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.
Studienübersicht
Status
Bedingungen
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Jessica Delorme
- Telefonnummer: 00336 23 91 95 73
- E-Mail: jessica.delorme@almaviva-sante.com
Studienorte
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Aix-en-Provence, Frankreich, 13097
- Clinique du Val d'Ouest - Centre Pôle Vision
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Kontakt:
- Sébastien Guigou
- Telefonnummer: 0033442992150
- E-Mail: rdv@aixvision.fr
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Marseille, Frankreich, 13008
- Centre Monticelli Paradis
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Kontakt:
- Frédéric MATONTI, Dr
- Telefonnummer: 00336 23 86 69 46
- E-Mail: frederic.matonti@free.fr
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Écully, Frankreich, 69130
- Clinique du Val d'Ouest - Centre Pôle Vision
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Kontakt:
- Pierre-Loïc Cornut
- Telefonnummer: 0033478356969
- E-Mail: jessica.delorme@almaviva-sante.com
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Sonstiges
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: Implants EDOF
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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)
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Aktiver Komparator: Monofocal implants
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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)
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Distance visual acuity (4 m)
Zeitfenster: 3 months
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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
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Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Qualität, Zugang und Bewertung im Gesundheitswesen
- Untersuchungstechniken
- Epidemiologische Methoden
- Diagnosetechniken und Verfahren
- Diagnose
- Chirurgische Eingriffe, operativ
- Datenerfassung
- Gesundheitsbewertungsmechanismen
- Qualität der Gesundheitsversorgung
- Öffentliche Gesundheit
- Umwelt und öffentliche Gesundheit
- Ophthalmologische chirurgische Eingriffe
- Tomographie
- Diagnostische Bildgebung
- Tomographie, optisch
- Optische Bildgebung
- Refraktive chirurgische Verfahren
- Umfragen und Fragebögen
- Tomographie, optische Kohärenz
- Kataraktextraktion
- Linsenimplantation, intraokular
Andere Studien-ID-Nummern
- 2025-A02106-43
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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