Retinal DetachmentILMFCMHRDPDRNCT03618498
Internal Limiting Membrane Flaps for Coexistent Macular Hole and Retinal Detachment
A study testing ILM flaps insertion techniques or free ILM flaps. in people with Retinal Detachment, run by Changhua Christian Hospital at 1 site in Taiwan.
Trial summary
Purpose: To evaluate the logical surgical approaches in closing macular holes in eyes of proliferative diabetic retinopathy with retinal detachment Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Retinal Detachment
- What is being tested?
- ILM flaps insertion techniques or free ILM flaps.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteTaiwan
- Study dates
- 7 Mar 2018to 15 Jul 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients were proliferative diabetic retinopathy suffering from MH with RD.
Who cannot join
- Patients were not proliferative diabetic retinopathy suffering from MH with RD.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Internal Limiting Membrane Flaps for Coexistent Macular Hole and Retinal Detachment in Eyes of Proliferative Diabetic Retinopathy
Purpose: To evaluate the logical surgical approaches in closing macular holes in eyes of proliferative diabetic retinopathy with retinal detachment
Read the detailed description
High MH closure rate can be achieved. Other than high myopia, MH with RD may appear in several conditions, such as severe vitreomacular traction, proliferative diabetic retinopathy (PDR).clinical charts were reviewed of patients of proliferative diabetic retinopathy suffering from MH with RD who were treated with vitrectomy combined with inverted epiretinal ILM flap,inverted ILM flaps insertion techniques, or free ILM flaps.Standard 3-port 23 or 25 gauged pars plana vitrectomy was performed. After core vitrectomy, anterior-posterior oriented tractions as well as all fibrovascular tissues were removed as thoroughly as possible.The patients were kept in a facedown position overnight and were allowed to take any positions except supine for approximately one week.Various surgical approaches utilizing in managing macular hole may effectively closing macular holes and reattach retina.
- Conditions
- Retinal Detachment
- Being tested
- ILM flaps insertion techniques or free ILM flaps.
- Keywords
- macular hole, retinal detachment, PDR
- Medical subject headings
- Retinal Detachment, Retinal Perforations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ILM flaps insertion techniques or free ILM flaps.Procedure or surgery
The ILM flap anchoring on the hole edge was inverted and covered the hole.Otherwise, temporal side ILM flap was used. However, if the risk of ILM flipping back was judged to be high, ILM insertion instead of ILM hole coverage was adopted.If the size of the ILM flaps was judged inadequate, the double ILM insertion technique was used, done by adding a piece of previously obtained free ILM flap on top of the inverted ILM tissue until they were securely in place.
| Study group | Role | What they receive |
|---|---|---|
| Patient accept surgery | Other | Proliferative diabetic retinopathy suffering from MH with RD who were treated with vitrectomy combined with inverted epiretinal ILM flap,inverted ILM flaps insertion techniques, or free ILM flaps. Receives: Procedure: ILM flaps insertion techniques or free ILM flaps. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wilcoxon Sign-Rank test
A statistical comparison of average of two dependent samples
Measured: Baseline, 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2018
- Study start7 Mar 2018
- Primary completion31 May 2018
- Study completion15 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal DetachmentStudies 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
- Intervention model
- Sequential
- Model description
- A 25-gauged blunt-tipped needle connected with Viscoat® (Alcon laboratories, Fort Worth, TX, USA) containing syringe was placed within the macular hole just below the level of the macular hole. A small amount of Viscoat® was injected into and around the hole. An ICG solution (25 mg ICG in 15 ml 5% glucose-water solution, final concentration = 1.7 mg/ml) was then carefully applied around the macular hole within the arcade.Excessive ICG was immediately removed by suction. ILM at the parafoveal area was peeled in a circular fashion. Care was taken not to peel the ILM flap across the hole edge. If possible, at least 1.5 to 2 disc area of partially detached ILM around the hole was left in place with central part remained attached to the edge of the hole.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhua Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, San Ni Chen, Changhua Christian Hospital
- Investigators
- Chen San-Ni, MD, Study director, Changhua Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03618498
- Sponsor's protocol ID
- 180314
- Acronym
- ILMFCMHRDPDR
- Status last verified
- Aug 2018
- First submitted
- 23 Jul 2018
- Last updated
- 8 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internal Limiting Membrane Flaps for Coexistent Macular Hole and Retinal Detachment in Eyes of Proliferative Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT03618498
- Acronym / sponsor ID
- ILMFCMHRDPDR / 180314
- Conditions
- Retinal Detachment
- Keywords
- macular hole, retinal detachment, PDR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Changhua Christian HospitalUniversity, hospital or other
- Study start
- 7 Mar 2018 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 15 Jul 2018 (actual)
- First posted
- 7 Aug 2018 (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.
