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

Not Applicable

Not yet recruiting

• Conditions: Cataract
• Interventions: Device: cataract surgery

• Registration Number: NCT06002399
• Lead Sponsor: Vrije Universiteit Brussel

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-08
• Study First Submitted: 2023-08-15
• Study First Submitted QC: 2023-08-15
• Study First Posted: 2023-08-21
• Last Update Submitted: 2023-10-04
• Last Update Posted: 2023-10-10
• Study Start: 2023-11
• Primary Completion: 2026-09
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Patients aged between 50 and 90 years with bilateral cataract without concomitant exclusion criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Monofocal and contralateral extended depth-of-focus intraocular lens	cataract surgery	Experimental treatment
Bilateral monofocal intraocular lens	cataract surgery	Standard treatment

Primary Outcome Measures

Name	Time	Method
Difference in binocular photopic distance corrected intermediate visual acuity between both groups using Radner chart.	3 months	Difference in binocular photopic distance corrected intermediate visual acuity between both groups using Radner chart.