NCT02905409

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
228

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2016

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 31, 2016

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 2, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 19, 2016

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

December 30, 2019

Status Verified

December 1, 2019

Enrollment Period

3.4 years

First QC Date

September 2, 2016

Last Update Submit

December 26, 2019

Conditions

Idiopathic Macular HoleSurgery

Outcome Measures

Primary Outcomes (2)

  • Anatomical closure grades in OCT

    The anatomical outcomes were defined as good closure and poor closure.

    6 months

  • Change of anatomical closure grades in OCT

    The anatomical outcomes were defined as good closure and poor closure.

    1 month, 3 months, 6 months, 1 year

Secondary Outcomes (1)

  • Change from baseline in BCVA (best corrected visual acuity).

    1 month, 3 months, 6 months, 1 year

Study Arms (2)

4PD diameter of ILM peeling in surgery

ACTIVE COMPARATOR

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

2PD diameter of ILM peeling in surgery

EXPERIMENTAL

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

Interventions

ILM peeling surgeryPROCEDURE

4PD or 2PD diameter of ILM peeling in surgery was given to patients with IMH (idiopathic macular hole)

2PD diameter of ILM peeling in surgery4PD diameter of ILM peeling in surgery

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with IMH
  • patients signed the ICF
  • patients with course of IMH less than 3 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

People's Hospital of Peking University

Beijing, Beijing Municipality, 100044, China

RECRUITING

Study Officials

  • Mingwei Zhao, M.D

    Peking University People's Hospital

    STUDY DIRECTOR

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mingwei Zhao, M.D

CONTACT

13801057408dr_mingweizhao@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Opthalmology Department, Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

September 2, 2016

First Posted

September 19, 2016

Study Start

August 31, 2016

Primary Completion

January 31, 2020

Study Completion

June 30, 2020

Last Updated

December 30, 2019

Record last verified: 2019-12

Locations

CN(1)