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

Toulouse University Hospital

Status: Completed

Conditions: Ophthalmopathy

Treatments: Device: MCT oil injection

Study type: Interventional

Funder types: Other

Identifiers

NCT03855462

RC31/17/0360

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

MCT oil injection

Experimental group

Description:

The patient treatment is the classical surgical procedure which is used for retinal detachment with silicon oil medium-chain triglycerides (MCT) as tamponade agent : * Vitrectomy, then flattened retina, and finally MCT injection in place of the vitreous. * MCT ablation after 4 to 6 weeks (after effective retinopexy)

Treatment:

Device: MCT oil injection