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

Study acronym: SIMCAT
StatusRecruiting
PhaseNot applicable
Started2025-07-03
View on ClinicalTrials.gov ↗

Amendment history

2025-12-02
notable
Not Yet Recruiting→Recruiting Study Status, Oversight, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2028-06→2028-07
Completion date2028-06→2029-07
Start dateestimated 2025-06→confirmed 2025-07-03
Study sites0→4
2025-05-19
minor
Study Identification, Study Status, Study Design v2
PhasePhase 3→Not applicable
Primary completion date2027-11→2028-06
Completion date2027-11→2028-06
Start date2025-02→2025-06
Study titlerevised
Medico-economic Evaluation of Immediately Sequential Bilateral Cataract Surgery Compared withWith Delayed Sequential Cataract Surgery in France
2024-12-18
minor
Study Status, Study Description, Outcome Measures v1
Re-verified, no change to tracked fields
2024-12-12
minor
Original filing
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.
Trial Details
NCT Number NCT06737562
Lead Sponsor Fondation Ophtalmologique Adolphe de Rothschild
Conditions Cataract Bilateral, Bilateral Cataracts, Bilateral Cataract
Enrollment 242 participants
Start Date 2025-07-03
Primary Completion 2028-07 (estimated)
Study Completion 2029-07 (estimated)
Updated on ClinicalTrials.gov 2025-12-03