Clinical Research on the Effect of Different Extents of Internal Limiting Membrane Peeling on Macular Hole Closure and Visual Acuity

Observing and describing the surgical effects of different extents of internal limiting membrane peeling combined with internal limiting membrane insertion for macular hole

Study Overview

• Status: Unknown
• Conditions: Macular Holes
• Intervention / Treatment: Procedure: Large extent of ILM Peeling; Procedure: Small extent of ILM Peeling

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Large extent of ILM Peeling; Extent of ILM peeling is 4DD and the ILM flap is inserted	Procedure: Large extent of ILM Peeling; The extent of ILM peeling is 4DD
Experimental: Small extent of ILM Peeling; Extent of ILM peeling is 2DD and the ILM flap is inserted	Procedure: Small extent of ILM Peeling; The extent of ILM peeling is 2DD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Wenzhou Medical University
• Investigators: Principal Investigator: Zongduan Zhang, M.D,PhD, The Eye Hospital of Wenzhou Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2019
• Primary Completion (Anticipated): November 1, 2019
• Study Completion (Anticipated): January 31, 2020

Study Registration Dates

• First Submitted: January 13, 2019
• First Submitted That Met QC Criteria: January 13, 2019
• First Posted (Actual): January 16, 2019

Study Record Updates

• Last Update Posted (Actual): January 16, 2019
• Last Update Submitted That Met QC Criteria: January 13, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Perforations
• Other Study ID Numbers: ZZD-Macular Hole

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No