OphthalmopathyMCTNCT03855462
Evaluating Medium-chain Triglycerides as a Temporary Intraocular Tamponading Agent for Retinal Detachment
A study testing MCT oil injection in people with Ophthalmopathy, run by University Hospital, Toulouse at 2 sites in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ophthalmopathy
- What is being tested?
- MCT oil injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesFrance
- Study dates
- 17 Dec 2018to 25 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
Polyclinique Saint Roch
Montpellier
University Hospital Toulouse (Hospital Pierre Paul Riquet)
Toulouse, 31059
About this study
Official title: Evaluating Efficacy and Safety of Medium-chain Triglycerides Used as a Temporary Intraocular Tamponading Agent for Retinal Detachment Treated by Endocular Surgery
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.
Read the detailed 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.
- Conditions
- Ophthalmopathy
- Being tested
- MCT oil injection
- Keywords
- endotamponade, retinal detachment, vitreoretinal proliferation
- Medical subject headings
- Eye Diseases, Retinal Detachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Device: MCT oil injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy (tamponment efficacy supported by a flatten retina observation)
Flatten retina observation by fundus exam
Measured: 6 month
Secondary outcomes (9)
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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 6 month
Safety (Inflammation)
Presence of inflammation in the anterior chamber (Tyndall) or in the vitreous cavity according to the ophthalmic examination
Measured: 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
Measured: 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)
Measured: 6 month
distance visual acuity measure to evaluate safety of MCT oil
Safety secondary outcomes is evaluated by distance visual acuity.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2019
- Study start17 Dec 2018
- Primary completion25 Jan 2023
- Study completion25 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OphthalmopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Veronique Pagot-Mathis, MD, Principal investigator, CHU of Toulouse, FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03855462
- Sponsor's protocol ID
- RC31/17/0360
- Acronym
- MCT
- Status last verified
- Aug 2023
- First submitted
- 5 Dec 2018
- Last updated
- 29 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Efficacy and Safety of Medium-chain Triglycerides Used as a Temporary Intraocular Tamponading Agent for Retinal Detachment Treated by Endocular Surgery
- ClinicalTrials.gov ID
- NCT03855462
- Acronym / sponsor ID
- MCT / RC31/17/0360
- Conditions
- Ophthalmopathy
- Keywords
- endotamponade, retinal detachment, vitreoretinal proliferation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 17 Dec 2018 (actual)
- Primary completion
- 25 Jan 2023 (actual)
- Study completion
- 25 Jan 2023 (actual)
- First posted
- 26 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MCT oil injection | Experimental | Device: MCT oil injectionThe 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MCT oil injectionThe 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. | Device | MCT oil injection |
Primary outcome
Efficacy (tamponment efficacy supported by a flatten retina observation)
Time frame: 6 month
Flatten retina observation by fundus exam
9 secondary outcomes
Efficacy (injection facility of MCT oïl)
Time frame: Inclusion day : Day 0
Efficacy (ablation facility of MCT oïl)
Time frame: 6 weeks
Safety (MCT emulsification)
Time frame: 6 month
presence of micro-bubbles after post MCT ablation assessed according to a 5-point scale
Time frame: 6 month
Presence of hypertonia (intraocular pressure)
Time frame: 6 month
Safety (Inflammation)
Time frame: 6 month
Cataract presence (lens opacity classification system III)
Time frame: 6 month
Keratopathy presence to evaluate safety of MCT oil
Time frame: 6 month
distance visual acuity measure to evaluate safety of MCT oil
Time frame: 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Veronique Pagot-Mathis, MD principal investigator
CHU of Toulouse, FRANCE
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MCT oil injection in people with Ophthalmopathy, run by University Hospital, Toulouse at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy (tamponment efficacy supported by a flatten retina observation) (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2023.