Clinical Research on the Effect of Different Extents of Internal Limiting Membrane Peeling on Macular Hole Closure and Visual Acuity
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Wenzhou Medical University
- Enrollment
- 60
- Primary Endpoint
- Mean change from baseline in best-corrected visual acuity (BCVA)
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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;
Exclusion Criteria
- •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;
Arms & Interventions
Large extent of ILM Peeling
Extent of ILM peeling is 4DD and the ILM flap is inserted
Intervention: Large extent of ILM Peeling (Procedure)
Small extent of ILM Peeling
Extent of ILM peeling is 2DD and the ILM flap is inserted
Intervention: Small extent of ILM Peeling (Procedure)
Outcomes
Primary Outcomes
Mean change from baseline in best-corrected visual acuity (BCVA)
Time Frame: 1 year
Assessed using the ETDRS protocol
change from baseline in foveal avascular zone (FAZ) areas and diameter
Time Frame: 1 year
Assessed on AngioOCT
change from baseline in the area and diameter of deteriorated circulation zone in superficial and deep retina vessels
Time Frame: 1 year
Assessed on AngioOCT
Condition of postoperative healing of macular holes
Time Frame: 1 year
postoperative photograph of macular retina scanned by Angiography Optical Coherence Tomography(AngioOCT)
Secondary Outcomes
No secondary outcomes reported
Investigators
Xiangtian Zhou
Professor
Wenzhou Medical University