Study of Surgery in Patients With Idiopathic Macular Hole

December 26, 2019 updated by: Mingwei Zhao, Peking University People's Hospital

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

228

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100044
        • Recruiting
        • People's Hospital of Peking University
        • Contact:
        • Principal Investigator:
          • Youxin Chen, M.D
        • Principal Investigator:
          • Wenbin Wei, M.D
        • Principal Investigator:
          • Hong Dai, M.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 4PD diameter of ILM 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 4PD (papillary diameter) group, patients were given 4PD diameter of ILM (internal limiting membrane) peeling in surgery.
Procedure: ILM peeling surgery
4PD or 2PD diameter of ILM peeling in surgery was given to patients with IMH (idiopathic macular hole)
Experimental: 2PD diameter of ILM 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.
Procedure: ILM peeling surgery
4PD or 2PD diameter of ILM peeling in surgery was given to patients with IMH (idiopathic macular hole)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anatomical closure grades in OCT
Time Frame: 6 months
The anatomical outcomes were defined as good closure and poor closure.
6 months
Change of anatomical closure grades in OCT
Time Frame: 1 month, 3 months, 6 months, 1 year
The anatomical outcomes were defined as good closure and poor closure.
1 month, 3 months, 6 months, 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in BCVA (best corrected visual acuity).
Time Frame: 1 month, 3 months, 6 months, 1 year
BCVA were measured by ETDRS chart.
1 month, 3 months, 6 months, 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University People's Hospital

Collaborators

Peking Union Medical College Hospital
Beijing Tongren Hospital
Beijing Hospital

Investigators

  • Principal Investigator: Hong Dai, M.D, Peking Union Medical College
  • Principal Investigator: Wenbin Wei, M.D, Beijing Tongren Hospital of Capital Medical University
  • Principal Investigator: Youxin Chen, M.D, Peking Union Medical College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2016

Primary Completion (Anticipated)

January 31, 2020

Study Completion (Anticipated)

June 30, 2020

Study Registration Dates

First Submitted

September 2, 2016

First Submitted That Met QC Criteria

September 13, 2016

First Posted (Estimate)

September 19, 2016

Study Record Updates

Last Update Posted (Actual)

December 30, 2019

Last Update Submitted That Met QC Criteria

December 26, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ILMIMH-CHINA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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