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

V

Vrije Universiteit Brussel

Status

Not yet enrolling

Conditions

Cataract

Treatments

Device: cataract surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT06002399
23219_EDOF study

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Ages

50 to 90 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

80 participants in 2 patient groups

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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