MedTrace Logo

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

NCT03855462 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-08-29

No results posted yet for this study

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.

Conditions

  • Ophthalmopathy

Interventions

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.

Sponsors & Collaborators

  • University Hospital, Toulouse

    lead OTHER

Principal Investigators

  • Veronique Pagot-Mathis, MD · CHU of Toulouse, FRANCE

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-17
Primary Completion
2023-01-25
Completion
2023-01-25

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03855462 on ClinicalTrials.gov