Study of Surgery in Patients With Idiopathic Macular Hole

Phase 4

• Conditions: Idiopathic Macular Hole; Surgery
• Interventions: Procedure: ILM peeling surgery

• Registration Number: NCT02905409
• 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 peeling with distinct diameters after macular hole surgery on anatomical closure grades.

Detailed 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.

Study Timeline

• Study Start: 2016-08-31
• Study First Submitted: 2016-09-02
• Study First Submitted QC: 2016-09-13
• Study First Posted: 2016-09-19
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-26
• Last Update Posted: 2019-12-30
• Primary Completion: 2020-01-31
• Study Completion: 2020-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 228

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2PD diameter of ILM peeling in surgery	ILM peeling surgery	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.
4PD diameter of ILM peeling in surgery	ILM peeling surgery	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.

Primary Outcome Measures

Name	Time	Method
Anatomical closure grades in OCT	6 months	The anatomical outcomes were defined as good closure and poor closure.
Change of anatomical closure grades in OCT	1 month, 3 months, 6 months, 1 year	The anatomical outcomes were defined as good closure and poor closure.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in BCVA (best corrected visual acuity).	1 month, 3 months, 6 months, 1 year	BCVA were measured by ETDRS chart.

Trial Locations

Locations (1)

People's Hospital of Peking University; 🇨🇳 Beijing, Beijing, China