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

NCT ID: NCT03855462

Last Updated: 2023-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-17
• Study Completion Date: 2023-01-25

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 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MCT oil injection

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)

Group Type: EXPERIMENTAL

MCT oil injection

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Veronique Pagot-Mathis, MD

Role: PRINCIPAL_INVESTIGATOR

CHU of Toulouse, FRANCE

Locations

Polyclinique Saint Roch

Montpellier, , France

University Hospital Toulouse (Hospital Pierre Paul Riquet)

Toulouse, , France

Countries

France

Other Identifiers

RC31/17/0360

Identifier Type: -

Identifier Source: org_study_id