Quality of Vision After Implantation of EDOF Implants Versus Monofocal Implants in Patients Who Underwent Epiretinal Membrane and Cataract Surgery (MACAEDOF)
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
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jessica Delorme
- Phone Number: 00336 23 91 95 73
- Email: jessica.delorme@almaviva-sante.com
Study Locations
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-
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Aix-en-Provence, France, 13097
- Clinique du Val d'Ouest - Centre Pôle Vision
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Contact:
- Sébastien Guigou
- Phone Number: 0033442992150
- Email: rdv@aixvision.fr
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Marseille, France, 13008
- Centre Monticelli Paradis
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Contact:
- Frédéric MATONTI, Dr
- Phone Number: 00336 23 86 69 46
- Email: frederic.matonti@free.fr
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Écully, France, 69130
- Clinique du Val d'Ouest - Centre Pôle Vision
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Contact:
- Pierre-Loïc Cornut
- Phone Number: 0033478356969
- Email: jessica.delorme@almaviva-sante.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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 |
Intervention / Treatment |
|---|---|
|
Experimental: Implants EDOF
|
NEI-VFQ (National Eye Institute Visual Function Questionnaire) 25 before the surgery, 3 months after and 6 months after the surgery.
ETDRS (Early Treatment Diabetic Retinopathy Study) scale before the surgery and 1 month, 3 months and 6 months after the surgery
1 month, 3 months and 6 months after surgery
Two different cataract surgeries : TECNIS monofocal versus PureSee EDOF (extended depth of focus)
|
|
Active Comparator: Monofocal implants
|
NEI-VFQ (National Eye Institute Visual Function Questionnaire) 25 before the surgery, 3 months after and 6 months after the surgery.
ETDRS (Early Treatment Diabetic Retinopathy Study) scale before the surgery and 1 month, 3 months and 6 months after the surgery
1 month, 3 months and 6 months after surgery
Two different cataract surgeries : TECNIS monofocal versus PureSee EDOF (extended depth of focus)
|
What is the study measuring?
Primary Outcome Measures
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
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Diagnostic Techniques and Procedures
- Diagnosis
- Surgical Procedures, Operative
- Data Collection
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Ophthalmologic Surgical Procedures
- Tomography
- Diagnostic Imaging
- Tomography, Optical
- Optical Imaging
- Refractive Surgical Procedures
- Surveys and Questionnaires
- Tomography, Optical Coherence
- Cataract Extraction
- Lens Implantation, Intraocular
Other Study ID Numbers
- 2025-A02106-43
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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