Status:
COMPLETED
Evaluating Medium-chain Triglycerides as a Temporary Intraocular Tamponading Agent for Retinal Detachment
Lead Sponsor:
University Hospital, Toulouse
Conditions:
Ophthalmopathy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Background : Surgery is needed in order to flatten and position a detached retina onto the choroid, to allow sealing of the tears and to prevent or reverse vision loss. In case of complex retinal deta...
Detailed Description
Previously a nonclinical study has provide an assessment of the safety and the local tissue effects of the Medium-Chain Triglyceride (MCT) tamponade agent manufactured by the company Arcadophta : Ther...
Eligibility Criteria
Inclusion
- Each patient with retinal detachment which requires a classical surgical procedure with silicone oil.
- Proliferative vitreoretinopathy over C2 regarding Retina Society classification
- Retinal detachment due to trauma to the eye
- Retinal detachment due to equatorial wound dehiscence which requires a classical surgical procedure with silicone oil.
- Retinal detachment due to complex proliferative diabetic retinopathy
- Recurrence of retinal detachment after ophthalmic gaz treatment
- Retinal detachment due to giant tear (\>90°C independently of the location into the eye.
Exclusion
- monophthalmic patient
- Eye with corneal dystrophy
- Intraocular pressure \> 25 mmHg under treatment
- Patient with travel difficulty or living place far away from the clinic
- Patient participating to another clinical study.
- Pregnant women or breastfeeding women
- Patient under tutors or curators
Key Trial Info
Start Date :
December 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 25 2023
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03855462
Start Date
December 17 2018
End Date
January 25 2023
Last Update
August 29 2023
Active Locations (2)
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1
Polyclinique Saint Roch
Montpellier, France
2
University Hospital Toulouse (Hospital Pierre Paul Riquet)
Toulouse, France, 31059