NCT06002399

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
4mo left

Started Nov 2023

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Nov 2023Sep 2026

First Submitted

Initial submission to the registry

August 15, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 21, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

October 10, 2023

Status Verified

August 1, 2023

Enrollment Period

2.8 years

First QC Date

August 15, 2023

Last Update Submit

October 4, 2023

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Bilateral monofocal intraocular lens

OTHER

Standard treatment

Device: cataract surgery

Monofocal and contralateral extended depth-of-focus intraocular lens

EXPERIMENTAL

Experimental treatment

Device: cataract surgery

Interventions

cataract surgeryDEVICE

cataract surgery

Bilateral monofocal intraocular lensMonofocal and contralateral extended depth-of-focus intraocular lens

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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: 39103234DERIVED

MeSH Terms

Conditions

Cataract

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Staff Member Ophthalmology

Study Record Dates

First Submitted

August 15, 2023

First Posted

August 21, 2023

Study Start

November 1, 2023

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

October 10, 2023

Record last verified: 2023-08