Medico-economic Evaluation of Immediately Sequential Bilateral Cataract Surgery Compared With Delayed Sequential Cataract Surgery in France

Launched by FONDATION OPHTALMOLOGIQUE ADOLPHE DE ROTHSCHILD · Dec 12, 2024

Keywords

ClinConnect Summary

This clinical trial is studying two different methods of cataract surgery for patients who need surgery on both eyes. The trial compares Immediate Sequential Bilateral Cataract Surgery (ISBCS), where both eyes are operated on the same day, to the standard method called Delayed Sequential Bilateral Cataract Surgery (DSBCS), where surgery is done on one eye followed by a wait of a few weeks before operating on the other eye. Researchers want to see if ISBCS is just as safe and effective as DSBCS and if it can provide better access to treatment for patients, especially in areas with fewer medical facilities.

To participate in this trial, you need to be at least 18 years old, living in France, and scheduled for cataract surgery on both eyes under local anesthesia. You should also have a caregiver who can help you on the day of surgery and the following day. It’s important that you understand and can speak French, and you need to agree to take part in the study. If you have certain eye conditions or health issues, you may not be eligible. Participants will have the opportunity to contribute to research that could improve cataract surgery options for many people in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age greater than or equal to 18 years
• • Indication for non-combined cataract surgery under local anaesthesia in both eyes
• • Patient scheduled for outpatient cataract surgery
• • Availability of a caregiver/accompanying person on the day of surgery and for the 1st day post-surgery
• • Resident in France
• • Speak and understand French
• • Consent to participate in the study
• • Affiliated or beneficiary of social security
• Exclusion Criteria:
• • Women of childbearing age
• • Surgery scheduled under general anesthesia or combined with other eye surgeries
• • Ocular tone \> 24 mm Hg in at least one eye on day of inclusion
• * Presence of risk factors for refractive error :
• • Presence of keratoconus confirmed by corneal topography Extreme axial eye length (\< 21 mm or \> 27 mm) High myopia with posterior staphyloma History of corneal surgery (LASIK, surface laser, radial keratotomy)
• • - Presence of risk factors for endophthalmitis : Ocular, periocular or adnexal infections Immunosuppression Uncontrolled diabetes
• • Presence of risk factors for intraoperative complications Ocular, adnexal or anatomical abnormalities History of retinal detachment Lens dislocation or iridodonesis Black cataract or posterior polar cataract History of perforating or blunt ocular trauma
• • Presence of risk factors for corneal edema (e.g. Fuchs' endothelial dystrophy)
• • Presence of vision-related comorbidities (glaucoma, AMD, amblyopia, uveitis, etc.)
• • Presence of diabetes with diabetic retinopathy or macular edema
• • Patient unable to participate in follow-up (e.g., response to questionnaires)
• • Presence of cognitive disorders that could affect the smooth running of surgery or response to questionnaires