Clinical trial NCT03855462: Evaluating Medium-chain Triglycerides as a Temporary Intraocular Tamponading Agent for Retinal Detachment
Official title: Evaluating Efficacy and Safety of Medium-chain Triglycerides Used as a Temporary Intraocular Tamponading Agent for Retinal Detachment Treated by Endocular Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ophthalmopathy
Keywords: endotamponade
retinal detachment
vitreoretinal proliferation
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2019-02-26
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Efficacy (tamponment efficacy supported by a flatten retina observation)
timeFrame: 6 month
Secondary outcomes:
measure: Efficacy (injection facility of MCT oïl)
timeFrame: Inclusion day : Day 0
measure: Efficacy (ablation facility of MCT oïl)
timeFrame: 6 weeks
measure: Safety (MCT emulsification)
timeFrame: 6 month
measure: presence of micro-bubbles after post MCT ablation assessed according to a 5-point scale
timeFrame: 6 month
measure: Presence of hypertonia (intraocular pressure)
timeFrame: 6 month
measure: Safety (Inflammation)
timeFrame: 6 month
measure: Cataract presence (lens opacity classification system III)
timeFrame: 6 month
measure: Keratopathy presence to evaluate safety of MCT oil
timeFrame: 6 month
measure: distance visual acuity measure to evaluate safety of MCT oil
timeFrame: 6 month
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Polyclinique Saint Roch
city: Toulouse
country: France
facility: University Hospital Toulouse (Hospital Pierre Paul Riquet)
Study officials:
affiliation: CHU of Toulouse, FRANCE
name: Veronique Pagot-Mathis, MD
role: PRINCIPAL_INVESTIGATOR
References: