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Foveal Cone Outer Segment Resumption to Predict Visual Recovery After Macular Hole Surgery

NCT ID: NCT01381965

Last Updated: 2012-08-02

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

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2011-02-28

Brief Summary

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Spectral domain optical coherence tomography (SD-OCT) was used to determine whether the repair of photoreceptor cone outer segment tips defect is significantly correlated with the visual outcomes after macular hole surgery.

Detailed Description

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Spectral domain optical coherence tomography (SD-OCT) was used to calculate the mean length of photoreceptor cone outer segment tips (COST) defect on 1, 3, 6, 9, and 12 months after macular hole surgery. The correlation between the mean length of COST defect and the BCVA was determined. Prognostic factors might have influenced for COST repair was also evaluated by multivariable analysis.

Conditions

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Macular Holes

Keywords

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spectral-domain optical coherence tomography idiopathic macular hole cone outer segment tips line vitrectomy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Eyes with macular hole

Group Type ACTIVE_COMPARATOR

Vitreous surgery for macular hole

Intervention Type PROCEDURE

Vitreous surgery for macular hole

Interventions

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Vitreous surgery for macular hole

Vitreous surgery for macular hole

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* macular hole patients with surgically-closed hole

Exclusion Criteria

* macular hole patients failed to close hole
* presence of retinal diseases including a treated rhegmatogenous retinal detachment, diabetic retinopathy, and high myopia with an axial length \>27.0mm or refractive error \> -8.0 diopters(D).
* patients who were not followed at least 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

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Makoto Inoue, MD

Role: PRINCIPAL_INVESTIGATOR

Kyorin Eye Center

Locations

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Makoto Inoue

Mitaka, Tokyo, Japan

Site Status

Countries

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Japan

Other Identifiers

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KYORIN-H21012

Identifier Type: OTHER

Identifier Source: secondary_id

Kyorineye006

Identifier Type: -

Identifier Source: org_study_id