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

Sponsor
Peking University People's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02930369
Collaborator
(none)
128
Enrollment
2
Arms
16
Duration (Months)

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Procedure: ILM peeling surgery
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
128 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized, Comparative, Prospective Study of Anatomical Outcomes With Different Internal Limiting Membrane Peeling Area in Surgery for Idiopathic Macular Hole
Study Start Date :
Jun 1, 2015
Actual Primary Completion Date :
Oct 1, 2016
Actual Study Completion Date :
Oct 1, 2016

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

  1. Anatomical closure grades in OCT [1 year]

Secondary Outcome Measures

  1. Change of anatomical closure grades in OCT [3 months, 6 months, 1 year]

  2. Change from baseline in BCVA (best corrected visual acuity) [3 months, 6 months, 1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Peking University People's Hospital

Investigators

  • Study Director: Mingwei Zhao, M.D, Peking University People's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mingwei Zhao, Dr., Peking University People's Hospital
ClinicalTrials.gov Identifier:
NCT02930369
Other Study ID Numbers:
  • DAILMP-CHINA
First Posted:
Oct 12, 2016
Last Update Posted:
Oct 12, 2016
Last Verified:
Oct 1, 2016
Additional relevant MeSH terms:
Retinal Perforations

Study Results

No Results Posted as of Oct 12, 2016