search
Back to results

Study of Surgery in Patients With Idiopathic Macular Hole

Primary Purpose

Idiopathic Macular Hole, Surgery

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
ILM peeling surgery
Sponsored by
Peking University People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Macular Hole

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • People's Hospital of Peking UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

4PD diameter of ILM peeling in surgery

2PD diameter of ILM peeling in surgery

Arm 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.

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.

Outcomes

Primary Outcome Measures

Anatomical closure grades in OCT
The anatomical outcomes were defined as good closure and poor closure.
Change of anatomical closure grades in OCT
The anatomical outcomes were defined as good closure and poor closure.

Secondary Outcome Measures

Change from baseline in BCVA (best corrected visual acuity).
BCVA were measured by ETDRS chart.

Full Information

First Posted
September 2, 2016
Last Updated
December 26, 2019
Sponsor
Peking University People's Hospital
Collaborators
Beijing Tongren Hospital, Beijing Hospital, Peking Union Medical College Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02905409
Brief Title
Study of Surgery in Patients With Idiopathic Macular Hole
Official Title
A Randomized, Double-masked, Multicenter, Controlled Study of Effects of Internal Membrane Peeling Surgery in Patients With Idiopathic Macular Hole Measured by Optical Coherence Tomography.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 31, 2016 (Actual)
Primary Completion Date
January 31, 2020 (Anticipated)
Study Completion Date
June 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University People's Hospital
Collaborators
Beijing Tongren Hospital, Beijing Hospital, Peking Union Medical College Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Macular Hole, Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
228 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
4PD diameter of ILM peeling in surgery
Arm Type
Active Comparator
Arm 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.
Arm Title
2PD diameter of ILM peeling in surgery
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
ILM peeling surgery
Intervention Description
4PD or 2PD diameter of ILM peeling in surgery was given to patients with IMH (idiopathic macular hole)
Primary Outcome Measure Information:
Title
Anatomical closure grades in OCT
Description
The anatomical outcomes were defined as good closure and poor closure.
Time Frame
6 months
Title
Change of anatomical closure grades in OCT
Description
The anatomical outcomes were defined as good closure and poor closure.
Time Frame
1 month, 3 months, 6 months, 1 year
Secondary Outcome Measure Information:
Title
Change from baseline in BCVA (best corrected visual acuity).
Description
BCVA were measured by ETDRS chart.
Time Frame
1 month, 3 months, 6 months, 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mingwei Zhao, M.D
Phone
13801057408
Email
dr_mingweizhao@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mingwei Zhao, M.D
Organizational Affiliation
Peking University People's Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hong Dai, M.D
Organizational Affiliation
Peking Union Medical College
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wenbin Wei, M.D
Organizational Affiliation
Beijing Tongren Hospital of Capital Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Youxin Chen, M.D
Organizational Affiliation
Peking Union Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
People's Hospital of Peking University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Minwei Zhao, M.D
Phone
13801057408
Email
dr_mingweizhao@163.com
First Name & Middle Initial & Last Name & Degree
Youxin Chen, M.D
First Name & Middle Initial & Last Name & Degree
Wenbin Wei, M.D
First Name & Middle Initial & Last Name & Degree
Hong Dai, M.D

12. IPD Sharing Statement

Learn more about this trial

Study of Surgery in Patients With Idiopathic Macular Hole

We'll reach out to this number within 24 hrs