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NCT Number: NCT06737562

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

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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Key information

Conditions

Cataract Bilateral Bilateral Cataract Bilateral Cataracts Cataract Eye Diseases Lens Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Morvan, Brest, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Immediatly sequential bilateral cataract surgery

Procedure

Immediatly sequential bilateral cataract surgery

Delayed sequential bilateral cataract surgery

Procedure

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

Primary outcomes

Cost-utility of ISBCS compared to DSBCS

Time frame: 3 months after index surgery (bilateral or on the first eye)

Incremental cost-utility ratio calculated 3 months after the index surgery (1st surgery in the case of DSBCS), from the collective perspective.

Study contacts

Contact information is provided by the study sponsor or research team.

Amelie Yavchitz

CONTACT

[email protected]

+33148036454

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Registry information

Official study title

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

Acronym: SIMCAT

Important dates

Study start: 2025
Primary completion: 2028
Study completion: 2029
First posted: Dec 17, 2024
Registry last updated: Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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