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

NCT ID: NCT02930369

Last Updated: 2016-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-10-31

Brief Summary

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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).

Detailed Description

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Conditions

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Macular Hole

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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

Group Type ACTIVE_COMPARATOR

ILM peeling surgery

Intervention Type PROCEDURE

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

2PD diameter of ILM peeling in surgery

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

Group Type EXPERIMENTAL

ILM peeling surgery

Intervention Type PROCEDURE

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

Interventions

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ILM peeling surgery

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mingwei Zhao

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mingwei Zhao, M.D

Role: STUDY_DIRECTOR

Peking University People's Hospital

Other Identifiers

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DAILMP-CHINA

Identifier Type: -

Identifier Source: org_study_id

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