Idiopathic Macular HoleNCT04683276
ILM Inverted Flap Size in Macular Hole
A study testing pars plana vitrectomy with ILM inverted flap in people with Idiopathic Macular Hole, run by Mansoura University at 1 site in Egypt.
Trial summary
In the current study, the investigators described the results of a randomized, comparative clinical trial that was conducted to study the impact of the size of internal limiting membrane (ILM) inverted flap on rate and timing of idiopathic macular hole closure. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Idiopathic Macular Hole
- What is being tested?
- pars plana vitrectomy with ILM inverted flap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2019to 1 Oct 2020
- 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
- Eyes with stage 4 idiopathic MHs with a diameter >250µm on spectral domain optical coherence tomography (SD-OCT)
Who cannot join
- traumatic MH
- myopic MHs,
- MH secondary to retinal detachment,
- long-standing MH> 12 months
- previous retinal surgeries
- high myopia with an axial length > 26.0 mm
- other ocular pathologies interfering with the interpretation of the OCT reports.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of the Inverted Internal Limiting Membrane Flap Diameter on Idiopathic Macular Hole Closure: Comparative Randomized Study
In the current study, the investigators described the results of a randomized, comparative clinical trial that was conducted to study the impact of the size of internal limiting membrane (ILM) inverted flap on rate and timing of idiopathic macular hole closure.
Read the detailed description
A prospective randomized comparative study included patients with idiopathic macular hole (MH) attending outpatient clinic.Eligible eyes were divided into 2 groups based on the narrowest diameter of the MH measured by spectral domain optical coherence tomography (SD-OCT). MHs from 250 to 400µm were classified as Medium-sized MHs and MHs > 400 µm were classified as Large-sized MHs. Within each group, eyes were randomly assigned to either small-flap (1-2DD) or large flap (from >2 to 4DD).
- Conditions
- Idiopathic Macular Hole
- Being tested
- pars plana vitrectomy with ILM inverted flap
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pars plana vitrectomy with ILM inverted flapProcedure or surgery
Complete vitrectomy was done with the aid of triamcinolone acetonide followed by fluid-air exchange. Staining of the ILM was carried with 0.05% solution of Brilliant Blue dye (BBG), (Ocublue plus, Aurolab, India) for 30 seconds, ILM peeling was proceeded leaving a circle of ILM measuring approximately 1-2 DD in SF groups and >2 to 4DD in LF group, centered around the MH. The ILM outside the parafoveal area was peeled to the arcade. The ILM around the hole was then detached from the retina up to the edge of the hole. The ILM flap around the edge of the hole was inverted over the MH using a scraper.
| Study group | Role | What they receive |
|---|---|---|
| small flap medium-sized macular hole (SFMM) | Active comparator | small flap (1-2 disc-diameter) was performed in medium sized macular hole (250-400 um) Receives: Procedure: pars plana vitrectomy with ILM inverted flap |
| large flap medium-sized macular hole (LFMM) | Active comparator | large flap (3-4 disc-diameter) was performed in medium sized macular hole (250-400 um) Receives: Procedure: pars plana vitrectomy with ILM inverted flap |
| small flap large-sized macular hole (SFLM) | Active comparator | small flap (1-2 disc-diameter) was performed in Large sized macular hole (>400 um) Receives: Procedure: pars plana vitrectomy with ILM inverted flap |
| large flap Large-sized macular hole (LFLM) | Active comparator | large flap (3-4 disc-diameter) was performed in large sized macular hole (>400 um) Receives: Procedure: pars plana vitrectomy with ILM inverted flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of macular hole closure
defined as the proportion of the eyes with complete MH closure based on SD-OCT findings
Measured: 6 months
Secondary outcomes (2)
timing of MH closure
the time of complete macular hole closure
Measured: 6 months
BCVA
best corrected visual acuity
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start1 Feb 2019
- Primary completion1 Apr 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Macular HoleStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04683276
- Sponsor's protocol ID
- ILM flap size
- Status last verified
- Dec 2020
- First submitted
- 19 Dec 2020
- Last updated
- 29 Dec 2020
- 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 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Inverted Internal Limiting Membrane Flap Diameter on Idiopathic Macular Hole Closure: Comparative Randomized Study
- ClinicalTrials.gov ID
- NCT04683276
- Acronym / sponsor ID
- ILM flap size
- Conditions
- Idiopathic Macular Hole
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 24 Dec 2020 (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.
In the current study, the investigators described the results of a randomized, comparative clinical trial that was conducted to study the impact of the size of internal limiting membrane (ILM) inverted flap on rate and timing of idiopathic macular hole closure.
Detailed description
A prospective randomized comparative study included patients with idiopathic macular hole (MH) attending outpatient clinic.Eligible eyes were divided into 2 groups based on the narrowest diameter of the MH measured by spectral domain optical coherence tomography (SD-OCT). MHs from 250 to 400µm were classified as Medium-sized MHs and MHs > 400 µm were classified as Large-sized MHs. Within each group, eyes were randomly assigned to either small-flap (1-2DD) or large flap (from >2 to 4DD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| small flap medium-sized macular hole (SFMM) | Active comparator | Procedure: pars plana vitrectomy with ILM inverted flapsmall flap (1-2 disc-diameter) was performed in medium sized macular hole (250-400 um) |
| large flap medium-sized macular hole (LFMM) | Active comparator | Procedure: pars plana vitrectomy with ILM inverted flaplarge flap (3-4 disc-diameter) was performed in medium sized macular hole (250-400 um) |
| small flap large-sized macular hole (SFLM) | Active comparator | Procedure: pars plana vitrectomy with ILM inverted flapsmall flap (1-2 disc-diameter) was performed in Large sized macular hole (>400 um) |
| large flap Large-sized macular hole (LFLM) | Active comparator | Procedure: pars plana vitrectomy with ILM inverted flaplarge flap (3-4 disc-diameter) was performed in large sized macular hole (>400 um) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Eyes with stage 4 idiopathic MHs with a diameter >250µm on spectral domain optical coherence tomography (SD-OCT)
Key exclusion criteria (7 listed)
- traumatic MH
- myopic MHs,
- MH secondary to retinal detachment,
- long-standing MH> 12 months
- previous retinal surgeries
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 |
|---|---|---|
| pars plana vitrectomy with ILM inverted flapComplete vitrectomy was done with the aid of triamcinolone acetonide followed by fluid-air exchange. Staining of the ILM was carried with 0.05% solution of Brilliant Blue dye (BBG), (Ocublue plus, Aurolab, India) for 30 seconds, ILM peeling was proceeded leaving a circle of ILM measuring approximately 1-2 DD in SF groups and >2 to 4DD in LF group, centered around the MH. The ILM outside the parafoveal area was peeled to the arcade. The ILM around the hole was then detached from the retina up to the edge of the hole. The ILM flap around the edge of the hole was inverted over the MH using a scraper. | Procedure or surgery | large flap Large-sized macular hole (LFLM), large flap medium-sized macular hole (LFMM), small flap large-sized macular hole (SFLM), small flap medium-sized macular hole (SFMM) |
Primary outcome
rate of macular hole closure
Time frame: 6 months
defined as the proportion of the eyes with complete MH closure based on SD-OCT findings
2 secondary outcomes
timing of MH closure
Time frame: 6 months
BCVA
Time frame: 6 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 29 Dec 2020.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pars plana vitrectomy with ILM inverted flap in people with Idiopathic Macular Hole, run by Mansoura University at 1 site in Egypt.
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 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 Dec 2020. 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 Egypt. 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?
rate of macular hole closure (time frame: 6 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 29 Dec 2020.