NCT02930369

Brief Summary

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).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
128

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2015

Status
completed

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

June 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

October 10, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 12, 2016

Completed
Last Updated

October 12, 2016

Status Verified

October 1, 2016

Enrollment Period

1.3 years

First QC Date

October 10, 2016

Last Update Submit

October 11, 2016

Conditions

Macular Hole

Outcome Measures

Primary Outcomes (1)

  • Anatomical closure grades in OCT

    1 year

Secondary Outcomes (2)

  • Change of anatomical closure grades in OCT

    3 months, 6 months, 1 year

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

    3 months, 6 months, 1 year

Study Arms (2)

4PD diameter of ILM peeling in surgery

ACTIVE COMPARATOR

patients in this group was given 4papillary diameter (PD) diameter of internal limiting membrane (ILM) peeling in surgery

Procedure: ILM peeling surgery

2PD diameter of ILM peeling in surgery

EXPERIMENTAL

patients in this group was given 2PD diameter of ILM 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 idiopathic macular hole (IMH)

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

Eligibility Criteria

AgeUp to 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients with IMH
  • patients signed the informed consent form (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

MeSH Terms

Conditions

Retinal Perforations

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Study Officials

  • Mingwei Zhao, M.D

    Peking University People's Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

October 10, 2016

First Posted

October 12, 2016

Study Start

June 1, 2015

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

October 12, 2016

Record last verified: 2016-10