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

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

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.

Study Overview

• Status: Completed
• Conditions: Ophthalmopathy
• Intervention / Treatment: Device: MCT oil injection

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Veronique Pagot-Mathis, MD; Phone Number: 33 05 61 77 68 81; Email: pagot-mathis.v@chu-toulouse.fr
• Study Contact Backup: Name: Vincent Soler, MD; Phone Number: 33 05 61 77 68 81; Email: soler.v@chu-toulouse.fe

Study Locations

• France
  • Montpellier, France
    • Polyclinique Saint Roch
  • Toulouse, France, 31059
    • University Hospital Toulouse (Hospital Pierre Paul Riquet)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy (tamponment efficacy supported by a flatten retina observation)	Flatten retina observation by fundus exam	6 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy (injection facility of MCT oïl)	Facility injection of MCT oil as tamponment assessed according to a 4-point scale (from 0=very easy to 3=very difficult)	Inclusion day : Day 0
Efficacy (ablation facility of MCT oïl)	Facility ablation of MCT oil assessed according to a 4-point scale (from 0=very easy to 3=very difficult)	6 weeks
Safety (MCT emulsification)	MCT emulsification assessed according to 5-point scale (from grade 0 = absence of emulsification to grade 4= emulsification that not allow to distinguish retinal details, unobservable fundus	6 month
presence of micro-bubbles after post MCT ablation assessed according to a 5-point scale	Safety secondary outcomes is evaluate by presence of micro-bubbles post MCT ablation according to 5-point scale (from grade 0 = absence of emulsification to grade 4= emulsification that not allow to distinguish retinal details, unobservable fundus	6 month
Presence of hypertonia (intraocular pressure)	The presence of hypertonia will be assessed by measurement of the intraocular pressure. An ocular hypertonia is defined by an intraocular pressure superior to 25 mmHg	6 month
Safety (Inflammation)	Presence of inflammation in the anterior chamber (Tyndall) or in the vitreous cavity according to the ophthalmic examination	6 month
Cataract presence (lens opacity classification system III)	The presence or worsening of cataract will be assessed according to the lens opacity classification system III	6 month
Keratopathy presence to evaluate safety of MCT oil	Presence of keratopathy will be assessed using a 4-point scale (from 0 = absence to 3 = keratopathy with strips)	6 month
distance visual acuity measure to evaluate safety of MCT oil	Safety secondary outcomes is evaluated by distance visual acuity.	6 month

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Veronique Pagot-Mathis, MD, CHU of Toulouse, FRANCE

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2018
• Primary Completion (Actual): January 25, 2023
• Study Completion (Actual): January 25, 2023

Study Registration Dates

• First Submitted: December 5, 2018
• First Submitted That Met QC Criteria: February 25, 2019
• First Posted (Actual): February 26, 2019

Study Record Updates

• Last Update Posted (Actual): August 29, 2023
• Last Update Submitted That Met QC Criteria: August 28, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: retinal detachment; endotamponade; vitreoretinal proliferation
• Additional Relevant MeSH Terms: Retinal Diseases; Eye Diseases; Retinal Detachment
• Other Study ID Numbers: RC31/17/0360

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No