Intraocular ImplantsMACAEDOFNCT07789249
Quality of Vision After Implantation of EDOF Implants Versus Monofocal Implants in Patients Who Underwent Epiretinal Membrane and Cataract Surgery
A study testing Questionnaires, Intermediate visual acuity and Optical coherence tomography in people with Intraocular Implants and Extended Depth of Focus, run by Almaviva Sante at 3 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intraocular Implants, Extended Depth of Focus
- What is being tested?
- Questionnaires, Intermediate visual acuity and Optical coherence tomography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesFrance
- Study dates
- 20 Sep 2026to 20 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites
Clinique du Val d'Ouest - Centre Pôle Vision
Aix-en-Provence, 13097
Sébastien Guigou, 0033442992150, rdv@aixvision.fr
Clinique du Val d'Ouest - Centre Pôle Vision
Écully, 69130
Pierre-Loïc Cornut, 0033478356969, jessica.delorme@almaviva-sante.com
Centre Monticelli Paradis
Marseille, 13008
Frédéric MATONTI, Dr, 00336 23 86 69 46, frederic.matonti@free.fr
About this study
Official title: 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.
Read more
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.<sup>4</sup> 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.
- Conditions
- Intraocular Implants, Extended Depth of Focus
- Being tested
- Questionnaires, Intermediate visual acuity, Optical coherence tomography, cataract surgery with intraocular lens implantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
NEI-VFQ (National Eye Institute Visual Function Questionnaire) 25 before the surgery, 3 months after and 6 months after the surgery.
Intermediate visual acuityOther
ETDRS (Early Treatment Diabetic Retinopathy Study) scale before the surgery and 1 month, 3 months and 6 months after the surgery
Optical coherence tomographyProcedure or surgery
1 month, 3 months and 6 months after surgery
cataract surgery with intraocular lens implantationProcedure or surgery
Two different cataract surgeries : TECNIS monofocal versus PureSee EDOF (extended depth of focus)
| Study group | Role | What they receive |
|---|---|---|
| Implants EDOF | Experimental | Not described Receives: Other: Questionnaires; Other: Intermediate visual acuity; Procedure: Optical coherence tomography; Procedure: cataract surgery with intraocular lens implantation |
| Monofocal implants | Active comparator | Not described Receives: Other: Questionnaires; Other: Intermediate visual acuity; Procedure: Optical coherence tomography; Procedure: cataract surgery with intraocular lens implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance visual acuity (4 m)
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.
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 posted27 Aug 2026
- Study start20 Sep 2026 (estimated)
- Primary completion20 Dec 2028 (estimated)
- Study completion20 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraocular ImplantsStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Almaviva Sante
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07789249
- Sponsor's protocol ID
- 2025-A02106-43
- Acronym
- MACAEDOF
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
- 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
- ClinicalTrials.gov ID
- NCT07789249
- Acronym / sponsor ID
- MACAEDOF / 2025-A02106-43
- Conditions
- Intraocular Implants, Extended Depth of Focus
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Almaviva SanteUniversity, hospital or other
- Study start
- 20 Sep 2026 (estimated)
- Primary completion
- 20 Dec 2028 (estimated)
- Study completion
- 20 Dec 2028 (estimated)
- First posted
- 27 Aug 2026 (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.
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.<sup>4</sup> 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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Implants EDOF | Experimental | Other: Questionnaires, Other: Intermediate visual acuity, Procedure: Optical coherence tomography, Procedure: cataract surgery with intraocular lens implantation |
| Monofocal implants | Active comparator | Other: Questionnaires, Other: Intermediate visual acuity, Procedure: Optical coherence tomography, Procedure: cataract surgery with intraocular lens implantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| QuestionnairesNEI-VFQ (National Eye Institute Visual Function Questionnaire) 25 before the surgery, 3 months after and 6 months after the surgery. | Other | Implants EDOF, Monofocal implants |
| Intermediate visual acuityETDRS (Early Treatment Diabetic Retinopathy Study) scale before the surgery and 1 month, 3 months and 6 months after the surgery | Other | Implants EDOF, Monofocal implants |
| Optical coherence tomography1 month, 3 months and 6 months after surgery | Procedure or surgery | Implants EDOF, Monofocal implants |
| cataract surgery with intraocular lens implantationTwo different cataract surgeries : TECNIS monofocal versus PureSee EDOF (extended depth of focus) | Procedure or surgery | Implants EDOF, Monofocal implants |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaires, Intermediate visual acuity and Optical coherence tomography in people with Intraocular Implants and Extended Depth of Focus, run by Almaviva Sante at 3 sites in France.
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 8 inclusion and 9 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: opening soon, 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 3 sites in France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica Delorme (00336 23 91 95 73, jessica.delorme@almaviva-sante.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distance visual acuity (4 m) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.