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

NCT07789249 | Not Yet Recruiting

• 1 other identifier: 2025-A02106-43
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

Brief 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. 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.

Conditions

Intraocular Implants; Extended Depth of Focus

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Study Arms (2)

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

Interventions

Questionnaires OTHER

NEI-VFQ (National Eye Institute Visual Function Questionnaire) 25 before the surgery, 3 months after and 6 months after the surgery.

Implants EDOF; Monofocal implants

Intermediate visual acuity OTHER

ETDRS (Early Treatment Diabetic Retinopathy Study) scale before the surgery and 1 month, 3 months and 6 months after the surgery

Implants EDOF; Monofocal implants

Optical coherence tomography PROCEDURE

1 month, 3 months and 6 months after surgery

Implants EDOF; Monofocal implants

cataract surgery with intraocular lens implantation PROCEDURE

Two different cataract surgeries : TECNIS monofocal versus PureSee EDOF (extended depth of focus)

Implants EDOF; Monofocal implants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Almaviva Sante: lead

Study Sites (3)

Clinique du Val d'Ouest - Centre Pôle Vision

Aix-en-Provence, 13097, France

Location

Clinique du Val d'Ouest - Centre Pôle Vision

Écully, 69130, France

Location

Centre Monticelli Paradis

Marseille, 13008, France

Location

MeSH Terms

Interventions

Surveys and Questionnaires; Tomography, Optical Coherence; Cataract Extraction; Lens Implantation, Intraocular

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Jessica Delorme

CONTACT

00336 23 91 95 73; jessica.delorme@almaviva-sante.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2026
• First Posted: August 27, 2026
• Study Start (Estimated): September 20, 2026
• Primary Completion (Estimated): December 20, 2028
• Study Completion (Estimated): December 20, 2028
• Last Updated: August 27, 2026

Record last verified: 2026-08

Locations

FR (3)