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NCT Number: NCT06002399

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

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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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cataract surgery

Device

cataract surgery

Primary outcomes

  1. Difference in binocular photopic distance corrected intermediate visual acuity between both groups using Radner chart.

    Time frame: 3 months

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

Sponsors and collaborators

Lead sponsor

Vrije Universiteit Brussel

Other

Registry information

Official study title

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

Acronym: COMEDI

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 21, 2023
Registry last updated
Oct 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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