Optical Coherence Tomography-based Positioning for Macular Hole Surgery

NCT ID: NCT02650739

Last Updated: 2016-01-08

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

Total Enrollment

125 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-31

Study Completion Date

2015-10-31

Brief Summary

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The efficacy of macular hole (MH) surgery with the halting of prone positioning by monitoring the MH closure in the swept source optical coherence tomographic (SS-OCT) images was compared with the surgery by the surgeon's decision. The macular hole closure and visual outcome were compared.

Detailed Description

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The efficacy of macular hole (MH) surgery with the halting of prone positioning by monitoring the MH closure in the swept source optical coherence tomographic (SS-OCT) images was compared with the surgery by the surgeon's decision. All eyes were treated by pars plana vitrectomy, internal limiting membrane peeling, and gas tamponade. MH closure was defined as a connection of the edges of the sensory retina in the SS-OCT images.The macular hole closure and visual outcome were compared.

Conditions

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Macular Hole Surgery

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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SS-OCTdetermined group

Eyes with macular hole surgery that the postoperative prone positioning was discontinued after detecting a closure by SS-OCT

Macular hole surgery

Intervention Type PROCEDURE

Vitrectomy with internal limiting membrane removal and gas tamponade

Control group

Eyes with macular hole surgery that the halting of the prone position was determined by the surgeon

Macular hole surgery

Intervention Type PROCEDURE

Vitrectomy with internal limiting membrane removal and gas tamponade

Interventions

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Macular hole surgery

Vitrectomy with internal limiting membrane removal and gas tamponade

Intervention Type PROCEDURE

Other Intervention Names

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Vitrectomy

Eligibility Criteria

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Inclusion Criteria

* The patients were followed more than 2 months.

Exclusion Criteria

* Eye with axial length more than 26.0 mm
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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Kyorineye0021

Identifier Type: -

Identifier Source: org_study_id

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