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

RecruitingNAAges 18 Years - anyAllFondation Ophtalmologique Adolphe de Rothschild
NCT06737562 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Cataracts are defined as opacification of all or part of the crystalline lens, resulting in reduced vision. It is a common disease in France, affecting more than one in five people over the age of 65, and almost two in three over the age of 85. Cataract treatment is exclusively surgical. In the case of bilateral cataracts, which account for 70% of cases, Delayed Sequential Bilateral Cataract Surgery (DSBCS), which involves operating on both eyes with an interval of a few weeks, is the reference treatment in France. The practice of DSBCS has long been justified by the need to reduce the risk of post-operative complications, essentially refractive error and bilateral endophthalmitis. Today, thanks to numerous technological advances in cataract surgery and new intraoperative standards, these complications have become exceptional. Since 2009, the International Society of Bilateral Cataract S

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📋 Eligibility rules (as published)
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
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What it tests

  • Immediatly sequential bilateral cataract surgery
  • Delayed sequential bilateral cataract surgery
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Where

4 sites
Chu Morvan
Brest, France
Clinical Judge
Marseille, France
Cochin Hospital
Paris, France
Fondation Ophtalmologique Adolphe de Rothschild
Paris, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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