervention Type DEVICE

Eligibility Criteria

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Exclusion Criteria

* prior refractive surgery
* patients with corneal opacities, retinopathy, opticopathy, glaucoma, uveitis and amblyopia
* patients with corneal astigmatism greater than 3 diopters (D)
* patients with expected postoperative astigmatism higher than 0.50D
* prior ocular surgery in the last six months
* patients with prior unilateral cataract surgery

Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes