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

Ophthalmopathy Clinical Trial

— MCT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03855462
• Other study ID #: RC31/17/0360
• Status: Completed
• Phase: N/A
• Start date: December 17, 2018
• Est. completion date: January 25, 2023

Study information

• Verified date: August 2023
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 25, 2023
• Est. primary completion date: January 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Eye Diseases
• Ophthalmopathy
• Retinal Detachment

Intervention

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.

Locations

Country	Name	City	State
France	Polyclinique Saint Roch	Montpellier
France	University Hospital Toulouse (Hospital Pierre Paul Riquet)	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy (tamponment efficacy supported by a flatten retina observation)	Flatten retina observation by fundus exam	6 month
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Safety (Inflammation)	Presence of inflammation in the anterior chamber (Tyndall) or in the vitreous cavity according to the ophthalmic examination	6 month
Secondary	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
Secondary	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
Secondary	distance visual acuity measure to evaluate safety of MCT oil	Safety secondary outcomes is evaluated by distance visual acuity.	6 month