Quality of Vision After Implantation of EDOF Implants Versus Monofocal Implants in Patients Who Underwent Epiretinal Membrane and Cataract Surgery (MACAEDOF)

August 25, 2026 updated by: Almaviva Sante

A Prospective, Randomized Study Evaluating the Quality of Vision After Implantation of EDOF Implants Versus Monofocal Implants in Patients Who Underwent Epiretinal Membrane and Cataract Surgery

Phacoexistence, the first surgical procedure performed in France, naturally raises the question of lens replacement. In recent years, the choice of intraocular lenses has expanded considerably. The term EDOF (Extended Depth of Focus) refers to intraocular lenses offering an extended depth of field to improve vision at different distances, while reducing the visual aberrations associated with traditional multifocal lenses.

However, they still generate some optical aberrations that could therefore limit the quality of vision for patients with retinal damage.

With the development and acceleration of cataractogenic processes observed after vitrectomy, the use of combined phaco-vitrectomy surgery has become increasingly common, particularly among patients over 60 years of age. This integrated approach allows for the simultaneous treatment of cataracts and vitreoretinal pathologies, thus reducing the need for subsequent cataract surgery, which frequently develops after vitrectomy. In addition to optimizing the patient care pathway, this technique offers clinical advantages, such as faster visual recovery and fewer complications associated with multiple surgeries. Phacovitrectomy is therefore emerging as a practical and effective solution for managing elderly patients requiring vitreoretinal surgery.

Therefore, in the specific context of macular surgery, often considered less suitable for the use of premium implants, EDOF (Extended Depth of Focus) implants raise some questions. The available data on their performance and tolerability in this specific context remain limited, making their use still poorly defined in these complex clinical situations, except in certain medical macular pathologies.4 This study aims to evaluate, within the context of macular surgery, the relevance and potential role of EDOF (Extended Depth of Focus) implants in order to improve the management of these patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Aix-en-Provence, France, 13097
        • Clinique du Val d'Ouest - Centre Pôle Vision
        • Contact:
      • Marseille, France, 13008
        • Centre Monticelli Paradis
        • Contact:
      • Écully, France, 69130

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male or female over 18 years of age
  • Epiretinal membrane with surgical indication
  • Indication for cataract surgery with intraocular lens implantation
  • Epiretinal membranes with near visual acuity ≥ P4
  • Preserved ellipsoidal zone in the retrofoveal region, without fragmentation or interruption
  • Central macular thickness less than or equal to 450 microns
  • Signed informed consent
  • Patients covered by social security or an equivalent scheme

Exclusion Criteria:

  • Associated ocular pathologies (advanced glaucoma, exudative AMD).
  • Central macular thickness > 450 microns
  • Epiretinal membranes with near visual acuity < P4
  • Previous macular surgery
  • Contraindication to the implantation of either type of lens
  • Cognitive impairment, or a disorder causing difficulty understanding instructions or answering questionnaires
  • Pregnant, parturient, or breastfeeding women, as defined in Article L1121-5 of the French Public Health Code (CSP)
  • Protected individuals: adults under guardianship, curatorship, or other legal protection, deprived of liberty by judicial or administrative decision.
  • Patients incapable of personally giving consent, as defined in Article L.1121-8 of the French Public Health Code (CSP), or adults protected by law

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Implants EDOF
Other: Questionnaires
NEI-VFQ (National Eye Institute Visual Function Questionnaire) 25 before the surgery, 3 months after and 6 months after the surgery.
Other: Intermediate visual acuity
ETDRS (Early Treatment Diabetic Retinopathy Study) scale before the surgery and 1 month, 3 months and 6 months after the surgery
Procedure: Optical coherence tomography
1 month, 3 months and 6 months after surgery
Procedure: cataract surgery with intraocular lens implantation
Two different cataract surgeries : TECNIS monofocal versus PureSee EDOF (extended depth of focus)
Active Comparator: Monofocal implants
Other: Questionnaires
NEI-VFQ (National Eye Institute Visual Function Questionnaire) 25 before the surgery, 3 months after and 6 months after the surgery.
Other: Intermediate visual acuity
ETDRS (Early Treatment Diabetic Retinopathy Study) scale before the surgery and 1 month, 3 months and 6 months after the surgery
Procedure: Optical coherence tomography
1 month, 3 months and 6 months after surgery
Procedure: cataract surgery with intraocular lens implantation
Two different cataract surgeries : TECNIS monofocal versus PureSee EDOF (extended depth of focus)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Distance visual acuity (4 m)
Time Frame: 3 months

Distance visual acuity (4 m) using the ETDRS (Early Treatment Diabetic Retinopathy Study) scale at 3 months.

This involves asking the patient, positioned 4 meters away, to read a chart made up of 5 letters per line, with the size gradually decreasing from top to bottom. The score is determined by counting the number of letters read correctly (each letter is worth 1 point). The maximum score is 100 to 110 letters depending on the version.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Almaviva Sante

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 20, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 20, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 20, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 3, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025-A02106-43

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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