Immediate versus delayed bilateral cataract surgery in France

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Chu Morvan
  Brest, France Recruiting
• Clinical Judge
  Marseille, France Recruiting
• Fondation Ophtalmologique Adolphe de Rothschild
  Paris, France Recruiting
• Cochin Hospital
  Paris, France Not yet recruiting

Study contacts

• Study coordinator: Amelie Yavchitz
• Email: ayavchitz@for.paris
• Phone: +33148036454

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.