High MyopiaNCT03174639
High Myopia Macular Hole and Retinal Detachment Treated With Double ILM Flaps
A study testing Inverted and free ILM insertion in people with High Myopia and Macular Holes, run by National Taiwan University Hospital.
Trial summary
From July 2015 to December 2015, clinical record of 8 consecutive cases of macular hole with retinal detachment in high myopia treated with combined inverted and free ILM flap insertion into the hole were retrospectively reviewed. The anatomical and function outcomes were assessed. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- High Myopia, Macular Holes, Retinal Detachment
- What is being tested?
- Inverted and free ILM insertion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- 11 Mar 2016to 30 Jun 2016
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Macular hole with retinal detachment in high myopia
Who cannot join
- History of trauma, peripheral retinal breaks
About this study
Official title: High Myopia Macular Hole and Retinal Detachment Accepted Internal Limiting Membrane Flip Packing and Free Flap Was the Internal Limiting Membrane (ILM Flap Was Double)
From July 2015 to December 2015, clinical record of 8 consecutive cases of macular hole with retinal detachment in high myopia treated with combined inverted and free ILM flap insertion into the hole were retrospectively reviewed. The anatomical and function outcomes were assessed.
Read the detailed description
From July 2015 to December 2015, clinical record of 8 consecutive cases of macular hole with retinal detachment in high myopia treated with combined inverted and free ILM flap insertion into the hole were retrospectively reviewed. The anatomical and function outcomes were assessed. Patients with a history of trauma or concurrent peripheral breaks were excluded. The anatomical and function outcomes, including the status of the macular hole and retina were assessed.The study was approved by the ethnic committee and research board.
- Conditions
- High Myopia, Macular Holes, Retinal Detachment
- Being tested
- Inverted and free ILM insertion
- Medical subject headings
- Retinal Perforations, Retinal Detachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inverted and free ILM insertionProcedure or surgery
ILM was peeled and the ILM flap was inverted and inserted into the macular hole, followed by insertion of free ILM flap.
| Study group | Role | What they receive |
|---|---|---|
| Inverted and free ILM insertion | Experimental | Both inverted and free ILM flaps were inserted into the macular hole Receives: Procedure: Inverted and free ILM insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Closure of macular hole
Closure of macular hole demonstrated by optical coherence tomography
Measured: 3 months
Secondary outcomes (1)
Retinal reattachment
Retinal reattachment observed by fundoscopy
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2017
- Study start11 Mar 2016
- Primary completion30 Jun 2016
- Study completion30 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for High MyopiaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03174639
- Sponsor's protocol ID
- 201512113RINA
- Status last verified
- May 2017
- First submitted
- 23 May 2017
- Last updated
- 2 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen SN, Yang CM. Double Internal Limiting Membrane Insertion for Macular Hole-Associated Retinal Detachment. J Ophthalmol. 2017;2017:3236516. doi: 10.1155/2017/3236516. Epub 2017 Jul 30.
PubMed 28845304
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Myopia Macular Hole and Retinal Detachment Accepted Internal Limiting Membrane Flip Packing and Free Flap Was the Internal Limiting Membrane (ILM Flap Was Double)
- ClinicalTrials.gov ID
- NCT03174639
- Acronym / sponsor ID
- 201512113RINA
- Conditions
- High Myopia, Macular Holes, Retinal Detachment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 11 Mar 2016 (actual)
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 30 Jun 2016 (actual)
- First posted
- 2 Jun 2017 (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.
From July 2015 to December 2015, clinical record of 8 consecutive cases of macular hole with retinal detachment in high myopia treated with combined inverted and free ILM flap insertion into the hole were retrospectively reviewed. The anatomical and function outcomes were assessed.
Detailed description
From July 2015 to December 2015, clinical record of 8 consecutive cases of macular hole with retinal detachment in high myopia treated with combined inverted and free ILM flap insertion into the hole were retrospectively reviewed. The anatomical and function outcomes were assessed. Patients with a history of trauma or concurrent peripheral breaks were excluded. The anatomical and function outcomes, including the status of the macular hole and retina were assessed.The study was approved by the ethnic committee and research board.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inverted and free ILM insertion | Experimental | Procedure: Inverted and free ILM insertionBoth inverted and free ILM flaps were inserted into the macular hole |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Macular hole with retinal detachment in high myopia
Key exclusion criteria (1 listed)
- History of trauma, peripheral retinal breaks
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 |
|---|---|---|
| Inverted and free ILM insertionILM was peeled and the ILM flap was inverted and inserted into the macular hole, followed by insertion of free ILM flap. | Procedure or surgery | Inverted and free ILM insertion |
Primary outcome
Closure of macular hole
Time frame: 3 months
Closure of macular hole demonstrated by optical coherence tomography
1 secondary outcome
Retinal reattachment
Time frame: 3 months
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 2 Jun 2017.
- Derived from this study: PubMed 28845304Chen SN, Yang CM. Double Internal Limiting Membrane Insertion for Macular Hole-Associated Retinal Detachment. J Ophthalmol. 2017;2017:3236516. doi: 10.1155/2017/3236516. Epub 2017 Jul 30.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Inverted and free ILM insertion in people with High Myopia and Macular Holes, run by National Taiwan University Hospital.
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 2 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Closure of macular hole (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03174639, which also lists 1 linked publication.
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 2 Jun 2017; AzTrials last refreshed its copy on 31 Oct 2026.