Evaluating Medium-chain Triglycerides as a Temporary Intraocular

Status Completed

Clinical Trial 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.

Clinical Trial 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 : There were no histopathologic findings or irritation events that were directly attributable to the MCT device. In conclusion, under the conditions of the study, the MCT device did not induce any adverse local tissue effects compared to a control tamponading agent silicone oil. The present clinical study is the first use of MCT tamponade agent which assigns human participants. The MCT tamponade agent studied is manufactured by the company Arcadophta and designed as a Class IIb medical device in Europe. Tamponment efficacy and human eye safety of the device are supported by a flatten retina observation and a healthy eye fundus exam respectively as long as the tamponade agent is present. The patient treatment is the classical surgical procedure which is used for retinal detachment with silicone oil. - Vitrectomy, then flattened retina, and finally MCT injection in place of the vitreous. - MCT ablation after 4 to 6 weeks (after effective retinopexy) The patient follow-up begins 4 days before treatment , then 3 time-points exams are performed before MCT ablation and 4 time-points exams are performed after MCT ablation for a total patient follow-up duration of 6 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03855462
Study type	Interventional
Source	University Hospital, Toulouse
Contact
Status	Completed
Phase	N/A
Start date	December 17, 2018
Completion date	January 25, 2023

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Evaluating Medium-chain Triglycerides as a Temporary Intraocular Tamponading Agent for Retinal Detachment — MCT

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms