Effects of Different Area of Internal Limiting Membrane Peeling (ILM) Peeling on Anatomical Outcomes in Macular Hole Surgery

Phase 4

Completed

• Conditions: Macular Hole
• Interventions: Procedure: ILM peeling surgery

• Registration Number: NCT02930369
• Lead Sponsor: Peking University People's Hospital

Brief Summary

The purpose of this study is to determine the effects of two different internal limiting membrane (ILM) peeling area on anatomical closure outcomes after macular hole surgery measured by optical coherence tomography (OCT).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Status Verified: 2016-10
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Study First Submitted: 2016-10-10
• Study First Submitted QC: 2016-10-11
• Last Update Submitted: 2016-10-11
• Study First Posted: 2016-10-12
• Last Update Posted: 2016-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

• patients with IMH
• patients signed the informed consent form (ICF)
• patients with course of IMH less than 3 years

Exclusion Criteria

• patients with hyper myopia
• patients with traumatic macular hole
• accompanied or secondary of other fundus disease
• open or reopen after receiving MH surgery
• patients with retinal detachment
• received vitrectomy due to other diseases
• glaucoma cannot be controled by medication
• patients with other retinal or choroidal disease that may affect VA
• poor patients compliance
• poor condition that cannot undertake the surgery
• dioptric media opacities which make it difficult to exam fundus or measure on OCT

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4PD diameter of ILM peeling in surgery	ILM peeling surgery	patients in this group was given 4papillary diameter (PD) diameter of internal limiting membrane (ILM) peeling in surgery
2PD diameter of ILM peeling in surgery	ILM peeling surgery	patients in this group was given 2PD diameter of ILM peeling in surgery

Primary Outcome Measures

Name	Time	Method
Anatomical closure grades in OCT	1 year

Secondary Outcome Measures

Name	Time	Method
Change of anatomical closure grades in OCT	3 months, 6 months, 1 year
Change from baseline in BCVA (best corrected visual acuity)	3 months, 6 months, 1 year