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Clinical Trials/NCT02930369
NCT02930369CompletedPhase 4

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

Peking University People's Hospital0 sites128 target enrollmentStarted: June 1, 2015Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
128
Primary Endpoint
Anatomical closure grades in OCT
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
— to 80 Years (Child, Adult, Older Adult)
Sex
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

Arms & Interventions

2PD diameter of ILM peeling in surgery

Experimental

patients in this group was given 2PD diameter of ILM peeling in surgery

Intervention: ILM peeling surgery (Procedure)

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

Intervention: ILM peeling surgery (Procedure)

Outcomes

Primary Outcomes

Anatomical closure grades in OCT

Time Frame: 1 year

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mingwei Zhao

Dr.

Peking University People's Hospital

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