CataractCOMEDINCT06002399
Bilateral Monofocal Versus Monofocal-EDOF IOL Implantation: Quality of Vision Comparison
A study testing cataract surgery in people with Cataract, run by Vrije Universiteit Brussel at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 50 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Cataract
- What is being tested?
- cataract surgery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- 10 Nov 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged between 50 and 90 years with bilateral cataract without concomitant exclusion criteria
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
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?
Read more
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.
- Conditions
- Cataract
- Being tested
- cataract surgery
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cataract surgeryDevice
cataract surgery
| Study group | Role | What they receive |
|---|---|---|
| Bilateral monofocal intraocular lens | Other | Standard treatment Receives: Device: cataract surgery |
| Monofocal and contralateral extended depth-of-focus intraocular lens | Experimental | Experimental treatment Receives: Device: cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start10 Nov 2023
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CataractStudies of the same condition, open and under way.
- More trials run by Vrije Universiteit BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karolien Termote, MD FEBOpht, Vrije Universiteit Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06002399
- Sponsor's protocol ID
- 23219_EDOF study
- Acronym
- COMEDI
- Status last verified
- Aug 2026
- First submitted
- 15 Aug 2023
- Last updated
- 27 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 39103234
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06002399
- Acronym / sponsor ID
- COMEDI / 23219_EDOF study
- Conditions
- Cataract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Study start
- 10 Nov 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bilateral monofocal intraocular lens | Other | Device: cataract surgeryStandard treatment |
| Monofocal and contralateral extended depth-of-focus intraocular lens | Experimental | Device: cataract surgeryExperimental treatment |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged between 50 and 90 years with bilateral cataract without concomitant exclusion criteria
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cataract surgerycataract surgery | Device | Bilateral monofocal intraocular lens, Monofocal and contralateral extended depth-of-focus intraocular lens |
Primary outcome
Difference in binocular photopic distance corrected intermediate visual acuity between both groups using Radner chart.
Time frame: 3 months
Difference in binocular photopic distance corrected intermediate visual acuity between both groups using Radner chart.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Derived from this study: PubMed 39103234Termote 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cataract surgery in people with Cataract, run by Vrije Universiteit Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in binocular photopic distance corrected intermediate visual acuity between both groups using Radner chart. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06002399, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.