Evaluating Medium-chain Triglycerides as a Temporary Intraocular Tamponading Agent for Retinal De… (NCT03855462) | Clinical Trial Compass
CompletedNot Applicable
Evaluating Medium-chain Triglycerides as a Temporary Intraocular Tamponading Agent for Retinal Detachment
France10 participantsStarted 2018-12-17
Plain-language 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 detachment vitrectomies followed by ocular endotamponade - non-solid implants used in ophthalmology - is the most common treatment. Despite several options used by surgeons were not entirely satisfactory, no innovation were marketed in the ocular endotamponade field since decades.
Purpose : Regarding comparative physico-chemical properties of medium-chain triglycerides (MCT) with current tamponading agents (silicone oil or gases), it will be proposed to evaluate the MCT as an ocular endotamponade product.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Efficacy (tamponment efficacy supported by a flatten retina observation)