NCT03855462

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

Evaluating Efficacy and Safety of Medium-chain Triglycerides Used as a Temporary Intraocular Tamponading Agent for Retinal Detachment Treated by Endocular Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University Hospital, Toulouse · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 : 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.

Conditions

• Ophthalmopathy

Interventions

Type	Name	Description
DEVICE	MCT oil injection	The patient treatment is the classical surgical procedure which is used for retinal detachment with MCT oil : * Vitrectomy, then flattened retina, and finally MCT injection in place of the vitreous. * MCT ablation after 4 to 6 weeks (after effective retinopexy) * after MCT ablation, total follow-up duration by patient is 6 months.

Timeline

• Start date: 2018-12-17
• Primary completion: 2023-01-25
• Completion: 2023-01-25
• First posted: 2019-02-26
• Last updated: 2023-08-29

Locations

2 sites across 1 country: France