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
• Interventions: Procedure: Large extent of ILM Peeling; Procedure: Small extent of ILM Peeling

• 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

Study Timeline

• Status Verified: 2019-01
• Study First Submitted: 2019-01-13
• Study First Submitted QC: 2019-01-13
• Last Update Submitted: 2019-01-13
• Study First Posted: 2019-01-16
• Last Update Posted: 2019-01-16
• Study Start: 2019-02-01
• Primary Completion: 2019-11-01
• Study Completion: 2020-01-31

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

Arm && Interventions

Group	Intervention	Description
Large extent of ILM Peeling	Large extent of ILM Peeling	Extent of ILM peeling is 4DD and the ILM flap is inserted
Small extent of ILM Peeling	Small extent of ILM Peeling	Extent of ILM peeling is 2DD and the ILM flap is inserted

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)