Clinical Research on the Effect of Different Extents of Internal Limiting Membrane Peeling on Macular Hole Closure and Visual Acuity
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
Observing and describing the surgical effects of different extents of internal limiting membrane peeling combined with internal limiting membrane insertion for macular hole
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2019
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
First Submitted
Initial submission to the registry
January 13, 2019
CompletedFirst Posted
Study publicly available on registry
January 16, 2019
CompletedStudy Start
First participant enrolled
February 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2020
CompletedJanuary 16, 2019
January 1, 2019
9 months
January 13, 2019
January 13, 2019
Conditions
Outcome Measures
Primary Outcomes (4)
Condition of postoperative healing of macular holes
postoperative photograph of macular retina scanned by Angiography Optical Coherence Tomography(AngioOCT)
1 year
Mean change from baseline in best-corrected visual acuity (BCVA)
Assessed using the ETDRS protocol
1 year
change from baseline in foveal avascular zone (FAZ) areas and diameter
Assessed on AngioOCT
1 year
change from baseline in the area and diameter of deteriorated circulation zone in superficial and deep retina vessels
Assessed on AngioOCT
1 year
Study Arms (2)
Large extent of ILM Peeling
EXPERIMENTALExtent of ILM peeling is 4DD and the ILM flap is inserted
Small extent of ILM Peeling
EXPERIMENTALExtent of ILM peeling is 2DD and the ILM flap is inserted
Interventions
Eligibility Criteria
You may qualify if:
- Clear diagnosis of macular hole;
- The minimum diameter of the macular hole is \>400 μm;
- Without serious systemic disease that make patients can not be operated;
You may not qualify if:
- suffering from severe retinal diseases such as: diabetic retinopathy, age-related macular degeneration, peripheral retinal detachment, PVR, etc.;
- opacitas in the refractive medium can not perform Angio-OCT and visual acuity examination;
- eye acute and chronic inflammation, such as acute contagious conjunctivitis, acute and chronic keratitis, acute dacryocystitis;
- traumatic macular hole, secondary macular hole, high myopia macular hole, etc.;
- having a history of vitrectomy surgery;
- glaucoma in stage of preclinical, severe stenosis or closure;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zongduan Zhang, M.D,PhD
The Eye Hospital of Wenzhou Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 13, 2019
First Posted
January 16, 2019
Study Start
February 1, 2019
Primary Completion
November 1, 2019
Study Completion
January 31, 2020
Last Updated
January 16, 2019
Record last verified: 2019-01