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

NCT06737562 | Recruiting

• 1 other identifier: ASD_2023_5
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Cataract Bilateral; Bilateral Cataracts; Bilateral Cataract

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

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.

Procedure: Immediatly sequential bilateral cataract surgery

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.

Procedure: Delayed sequential bilateral cataract surgery

Interventions

Delayed sequential bilateral cataract surgery PROCEDURE

Delayed sequential bilateral cataract surgery : 3 weeks +/-1 week between the two procedures

DSBCS

Immediatly sequential bilateral cataract surgery PROCEDURE

Immediatly sequential bilateral cataract surgery

ISBCS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Women of childbearing age
• Surgery scheduled under general anesthesia or combined with other eye surgeries
• 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

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (4)

Chu Morvan

Brest, France

RECRUITING

Clinical Judge

Marseille, France

RECRUITING

Cochin Hospital

Paris, France

NOT YET RECRUITING

Fondation Ophtalmologique Adolphe de Rothschild

Paris, France

RECRUITING

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Central Study Contacts

Amelie Yavchitz

CONTACT

+33148036454; ayavchitz@for.paris

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: December 17, 2024
• Study Start: July 3, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2029
• Last Updated: December 3, 2025

Record last verified: 2025-12

Locations

FR (4)