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Observation of Recovery of Foveal Cone Microstructures After Macular Hole Surgery

NCT ID: NCT01306487

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

Total Enrollment

58 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-03-31

Study Completion Date

2010-08-31

Brief Summary

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The objective is to determine whether a recovery of the microstructures of the foveal photoreceptors after macular hole (MH) closure is correlated with the best-corrected visual acuity (BCVA) is determined.

Detailed Description

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Macular hole patients were evaluated by spectral domain optical coherence tomography (SD-OCT) to determine the integrity of the microstructures of the foveal photoreceptors. The inner segment/outer segment (IS/OS) junction, the external limiting membrane (ELM), and the cone outer segment tips (COST) line were determined preoperatively, and at 1, 3, 6, 9, and 12 months after the MH surgery. The correlation between the integrity of the foveal photoreceptor microstructures and the best-corrected visual acuity (BCVA) was determined.

Conditions

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Macular Holes

Keywords

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macular hole

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Macular hole patients

The patients who underwent vitreous surgery for idiopathic macular hole.

Vitrectomy

Intervention Type PROCEDURE

Macular hole surgery

Interventions

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Vitrectomy

Macular hole surgery

Intervention Type PROCEDURE

Other Intervention Names

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Optical coherence tomography

Eligibility Criteria

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Inclusion Criteria

* The patients had undergone surgery from March 2008 to August 2009 at Kyorin Eye Center
* Idiopathic macular hole patients with either a Stage 2, 3, or 4 according to the Gass classification

Exclusion Criteria

* The presence of other retinal diseases including a treated rhegmatogenous retinal detachment, diabetic retinopathy
* High myopia with an axial length \> 27.0 mm or refractive error \> -8.0 diopters
* The patients followed for less than 6 months postoperatively
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

Locations

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Kyorin Eye Center

Mitaka, Tokyo, Japan

Site Status

Countries

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Japan

Other Identifiers

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Kyorineye002

Identifier Type: -

Identifier Source: org_study_id