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NCT Number: NCT07789249

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.<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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique du Val d'Ouest - Centre Pôle Vision, Aix-en-Provence, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

questionnaires

Other

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

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

Optical Coherence Tomography

Procedure

1 month, 3 months and 6 months after surgery

cataract surgery with intraocular lens implantation

Procedure

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

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica Delorme

CONTACT

[email protected]

00336 23 91 95 73

Sponsors and collaborators

Lead sponsor

Almaviva Sante

Other

Registry information

Official study 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

Acronym: MACAEDOF

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 27, 2026
Registry last updated
Aug 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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