Bilateral Monofocal Versus Monofocal-EDOF IOL Implantation: Quality of Vision Comparison
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: cataract surgery.
- Who it may be relevant to
- Registry conditions: Cataract. Basic parameters: 50 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Overview
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
- Device cataract surgery
cataract surgery
Primary outcome measures
- Difference in binocular photopic distance corrected intermediate visual acuity between both groups using Radner chart. [Time frame: 3 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Termote K, Van Schoor R, Krolo I, Oellerich S, Cools W, Delbeke H, Ni Dhubhghaill S. Combination of a monofocal and one type of extended depth-of-focus (zonal refractive) intraocular lens (COMEDI) in bilateral cataract surgery protocol: a monocentric, randomised, parallel group trial in cataract surgery. BMJ Open Ophthalmol. 2024 Aug 5;9(1):e001572. doi: 10.1136/bmjophth-2023-001572. PMID 39103234
Identifiers
NCT: NCT06002399 · 23219_EDOF study