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

Primary Purpose

Cataract

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
cataract surgery
Sponsored by
Vrije Universiteit Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Experimental

    Arm Label

    Bilateral monofocal intraocular lens

    Monofocal and contralateral extended depth-of-focus intraocular lens

    Arm Description

    Standard treatment

    Experimental treatment

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    August 15, 2023
    Last Updated
    October 4, 2023
    Sponsor
    Vrije Universiteit Brussel
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06002399
    Brief Title
    Bilateral Monofocal Versus Monofocal-EDOF IOL Implantation: Quality of Vision Comparison
    Acronym
    COMEDI
    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.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2023 (Anticipated)
    Primary Completion Date
    September 2026 (Anticipated)
    Study Completion Date
    September 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Vrije Universiteit Brussel

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cataract

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Bilateral monofocal intraocular lens
    Arm Type
    Other
    Arm Description
    Standard treatment
    Arm Title
    Monofocal and contralateral extended depth-of-focus intraocular lens
    Arm Type
    Experimental
    Arm Description
    Experimental treatment
    Intervention Type
    Device
    Intervention Name(s)
    cataract surgery
    Intervention Description
    cataract surgery
    Primary Outcome Measure Information:
    Title
    Difference in binocular photopic distance corrected intermediate visual acuity between both groups using Radner chart.
    Description
    Difference in binocular photopic distance corrected intermediate visual acuity between both groups using Radner chart.
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

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

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