OphthalmopathyNCT05494242
Single Superior ILM/ERM Flap for the FTMH.
A study testing Surgical intervention in people with Ophthalmopathy, run by Omer Othman Abdullah at 1 site in Iraq.
Trial summary
In this study, the investigators will make the only upper flap either from the internal limiting membrane or from the epiretinal membrane to cover the full thickness macular hole. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Ophthalmopathy
- What is being tested?
- Surgical intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteIraq
- Study dates
- 1 Sep 2022to 21 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Full thickness macular hole
Who cannot join
- Lamellar and pseudo holes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Superior Internal Limiting Membrane/Epiretinal Membrane Flap for the Full Thickness Macular Hole
In this study, the investigators will make the only upper flap either from the internal limiting membrane or from the epiretinal membrane to cover the full thickness macular hole.
Read the detailed description
After the investigators completed the clinical trial NCT05269563, which was a double flap technique; that consists of two flaps from the internal limiting membrane and the epiretinal membrane. The inferior flap was implanted inside the hole, but the upper flap was utilized to cover the hole. The results were encouraging. Therefore, in this study, the investigators will make the only upper flap to cover the full thickness macular hole, to compare both visual and anatomical outcomes with the double flapped technique (NCT05269563) results. Therefore the double flap will be our control.
- Conditions
- Ophthalmopathy
- Being tested
- Surgical intervention
- Keywords
- Full thickness macular hole, Epiretinal membrane, Internal limiting membrane, Flap
- Medical subject headings
- Eye Diseases, Epiretinal Membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical interventionOther
Pars-plana vitrectomy.
| Study group | Role | What they receive |
|---|---|---|
| single superior flap technique to secure macular hole closure. | Experimental | The patients are divided into two groups:
For the first group, the flap will be carried out under the effect of perfluorocarbon.
For the second group, the flap stabilized with methylcellulose. Receives: Other: Surgical intervention |
| Double flap technique to secure macular hole closure. | Active comparator | This arm is NCT05269563, we utilize the results as a comparator to the superior single flap technique. Receives: Other: Surgical intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anatomical outcome
OCT
Measured: The fourth weeks post-operatively
Secondary outcomes (1)
Functional outcome
Best corrected visual acuity
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 posted9 Aug 2022
- Study start1 Sep 2022
- Primary completion21 Mar 2023
- Study completion21 Mar 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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Omer Othman Abdullah
- Sponsor type
- University, hospital or other
- Collaborators
- Ibinsina Modern Eye and Retina Center
- Responsible party
- Sponsor-investigator, Omer Othman Abdullah, Ibinsina Modern Eye and Retina Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05494242
- Sponsor's protocol ID
- IMER 99
- Status last verified
- Mar 2023
- First submitted
- 6 Aug 2022
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Both the best corrected visual acuity and the OCT.
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
- Single Superior Internal Limiting Membrane/Epiretinal Membrane Flap for the Full Thickness Macular Hole
- ClinicalTrials.gov ID
- NCT05494242
- Acronym / sponsor ID
- IMER 99
- Conditions
- Ophthalmopathy
- Keywords
- Full thickness macular hole, Epiretinal membrane, Internal limiting membrane, Flap
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Omer Othman AbdullahUniversity, hospital or other
- Collaborators
- Ibinsina Modern Eye and Retina Center
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 21 Mar 2023 (actual)
- Study completion
- 21 Mar 2023 (actual)
- First posted
- 9 Aug 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.
In this study, the investigators will make the only upper flap either from the internal limiting membrane or from the epiretinal membrane to cover the full thickness macular hole.
Detailed description
After the investigators completed the clinical trial NCT05269563, which was a double flap technique; that consists of two flaps from the internal limiting membrane and the epiretinal membrane. The inferior flap was implanted inside the hole, but the upper flap was utilized to cover the hole. The results were encouraging. Therefore, in this study, the investigators will make the only upper flap to cover the full thickness macular hole, to compare both visual and anatomical outcomes with the double flapped technique (NCT05269563) results. Therefore the double flap will be our control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| single superior flap technique to secure macular hole closure. | Experimental | Other: Surgical interventionThe patients are divided into two groups: For the first group, the flap will be carried out under the effect of perfluorocarbon. For the second group, the flap stabilized with methylcellulose. |
| Double flap technique to secure macular hole closure. | Active comparator | Other: Surgical interventionThis arm is NCT05269563, we utilize the results as a comparator to the superior single flap technique. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Full thickness macular hole
Key exclusion criteria (1 listed)
- Lamellar and pseudo holes
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. | Other | Double flap technique to secure macular hole closure., single superior flap technique to secure macular hole closure. |
Primary outcome
Anatomical outcome
Time frame: The fourth weeks post-operatively
OCT
1 secondary outcome
Functional outcome
Time frame: The fourth week post-operatively.
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.
- Individual participant dataSharing planned: Yes. Both the best corrected visual acuity and the OCT.
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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 Surgical intervention in people with Ophthalmopathy, 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 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 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?
Anatomical outcome (time frame: The fourth weeks 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.