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Compares treatment options for Cataract Bilateral
Official title Medico-economic Evaluation of Immediately Sequential Bilateral Cataract Surgery Compared With Delayed Sequential Cataract Surgery in France
ClinicalTrials.gov ID: NCT06737562
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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
You likely can't join if
- 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 (\ 27 mm) High...
- Presence of risk factors for intraoperative complications Ocular, adnexal or anatomical abnormalities History of retinal detachment Lens dislocation...
- Presence of risk factors for corneal edema (e.g. Fuchs' endothelial dystrophy)
See the full eligibility 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
- 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 (\ 27 mm) High myopia with posterior staphyloma History of corneal surgery (LASIK, surface...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Brest, France
- Marseille, France
- Paris, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brest, France; Marseille, France; Paris, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.