questionnaires
OtherNEI-VFQ (National Eye Institute Visual Function Questionnaire) 25 before the surgery, 3 months after and 6 months after the surgery.
NCT Number: NCT07789249
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Clinique du Val d'Ouest - Centre Pôle Vision, Aix-en-Provence, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
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.
Contact information is provided by the study sponsor or research team.
Almaviva Sante
Other
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
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.
Published trials that share one or more normalized conditions with this study.
NCT07051720
Behavior, Cataract
Ahaus, North Rhine-Westphalia, Germany
View Trial DetailsNCT04865016
Extended Depth of Focus, Multifocal Intraocular Lenses
Istanbul, Turkey (Türkiye)
View Trial Details