Purpose: To evaluate the logical surgical approaches in closing macular holes in eyes of proliferative diabetic retinopathy with retinal detachment
Detailed description
High MH closure rate can be achieved. Other than high myopia, MH with RD may appear in several conditions, such as severe vitreomacular traction, proliferative diabetic retinopathy (PDR).clinical charts were reviewed of patients of proliferative diabetic retinopathy suffering from MH with RD who were treated with vitrectomy combined with inverted epiretinal ILM flap,inverted ILM flaps insertion techniques, or free ILM flaps.Standard 3-port 23 or 25 gauged pars plana vitrectomy was performed. After core vitrectomy, anterior-posterior oriented tractions as well as all fibrovascular tissues were removed as thoroughly as possible.The patients were kept in a facedown position overnight and were allowed to take any positions except supine for approximately one week.Various surgical approaches utilizing in managing macular hole may effectively closing macular holes and reattach retina.
Study design
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A 25-gauged blunt-tipped needle connected with Viscoat® (Alcon laboratories, Fort Worth, TX, USA) containing syringe was placed within the macular hole just below the level of the macular hole. A small amount of Viscoat® was injected into and around the hole. An ICG solution (25 mg ICG in 15 ml 5% glucose-water solution, final concentration = 1.7 mg/ml) was then carefully applied around the macular hole within the arcade.Excessive ICG was immediately removed by suction. ILM at the parafoveal area was peeled in a circular fashion. Care was taken not to peel the ILM flap across the hole edge. If possible, at least 1.5 to 2 disc area of partially detached ILM around the hole was left in place with central part remained attached to the edge of the hole.
| Arm | Type | Receives |
|---|---|---|
| Patient accept surgery | Other | Procedure: ILM flaps insertion techniques or free ILM flaps.Proliferative diabetic retinopathy suffering from MH with RD who were treated with vitrectomy combined with inverted epiretinal ILM flap,inverted ILM flaps insertion techniques, or free ILM flaps. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients were proliferative diabetic retinopathy suffering from MH with RD.
Key exclusion criteria (1 listed)
- Patients were not proliferative diabetic retinopathy suffering from MH with RD.
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 |
|---|---|---|
| ILM flaps insertion techniques or free ILM flaps.The ILM flap anchoring on the hole edge was inverted and covered the hole.Otherwise, temporal side ILM flap was used. However, if the risk of ILM flipping back was judged to be high, ILM insertion instead of ILM hole coverage was adopted.If the size of the ILM flaps was judged inadequate, the double ILM insertion technique was used, done by adding a piece of previously obtained free ILM flap on top of the inverted ILM tissue until they were securely in place. | Procedure or surgery | Patient accept surgery |
Primary outcome
Wilcoxon Sign-Rank test
Time frame: Baseline, 12 months.
A statistical comparison of average of two dependent samples
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 8 Aug 2018.
- Individual participant dataSharing planned: Yes
Related trials for Retinal Detachment
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Prevention of ProliFerative Vitreoretinopathy With Intravitreal MethotreXate in Primary Retinal DEtachment Repair (FIXER) Trial
Proliferative Vitreoretinopathy, Rhegmatogenous Retinal Detachment
RecruitingObservational study
Surgical Procedure Efficiency Evaluation stuDy
Cataract, Vitreous Hemorrhage
RecruitingPhase 3
Treatment of Retinal Detachment in People Who Have Not Had Cataract Surgery With Vitrectomy vs Vitrectomy and Cataract Removal
Rhegmatogenous Retinal Detachment
Recruiting
Retinal Detachment Prevention (Laser Prophylaxis) in Stickler Syndrome (SS)
Stickler Syndrome Type 1, Stickler Syndrome Type 2
RecruitingObservational study
Intraoperative OCT Guidance of Intraocular Surgery II
Macular Holes, Epiretinal Membrane
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.
Chen San-Ni, MD study director
Changhua Christian Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ILM flaps insertion techniques or free ILM flaps. in people with Retinal Detachment, run by Changhua Christian Hospital at 1 site in Taiwan.
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 1 inclusion and 1 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 8 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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?
Wilcoxon Sign-Rank test (time frame: Baseline, 12 months.). 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 8 Aug 2018.