Cataract BilateralSIMCATNCT06737562
Medico-economic Evaluation of Immediately Sequential Bilateral Cataract Surgery Compared With Delayed Sequential Cataract Surgery in France
A study testing Immediatly sequential bilateral cataract surgery and Delayed sequential bilateral cataract surgery in people with Cataract Bilateral and Bilateral Cataracts, run by Fondation Ophtalmologique Adolphe de Rothschild at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract Bilateral, Bilateral Cataracts, Bilateral Cataract
- What is being tested?
- Immediatly sequential bilateral cataract surgery and Delayed sequential bilateral cataract surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 4 sitesFrance
- Study dates
- 3 Jul 2025to Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Recruiting
Chu Morvan
Brest
Béatrice COCHENER, Pr, +33298223440, beatrice.cochener@univ-brest.fr
- Recruiting
Clinical Judge
Marseille
Pascal ROZOT, Dr, +33491222429, pascal.rozot@dr-rozot.com
- Not yet recruiting
Cochin Hospital
Paris
Dominique MONNET, Pr, +33158412201, dominique.monnet@aphp.fr
- Recruiting
Fondation Ophtalmologique Adolphe de Rothschild
Paris
Alain SAAD, Dr, +33 6 62 92 30 02, asaad@for.paris
About this study
Official title: Medico-economic Evaluation of Immediately Sequential Bilateral Cataract Surgery Compared With Delayed Sequential Cataract Surgery in France: a Multicenter Randomized Controlled Trial
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
- Being tested
- Immediatly sequential bilateral cataract surgery, Delayed sequential bilateral cataract surgery
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediatly sequential bilateral cataract surgeryProcedure or surgery
Immediatly sequential bilateral cataract surgery
Delayed sequential bilateral cataract surgeryProcedure or surgery
Delayed sequential bilateral cataract surgery : 3 weeks +/-1 week between the two procedures
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Delayed sequential bilateral cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months after index surgery (bilateral or on the first eye)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start3 Jul 2025
- Primary completionJul 2028 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cataract BilateralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 242 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06737562
- Sponsor's protocol ID
- ASD_2023_5
- Acronym
- SIMCAT
- Status last verified
- Dec 2025
- First submitted
- 12 Dec 2024
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medico-economic Evaluation of Immediately Sequential Bilateral Cataract Surgery Compared With Delayed Sequential Cataract Surgery in France: a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06737562
- Acronym / sponsor ID
- SIMCAT / ASD_2023_5
- Conditions
- Cataract Bilateral, Bilateral Cataracts, Bilateral Cataract
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 242 participants (estimated)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 3 Jul 2025 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 17 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ISBCS | Experimental | Procedure: Immediatly sequential bilateral cataract surgeryBoth 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. |
| DSBCS | Active comparator | Procedure: Delayed sequential bilateral cataract surgeryOnly 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immediatly sequential bilateral cataract surgeryImmediatly sequential bilateral cataract surgery | Procedure or surgery | ISBCS |
| Delayed sequential bilateral cataract surgeryDelayed sequential bilateral cataract surgery : 3 weeks +/-1 week between the two procedures | Procedure or surgery | DSBCS |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediatly sequential bilateral cataract surgery and Delayed sequential bilateral cataract surgery in people with Cataract Bilateral and Bilateral Cataracts, run by Fondation Ophtalmologique Adolphe de Rothschild at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amelie Yavchitz (+33148036454, ayavchitz@for.paris), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cost-utility of ISBCS compared to DSBCS (time frame: 3 months after index surgery (bilateral or on the first eye)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.