Clinical Research on the Effect of Different Extents of Internal Limiting Membrane Peeling on Macular Hole Closure and Visual Acuity
Not Applicable
- Conditions
- Macular Holes
- Registration Number
- NCT03805763
- Lead Sponsor
- Wenzhou Medical University
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
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;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Mean change from baseline in best-corrected visual acuity (BCVA) 1 year Assessed using the ETDRS protocol
change from baseline in foveal avascular zone (FAZ) areas and diameter 1 year Assessed on AngioOCT
change from baseline in the area and diameter of deteriorated circulation zone in superficial and deep retina vessels 1 year Assessed on AngioOCT
Condition of postoperative healing of macular holes 1 year postoperative photograph of macular retina scanned by Angiography Optical Coherence Tomography(AngioOCT)
- Secondary Outcome Measures
Name Time Method