Inverted Internal Limiting Membrane Flap Technique for Macular Hole Retinal Detachment in Highly Myopic Eyes

NCT ID: NCT02896972

Last Updated: 2017-01-10

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

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2016-09-30

Brief Summary

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To evaluate efficacy of vitrectomy with inverted internal limiting membrane (ILM) flap technique for macular hole retinal detachment (MHRD) in highly myopic eyes, and to demonstrate postoperative clinical course of MHRD after inverted ILM flap technique using swept-source optical coherence tomography (OCT)

Detailed Description

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Macular hole retinal detachment (MHRD) threatens a certain number of highly myopic patients for irreversible visual dysfunction, and mostly requires immediate surgical intervention. The aim of they study is to evaluate efficacy of vitrectomy with inverted internal limiting membrane (ILM) flap technique for MHRD in highly myopic eyes, and to demonstrate postoperative clinical course of MHRD after inverted ILM flap technique using swept-source optical coherence tomography.

Conditions

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Macular Hole Retinal Detachment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Inverted ILM flap group

Eyes underwent vitrectomy with inverted internal limiting membrane technique

Group Type ACTIVE_COMPARATOR

Vitrectomy

Intervention Type PROCEDURE

Vitrectomy with inverted ILM technique or ILM peeling

ILM peeling group

Eyes underwent vitrectomy with internal limiting membrane peeling

Group Type ACTIVE_COMPARATOR

Vitrectomy

Intervention Type PROCEDURE

Vitrectomy with inverted ILM technique or ILM peeling

Interventions

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Vitrectomy

Vitrectomy with inverted ILM technique or ILM peeling

Intervention Type PROCEDURE

Eligibility Criteria

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Exclusion Criteria

* The patients with follow-up less than 6 months.
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kyorin University

OTHER

Sponsor Role lead

Responsible Party

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Makoto Inoue

Professor of Ophthalmology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Makoto Inoue, MD

Role: PRINCIPAL_INVESTIGATOR

Kyorin Eye Center

Other Identifiers

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Kyorineye022

Identifier Type: -

Identifier Source: org_study_id

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