About this trial
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 Surgeons (ISBCS) has issued a guide to best practice (the ''ISBCS General Principles for Excellence in ISBCS''), enabling surgery on both eyes to be performed on the same day in complete safety. As a result, Immediate Sequential Bilateral Cataract Surgery (ISBCS), which involves operating on both eyes on the same day, could be performed with no additional risk compared to SDBCS, while providing the same level of postoperative visual acuity. In view of these factors, we hypothesize that CCBIS would be an efficient alternative to DSBCS in cases of bilateral cataract, for the patient and his family, the hospital and the health insurance company. In addition, its adoption would reduce delays in access to treatment, thus promoting better access to care in the situation of growing demand for this treatment, particularly in areas with fewer medical facilities.
The aim of thisproject is to evaluate the associated costs and quality of life in comparison with CCBSD, based on a prospective, multicenter, randomized controlled trial.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 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
Trial design
Parallel
Treatments tested in this trial
Immediatly sequential bilateral cataract surgery
Procedure/SurgeryImmediatly sequential bilateral cataract surgery
Delayed sequential bilateral cataract surgery
Procedure/SurgeryDelayed sequential bilateral cataract surgery : 3 weeks +/-1 week between the two procedures
Treatment groups
Trial outcomes
Primary outcomes
Cost-utility of ISBCS compared to DSBCS
Incremental cost-utility ratio calculated 3 months after the index surgery (1st surgery in the case of DSBCS), from the collective perspective.
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