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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ISBCS | Experimental | Both eyes will be operated on during the same surgical procedure. Surgery will be performed in accordance with the iSBCS (International Society of Bilateral Cataract Surgeons) General Principles for Excellence in ISBCS (Immediate Sequential Bilateral Cataract Surgery) [12] by investigating ophthalmic surgeons or co-investigators with at least two years' experience in cataract surgery. |
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| DSBCS | Active Comparator | Only one eye will be operated on during the first surgiczal procedure. The second eye will be operated on during a second surgical procdure delayed from 3 weeks +/- 1 week. Surgeries will be performed according to current guidelines by investigating or co-investigating ophthalmic surgeons with at least two years' experience in cataract surgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immediatly sequential bilateral cataract surgery | Procedure | Immediatly sequential bilateral cataract surgery |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months after index surgery (bilateral or on the first eye) |
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Inclusion Criteria:
Exclusion Criteria:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amelie Yavchitz | Contact | +33148036454 | ayavchitz@for.paris |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Morvan | Recruiting | Brest | France |
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| Delayed sequential bilateral cataract surgery | Procedure | Delayed sequential bilateral cataract surgery : 3 weeks +/-1 week between the two procedures |
|
| Clinical Judge | Recruiting | Marseille | France |
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| Cochin Hospital | Not yet recruiting | Paris | France |
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| Fondation Ophtalmologique Adolphe de Rothschild | Recruiting | Paris | France |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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