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

Peking University

Status and phase: Completed; Phase 4

Conditions: Macular Hole

Treatments: Procedure: ILM peeling surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT02930369

DAILMP-CHINA

Details and patient eligibility

About

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).

Enrollment: 128 patients

Sex: All

Ages: Under 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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128 participants in 2 patient groups

4PD diameter of ILM peeling in surgery

Active Comparator group

Description:

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

Treatment:

Procedure: ILM peeling surgery

2PD diameter of ILM peeling in surgery

Experimental group

Description:

patients in this group was given 2PD diameter of ILM peeling in surgery

Treatment:

Procedure: ILM peeling surgery