Evaluation of Vitrectomy With ILM Peeling in Myopic Macular Hole With Only Posterior Retinal Detachment
1 other identifier
interventional
13
1 country
1
Brief 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%.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedFirst Submitted
Initial submission to the registry
December 23, 2023
CompletedFirst Posted
Study publicly available on registry
January 8, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 15, 2024
CompletedJanuary 8, 2024
December 1, 2023
1.9 years
December 23, 2023
December 23, 2023
Conditions
Outcome Measures
Primary Outcomes (4)
Closure of macular hole
It is a subjective outcome measured by Optical coherence tomography and by clinical slit lamb examination
6 months post operative
BCVA
It is a measure of the visual acuity, which will be measured by LogMar
baseline
BCVA
It is a measure of the visual acuity, which will be measured by LogMar
6 months postoperative
BCVA
It is a measure of the visual acuity, which will be measured by LogMar
12 months postoperative
Study Arms (1)
myopic eyes with macular hole and only posterior retinal detachment
OTHERInterventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ehab tharwat
Damietta, New Damietta, 34517, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 23, 2023
First Posted
January 8, 2024
Study Start
January 1, 2022
Primary Completion
December 1, 2023
Study Completion
January 15, 2024
Last Updated
January 8, 2024
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share