ClinicalTrials.gg
Active, not recruitingNCT06194760Updated Jan 8, 2024

Evaluation of Vitrectomy With ILM Peeling in Myopic Macular Hole With Only Posterior Retinal Detachment

An interventional study of Vitrectomy with ILM peeling in Retinal Detachment, sponsored by Al-Azhar University. Active, not recruiting at 1 site in Egypt. Open to participants aged 15 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-01-08.

Sponsored by Al-Azhar University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 11 months after the study started (first participant enrolled Jan 2022, registered Dec 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
13
Allocation
Not applicable
Ages
15 Years to 60 Years
Sex
All
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Study 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. 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%.

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Conditions studied

  • Retinal Detachment

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03

In context

Retinal Detachment

199 studies on the registry are indexed under Retinal Detachment; 29 are open to participants now.

This study's enrollment of 13 is below the median of 50 across 132 interventional studies indexed under Retinal Detachment.

Browse Retinal Detachment studies →

Lead sponsor

Al-Azhar University is the lead sponsor of 531 studies on the registry; 172 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
15 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
13 participants (actual)

Study arms

  • Other
    myopic eyes with macular hole and only posterior retinal detachment

    Procedure: Vitrectomy with ILM peeling

Interventions

  • ProcedureVitrectomy with ILM peeling

    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

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What researchers measure

Primary outcomes

  1. Closure of macular hole

    It is a subjective outcome measured by Optical coherence tomography and by clinical slit lamb examination

    Time frame: 6 months post operative

  2. BCVA

    It is a measure of the visual acuity, which will be measured by LogMar

    Time frame: baseline

  3. BCVA

    It is a measure of the visual acuity, which will be measured by LogMar

    Time frame: 6 months postoperative

  4. BCVA

    It is a measure of the visual acuity, which will be measured by LogMar

    Time frame: 12 months postoperative

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Study locations

1 site
  • Ehab tharwat
    Damieta, New Damietta 34517, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06194760
Responsible party
Ehab Tharwat (Principal Investigator, Al-Azhar University) — Principal investigator
First posted
Jan 8, 2024
Start date
Jan 1, 2022
Primary completion
Dec 1, 2023
Completion
Jan 15, 2024 (estimated)
Last update
Jan 8, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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