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Completed

NCT Number: NCT03855462

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

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.

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Key information

Conditions

Ophthalmopathy Eye Diseases Retinal Detachment Retinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Polyclinique Saint Roch, Montpellier, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MCT oil injection

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.

Primary outcomes

  1. Efficacy (tamponment efficacy supported by a flatten retina observation)

    Time frame: 6 month

    Flatten retina observation by fundus exam

Secondary outcomes

  1. Efficacy (injection facility of MCT oïl)

    Time frame: Inclusion day : Day 0

    Facility injection of MCT oil as tamponment assessed according to a 4-point scale (from 0=very easy to 3=very difficult)

  2. Efficacy (ablation facility of MCT oïl)

    Time frame: 6 weeks

    Facility ablation of MCT oil assessed according to a 4-point scale (from 0=very easy to 3=very difficult)

  3. Safety (MCT emulsification)

    Time frame: 6 month

    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

  4. presence of micro-bubbles after post MCT ablation assessed according to a 5-point scale

    Time frame: 6 month

    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

  5. Presence of hypertonia (intraocular pressure)

    Time frame: 6 month

    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. Safety (Inflammation)

    Time frame: 6 month

    Presence of inflammation in the anterior chamber (Tyndall) or in the vitreous cavity according to the ophthalmic examination

  7. Cataract presence (lens opacity classification system III)

    Time frame: 6 month

    The presence or worsening of cataract will be assessed according to the lens opacity classification system III

  8. Keratopathy presence to evaluate safety of MCT oil

    Time frame: 6 month

    Presence of keratopathy will be assessed using a 4-point scale (from 0 = absence to 3 = keratopathy with strips)

  9. distance visual acuity measure to evaluate safety of MCT oil

    Time frame: 6 month

    Safety secondary outcomes is evaluated by distance visual acuity.

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: MCT

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Feb 26, 2019
Registry last updated
Aug 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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