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

October 11, 2016 updated by: Mingwei Zhao, Peking University People's Hospital

A Randomized, Comparative, Prospective Study of Anatomical Outcomes With Different Internal Limiting Membrane Peeling Area in Surgery for Idiopathic Macular Hole

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

128

Phase

  • Phase 4

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

No older than 80 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 4PD diameter of ILM peeling in surgery
patients in this group was given 4papillary diameter (PD) diameter of internal limiting membrane (ILM) peeling in surgery
Procedure: ILM peeling surgery
4PD or 2PD diameter of ILM peeling in surgery was given to patients with idiopathic macular hole (IMH)
EXPERIMENTAL: 2PD diameter of ILM peeling in surgery
patients in this group was given 2PD diameter of ILM peeling in surgery
Procedure: ILM peeling surgery
4PD or 2PD diameter of ILM peeling in surgery was given to patients with idiopathic macular hole (IMH)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Anatomical closure grades in OCT
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Change of anatomical closure grades in OCT
Time Frame: 3 months, 6 months, 1 year
3 months, 6 months, 1 year
Change from baseline in BCVA (best corrected visual acuity)
Time Frame: 3 months, 6 months, 1 year
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

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

June 1, 2015

Primary Completion (ACTUAL)

October 1, 2016

Study Completion (ACTUAL)

October 1, 2016

Study Registration Dates

First Submitted

October 10, 2016

First Submitted That Met QC Criteria

October 11, 2016

First Posted (ESTIMATE)

October 12, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

October 12, 2016

Last Update Submitted That Met QC Criteria

October 11, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DAILMP-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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