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

Sponsor

Vrije Universiteit Brussel (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06002399

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cataract	Device: cataract surgery	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

82 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Combining a Monofocal With an EDOF IOL: Is There an Improvement in Quality of Vision After Cataract Surgery Over Bilateral Monofocal IOL Implantation.

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2026

Anticipated Study Completion Date :

Sep 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Other: Bilateral monofocal intraocular lens Standard treatment	Device: cataract surgery cataract surgery
Experimental: Monofocal and contralateral extended depth-of-focus intraocular lens Experimental treatment	Device: cataract surgery cataract surgery

Arm

Intervention/Treatment

Other: Bilateral monofocal intraocular lens

Standard treatment

Device: cataract surgery

cataract surgery

Experimental: Monofocal and contralateral extended depth-of-focus intraocular lens

Experimental treatment

Device: cataract surgery

cataract surgery

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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 0.75D
prior ocular surgery in the last six months
patients with prior unilateral cataract surgery

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Vrije Universiteit Brussel

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Karolien Termote, MD FEBOpht, MD FEBOpht, Vrije Universiteit Brussel

ClinicalTrials.gov Identifier:

NCT06002399

Other Study ID Numbers:

23219_EDOF study

First Posted:

Aug 21, 2023

Last Update Posted:

Aug 21, 2023

Last Verified:

Aug 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cataract

Study Results

No Results Posted as of Aug 21, 2023