Medico-economic Evaluation of Immediately Sequential Bilateral Cataract Surgery Compared With Delayed Sequential Cataract Surgery in France: a Multicenter Randomized Controlled Trial

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Chu Morvan
RECRUITING
Brest
Clinical Judge
RECRUITING
Marseille
Cochin Hospital
NOT_YET_RECRUITING
Paris
Fondation Ophtalmologique Adolphe de Rothschild
RECRUITING
Paris
Contact Information
Primary
Amelie Yavchitz
ayavchitz@for.paris
+33148036454
Time Frame
Start Date: 2025-07-03
Estimated Completion Date: 2029-07
Participants
Target number of participants: 242
Treatments
Experimental: ISBCS
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.
Active_comparator: DSBCS
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.
Sponsors
Leads: Fondation Ophtalmologique Adolphe de Rothschild

This content was sourced from clinicaltrials.gov