Extended Depth of Focus, Intraocular Implants
Conditions
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.
Interventions
OTHERQuestionnaires
NEI-VFQ (National Eye Institute Visual Function Questionnaire) 25 before the surgery, 3 months after and 6 months after the surgery.
OTHERIntermediate visual acuity
ETDRS (Early Treatment Diabetic Retinopathy Study) scale before the surgery and 1 month, 3 months and 6 months after the surgery
PROCEDUREOptical coherence tomography
1 month, 3 months and 6 months after surgery
PROCEDUREcataract surgery with intraocular lens implantation
Two different cataract surgeries : TECNIS monofocal versus PureSee EDOF (extended depth of focus)
Sponsors
Almaviva Sante
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distance visual acuity (4 m) | 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. |
Countries
France
Contacts
CONTACTJessica Delorme
Outcome results
None listed