Retinal DetachmentNCT06194760
Evaluation of Vitrectomy With ILM Peeling in Myopic Macular Hole With Only Posterior Retinal Detachment
A study testing Vitrectomy with ILM peeling in people with Retinal Detachment, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Retinal detachment (RD) resulting from the macular hole (MH), also known as MH-induced RD (MHRD), most commonly occurs in eyes with high myopia and results in irreversible visual disorders. Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Retinal Detachment
- What is being tested?
- Vitrectomy with ILM peeling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 15 Jan 2024
- 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 15 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- patients with high myopia (a spherical equivalent refractive error of at least -6.0 diopters (D) and an axial length of at least 26.5 mm).
- Macular hole and only posterior retinal detachment
Who cannot join
- Other causes of RD
- Patients with a history of trauma, choroidal neovascularization, coexistence with a peripheral retinal break or proliferative vitreoretinopathy
- History of any vitreoretinal surgery prior to MHRD and less than 36 months of follow-up after the surgery
Trial locations and contacts
1 site in 1 country.
About this study
Retinal detachment (RD) resulting from the macular hole (MH), also known as MH-induced RD (MHRD), most commonly occurs in eyes with high myopia and results in irreversible visual disorders. Although ILM peeling for MHRD reportedly achieves a high retinal reattachment rate that ranges from 70% to 100%, the MH closure rate is relatively low, ranging from 10% to 70%.
- Conditions
- Retinal Detachment
- Being tested
- Vitrectomy with ILM peeling
- Medical subject headings
- Retinal Detachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitrectomy with ILM peelingProcedure or surgery
Vitrectomy with traditional internal limiting membrane (ILM) peeling technique is regarded as the gold standard treatment for MH; it works by completely relieving of the traction of the macula and increasing the flexibility of the retina
| Study group | Role | What they receive |
|---|---|---|
| myopic eyes with macular hole and only posterior retinal detachment | Other | Not described Receives: Procedure: Vitrectomy with ILM peeling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Closure of macular hole
It is a subjective outcome measured by Optical coherence tomography and by clinical slit lamb examination
Measured: 6 months post operative
BCVA
It is a measure of the visual acuity, which will be measured by LogMar
Measured: baseline
BCVA
It is a measure of the visual acuity, which will be measured by LogMar
Measured: 6 months postoperative
BCVA
It is a measure of the visual acuity, which will be measured by LogMar
Measured: 12 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start1 Jan 2022
- Primary completion1 Dec 2023
- Study completion15 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal DetachmentStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe 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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ehab Tharwat, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06194760
- Sponsor's protocol ID
- Vitrectomy with ILM peeling
- Status last verified
- Dec 2023
- First submitted
- 23 Dec 2023
- Last updated
- 8 Jan 2024
- 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 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Vitrectomy With ILM Peeling in Myopic Macular Hole With Only Posterior Retinal Detachment
- ClinicalTrials.gov ID
- NCT06194760
- Acronym / sponsor ID
- Vitrectomy with ILM peeling
- Conditions
- Retinal Detachment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 15 Jan 2024 (estimated)
- First posted
- 8 Jan 2024 (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.
Retinal detachment (RD) resulting from the macular hole (MH), also known as MH-induced RD (MHRD), most commonly occurs in eyes with high myopia and results in irreversible visual disorders. Although ILM peeling for MHRD reportedly achieves a high retinal reattachment rate that ranges from 70% to 100%, the MH closure rate is relatively low, ranging from 10% to 70%.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| myopic eyes with macular hole and only posterior retinal detachment | Other | Procedure: Vitrectomy with ILM peeling |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- patients with high myopia (a spherical equivalent refractive error of at least -6.0 diopters (D) and an axial length of at least 26.5 mm).
- Macular hole and only posterior retinal detachment
Key exclusion criteria (3 listed)
- Other causes of RD
- Patients with a history of trauma, choroidal neovascularization, coexistence with a peripheral retinal break or proliferative vitreoretinopathy
- History of any vitreoretinal surgery prior to MHRD and less than 36 months of follow-up after the surgery
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 |
|---|---|---|
| Vitrectomy with ILM peelingVitrectomy with traditional internal limiting membrane (ILM) peeling technique is regarded as the gold standard treatment for MH; it works by completely relieving of the traction of the macula and increasing the flexibility of the retina | Procedure or surgery | myopic eyes with macular hole and only posterior retinal detachment |
Primary outcome
Closure of macular hole
Time frame: 6 months post operative
It is a subjective outcome measured by Optical coherence tomography and by clinical slit lamb examination
BCVA
Time frame: baseline
It is a measure of the visual acuity, which will be measured by LogMar
BCVA
Time frame: 6 months postoperative
It is a measure of the visual acuity, which will be measured by LogMar
BCVA
Time frame: 12 months postoperative
It is a measure of the visual acuity, which will be measured by LogMar
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2024.
- Individual participant dataSharing planned: No
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RecruitingObservational study
Surgical Procedure Efficiency Evaluation stuDy
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RecruitingPhase 3
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Recruiting
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Stickler Syndrome Type 1, Stickler Syndrome Type 2
RecruitingObservational study
Intraoperative OCT Guidance of Intraocular Surgery II
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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 Vitrectomy with ILM peeling in people with Retinal Detachment, run by Al-Azhar 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 2 inclusion and 3 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 8 Jan 2024. 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?
Closure of macular hole (time frame: 6 months post operative). The study lists 4 primary outcomes in all. 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 8 Jan 2024.