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

Cataract Clinical Trial

— 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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06002399
• Other study ID #: 23219_EDOF study
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2023
• Est. completion date: September 2026

Study information

• Verified date: August 2023
• Source: Vrije Universiteit Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: September 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• cataract surgery
cataract surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vrije Universiteit Brussel

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months