Macular HolesNCT05269563
Double Flap Technique for Macular Hole
A study testing Surgical intervention in people with Macular Holes, run by Omer Othman Abdullah at 1 site in Iraq.
Trial summary
Double flapping technique to close the macular hole. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Macular Holes
- What is being tested?
- Surgical intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIraq
- Study dates
- 1 Jan 2022to 23 Mar 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Full thickness macular hole
Who cannot join
- Partial-thickness macular hole
- Vitreomacular traction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double Flap Technique Utilizing ERM and ILM for Macular Hole
Double flapping technique to close the macular hole.
Read the detailed description
Recently, it is agreed to close the macular hole with the retinal innermost layer; which is called internal limiting membrane (ILM), in most cases, the hole closes. But, sometimes the ILM single flap might displace resulting in a persistent hole.
Therefore, the investigators tried to make two flaps utilizing ILM, and sometimes certain patients have a very thin membrane over the retina; it is called epiretinal membrane (ERM). The investigators use the double flapping technique by utilizing ERM; therefore, the ILM remains and can be used if the hole resists closing with the first surgical interventions.
Here, the investigators did not use any new materials with unknown side effects on the human retina. Although the flap technique is well known; however, investigators are making a double flap to decrease the chance of persisting macular holes.
The visual recovery will be appeared in the post-operative period, whether it is the same, better, or worse.
- Conditions
- Macular Holes
- Being tested
- Surgical intervention
- Keywords
- Double Flaps
- Medical subject headings
- Retinal Perforations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical interventionOther
Pars Plana Vitrectomy for Macular Hole Closure
| Study group | Role | What they receive |
|---|---|---|
| Double flap technique to secure macular hole closure. | Experimental | Single ILM flap technique is already performing worldwide; however, sometimes it is associated with flap displacement. To overcome this issue, the double flap technique was tried. Receives: Other: Surgical intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular coherence tomography
The closure of the hole can be assessed clearly
Measured: The fourth week post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start1 Jan 2022
- Primary completion23 Mar 2023
- Study completion23 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular HolesStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Omer Othman Abdullah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Omer Othman Abdullah, Ibinsina Modern Eye and Retina Center
- Investigators
- Omer Abdullah, M.Sc., Principal investigator, Ibinsina Modern Eye and Retina Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05269563
- Sponsor's protocol ID
- IMER 11
- Status last verified
- Mar 2023
- First submitted
- 28 Jan 2022
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Flap Technique Utilizing ERM and ILM for Macular Hole
- ClinicalTrials.gov ID
- NCT05269563
- Acronym / sponsor ID
- IMER 11
- Conditions
- Macular Holes
- Keywords
- Double Flaps
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Omer Othman AbdullahUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 23 Mar 2023 (actual)
- Study completion
- 23 Mar 2023 (actual)
- First posted
- 8 Mar 2022 (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.
Double flapping technique to close the macular hole.
Detailed description
Recently, it is agreed to close the macular hole with the retinal innermost layer; which is called internal limiting membrane (ILM), in most cases, the hole closes. But, sometimes the ILM single flap might displace resulting in a persistent hole.
Therefore, the investigators tried to make two flaps utilizing ILM, and sometimes certain patients have a very thin membrane over the retina; it is called epiretinal membrane (ERM). The investigators use the double flapping technique by utilizing ERM; therefore, the ILM remains and can be used if the hole resists closing with the first surgical interventions.
Here, the investigators did not use any new materials with unknown side effects on the human retina. Although the flap technique is well known; however, investigators are making a double flap to decrease the chance of persisting macular holes.
The visual recovery will be appeared in the post-operative period, whether it is the same, better, or worse.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Double flap technique to secure macular hole closure. | Experimental | Other: Surgical interventionSingle ILM flap technique is already performing worldwide; however, sometimes it is associated with flap displacement. To overcome this issue, the double flap technique was tried. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Full thickness macular hole
Key exclusion criteria (2 listed)
- Partial-thickness macular hole
- Vitreomacular traction
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 |
|---|---|---|
| Surgical interventionPars Plana Vitrectomy for Macular Hole Closure | Other | Double flap technique to secure macular hole closure. |
Primary outcome
Ocular coherence tomography
Time frame: The fourth week post-operatively
The closure of the hole can be assessed clearly
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 24 Mar 2023.
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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.
Omer Abdullah, M.Sc. principal investigator
Ibinsina Modern Eye and Retina Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical intervention in people with Macular Holes, run by Omer Othman Abdullah at 1 site in Iraq.
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 2 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 24 Mar 2023. 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 Iraq. 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?
Ocular coherence tomography (time frame: The fourth week post-operatively). 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 24 Mar 2023.