Macula HoleNCT03528122
Amniotic Membrane for Recurrent Macular Hole
A study testing Recurrent opened macular hole in people with Macula Hole and Retinal Detachment, run by Minia University at 1 site in Egypt.
Trial summary
Macular hole surgery were tried by different surgeons using many techniques with different successes but still there were many recurrences. In this study the investigators try to close these distinct types including recurrent holes using pre-prepared amniotic membrane. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Macula Hole, Retinal Detachment, Myopic Macular Degeneration
- What is being tested?
- Recurrent opened macular hole
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2018to 1 May 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
- Patient with history of opened macular hole after previous pars plana vitrectomy and internal limiting membrane (ILM) peeling for treatment of myopic macular hole were included.
- Opened holes after 1 month of the surgery.
- Myopic macular holes only were included (Refraction of more than _6 D and/or axial length of more than 26 mm).
Who cannot join
- All other causes of macular hole (traumatic and idiopathic)
- Patients with diseases that can affect visual outcome (Diabetic retinopathy, choroidal neovascularization, age-related macular disease and advanced glaucoma patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Safety and Efficacy of Using Amniotic Membrane for Closure of Recurrent Macular Hole
Macular hole surgery were tried by different surgeons using many techniques with different successes but still there were many recurrences. In this study the investigators try to close these distinct types including recurrent holes using pre-prepared amniotic membrane.
Read the detailed description
It is an interventional study of using amniotic membrane graft for closure of macular hole associated retinal detachment in patient who had a previous failed macular surgery.
- Conditions
- Macula Hole, Retinal Detachment, Myopic Macular Degeneration
- Being tested
- Recurrent opened macular hole
- Keywords
- amniotic membrane, retinal detachment, Myopic, macular hole, internal limiting membrane
- Medical subject headings
- Retinal Perforations, Retinal Detachment, Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recurrent opened macular holeProcedure or surgery
pars plana vitrectomy + internal limiting membrane peeling + Amniotic membrane graft placement over the hole + intraocular tamponade
| Study group | Role | What they receive |
|---|---|---|
| Recurrent opened macular hole | Experimental | Pars plana vitrectomy with internal limiting membrane peel if not peeled in the first surgery and application of amniotic membrane graft Receives: Procedure: Recurrent opened macular hole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anatomical restoration of macular hole closure
Closure of the macular hole
Measured: 6 months
Secondary outcomes (2)
Functional restoration after closure of the macular hole
Improvement of the best corrected visual acuity (BCVA)
Measured: 6 months
Functional restoration after closure of the macular hole
Any improvement of the waves in the electrophysiological (ERG) study.
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 posted17 May 2018
- Study start1 Feb 2018
- Primary completion1 May 2020 (estimated)
- Study completion1 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macula 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
- Not applicable
- Intervention model
- Single group
- Model description
- Individuals with recurrent macular hole associated retinal detachment
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hossam Mohamed Moharram, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03528122
- Sponsor's protocol ID
- 63 2/2018
- Status last verified
- Feb 2020
- First submitted
- 21 Apr 2018
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Using Amniotic Membrane for Closure of Recurrent Macular Hole
- ClinicalTrials.gov ID
- NCT03528122
- Acronym / sponsor ID
- 63 2/2018
- Conditions
- Macula Hole, Retinal Detachment, Myopic Macular Degeneration
- Keywords
- amniotic membrane, retinal detachment, Myopic, macular hole, internal limiting membrane
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 May 2020 (estimated)
- Study completion
- 1 May 2020 (estimated)
- First posted
- 17 May 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.
Macular hole surgery were tried by different surgeons using many techniques with different successes but still there were many recurrences. In this study the investigators try to close these distinct types including recurrent holes using pre-prepared amniotic membrane.
Detailed description
It is an interventional study of using amniotic membrane graft for closure of macular hole associated retinal detachment in patient who had a previous failed macular surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Individuals with recurrent macular hole associated retinal detachment
| Arm | Type | Receives |
|---|---|---|
| Recurrent opened macular hole | Experimental | Procedure: Recurrent opened macular holePars plana vitrectomy with internal limiting membrane peel if not peeled in the first surgery and application of amniotic membrane graft |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patient with history of opened macular hole after previous pars plana vitrectomy and internal limiting membrane (ILM) peeling for treatment of myopic macular hole were included.
- Opened holes after 1 month of the surgery.
- Myopic macular holes only were included (Refraction of more than _6 D and/or axial length of more than 26 mm).
Key exclusion criteria (2 listed)
- All other causes of macular hole (traumatic and idiopathic)
- Patients with diseases that can affect visual outcome (Diabetic retinopathy, choroidal neovascularization, age-related macular disease and advanced glaucoma patients.
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 |
|---|---|---|
| Recurrent opened macular holepars plana vitrectomy + internal limiting membrane peeling + Amniotic membrane graft placement over the hole + intraocular tamponade | Procedure or surgery | Recurrent opened macular hole |
Primary outcome
Anatomical restoration of macular hole closure
Time frame: 6 months
Closure of the macular hole
2 secondary outcomes
Functional restoration after closure of the macular hole
Time frame: 6 months
Functional restoration after closure of the macular hole
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- Individual participant dataSharing planned: Undecided
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 Recurrent opened macular hole in people with Macula Hole and Retinal Detachment, run by Minia 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 3 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: status not confirmed, as of the sponsor's last update on 20 Feb 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?
Results are not available in the source record.
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 restoration 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 20 Feb 2020; AzTrials last refreshed its copy on 29 Oct 2026.