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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06002399
Acronym
COMEDI
Enrollment
50
Registered
2023-08-21
Start date
2023-11-10
Completion date
2025-12-31
Last updated
2026-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

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.

Interventions

DEVICEcataract surgery

cataract surgery

Sponsors

Vrije Universiteit Brussel
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
Yes

Inclusion criteria

* Patients aged between 50 and 90 years with bilateral cataract without concomitant

Design outcomes

Primary

MeasureTime frameDescription
Difference in binocular photopic distance corrected intermediate visual acuity between both groups using Radner chart.3 monthsDifference in binocular photopic distance corrected intermediate visual acuity between both groups using Radner chart.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 28, 2026