An interventional study of MCT oil injection in Ophthalmopathy, sponsored by University Hospital, Toulouse. Completed at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-29.
Sponsored by University Hospital, Toulouse · Not applicable, Interventional, and Treatment
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.
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.
207 studies on the registry are indexed under Retinal Detachment; 27 are open to participants now.
This study's enrollment of 10 is below the median of 50 across 136 interventional studies indexed under Retinal Detachment.
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Exclusion Criteria:
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.
Efficacy (tamponment efficacy supported by a flatten retina observation)
Flatten retina observation by fundus exam
Time frame: 6 month
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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 6 month
Safety (Inflammation)
Presence of inflammation in the anterior chamber (Tyndall) or in the vitreous cavity according to the ophthalmic examination
Time frame: 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
Time frame: 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)
Time frame: 6 month
distance visual acuity measure to evaluate safety of MCT oil
Safety secondary outcomes is evaluated by distance visual acuity.
Time frame: 6 month
Plan to share: No
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University Hospital, Toulouse