Immediate versus delayed bilateral cataract surgery in France
Medico-economic Evaluation of Immediately Sequential Bilateral Cataract Surgery Compared With Delayed Sequential Cataract Surgery in France: a Multicenter Randomized Controlled Trial
This study will test whether doing cataract surgery on both eyes the same day is as safe and cost-effective as doing the two operations on separate days for adults in France with cataracts in both eyes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 242 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondation Ophtalmologique Adolphe de Rothschild Research network |
| Locations | 4 sites (Brest and 3 other locations) |
| Trial ID | NCT06737562 on ClinicalTrials.gov |
What this trial studies
This interventional medico-economic trial compares immediate sequential bilateral cataract surgery (both eyes operated the same day) with delayed sequential bilateral cataract surgery (operations separated by weeks) in adult outpatients in France. Eligible participants are adults scheduled for non-combined cataract surgery under local anesthesia who can speak French, have a caregiver available on the day of surgery and the day after, and are resident in France. The study will collect data on healthcare costs, postoperative complications including refractive outcomes and endophthalmitis, and visual/refractive results over the postoperative period. Procedures are performed at multiple French ophthalmology centers following contemporary intraoperative standards and ISBCS guidance.
Who should consider this trial
Good fit: Adults in France with bilateral cataracts scheduled for outpatient cataract surgery under local anesthesia who speak French, have a caregiver available, and do not have the listed ocular risk factors are ideal candidates.
Not a fit: Patients with high-risk ocular features (for example keratoconus, extreme axial length, prior corneal surgery), active ocular infection, need for general anesthesia, or combined eye procedures are unlikely to receive benefit from same-day bilateral surgery.
Why it matters
Potential benefit: If successful, this approach could shorten the treatment timeline, reduce travel and healthcare costs, and make recovery more convenient for patients with bilateral cataracts.
How similar studies have performed: Previous reports and the ISBCS guidance since 2009 indicate same-day bilateral cataract surgery can be safe and cost-saving in carefully selected patients, although adoption varies by region.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 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
Where this trial is running
Brest and 3 other locations
- 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)
Study contacts
- Study coordinator: Amelie Yavchitz
- Email: ayavchitz@for.paris
- Phone: +33148036454
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.