NCT03855462

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2018

Completed
12 days until next milestone

Study Start

First participant enrolled

December 17, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 26, 2019

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2023

Completed
Last Updated

August 29, 2023

Status Verified

August 1, 2023

Enrollment Period

4.1 years

First QC Date

December 5, 2018

Last Update Submit

August 28, 2023

Conditions

Ophthalmopathy

Keywords

endotamponaderetinal detachmentvitreoretinal proliferation

Outcome Measures

Primary Outcomes (1)

  • Efficacy (tamponment efficacy supported by a flatten retina observation)

    Flatten retina observation by fundus exam

    6 month

Secondary Outcomes (9)

  • Efficacy (injection facility of MCT oïl)

    Inclusion day : Day 0

  • Efficacy (ablation facility of MCT oïl)

    6 weeks

  • Safety (MCT emulsification)

    6 month

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

    6 month

  • Presence of hypertonia (intraocular pressure)

    6 month

  • +4 more secondary outcomes

Study Arms (1)

MCT oil injection

EXPERIMENTAL

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

Interventions

MCT oil injectionDEVICE

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.

MCT oil injection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Polyclinique Saint Roch

Montpellier, France

Location

University Hospital Toulouse (Hospital Pierre Paul Riquet)

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Eye DiseasesRetinal Detachment

Interventions

Mucociliary Clearance

Condition Hierarchy (Ancestors)

Retinal Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosisRespiratory Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Veronique Pagot-Mathis, MD

    CHU of Toulouse, FRANCE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2018

First Posted

February 26, 2019

Study Start

December 17, 2018

Primary Completion

January 25, 2023

Study Completion

January 25, 2023

Last Updated

August 29, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)