Study of Surgery in Patients With Idiopathic Macular Hole

Peking University

Status and phase: Unknown; Phase 4

Conditions: Surgery; Idiopathic Macular Hole

Treatments: Procedure: ILM peeling surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT02905409

ILMIMH-CHINA

Details and patient eligibility

About

The purpose of this study is to determine the effects of two different internal limiting membrane peeling with distinct diameters after macular hole surgery on anatomical closure grades.

Full description

The purpose of this study is to investigate two distinct diameter of internal limiting membrane peeling on anatomical outcomes of macular hole surgery with different preoperative idiopathic macular hole.

Enrollment: 228 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with IMH
• patients signed the 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: Triple Blind

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228 participants in 2 patient groups

4PD diameter of ILM peeling in surgery

Active Comparator group

Description:

Patients were stratified according to the macular hole closure index(MHCI) measured by OCT into 3 subgroup (MHCI\<0.5, 0.5≤MHCI\<0.7, MHCI≥0.7 ). And then randomized into 2 different intervention groups. If randomized into 4PD (papillary diameter) group, patients were given 4PD diameter of ILM (internal limiting membrane) peeling in surgery.

Treatment:

Procedure: ILM peeling surgery

2PD diameter of ILM peeling in surgery

Experimental group

Description:

Patients were stratified according to the macular hole closure index(MHCI) measured by OCT into 3 subgroup (MHCI\<0.5, 0.5≤MHCI\<0.7, MHCI≥0.7 ). And then randomized into 2 different intervention groups. If randomized into 2PD (papillary diameter) group, patients were given 2PD diameter of ILM (internal limiting membrane) peeling in surgery.

Treatment:

Procedure: ILM peeling surgery