Optic Disc, Macula, and Retinal Nerve Fiber Layer Measurements Obtained by OCT in Thyroid Associated Ophthalmopathy

NCT ID: NCT02766660

Last Updated: 2016-05-10

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

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-01-31

Brief Summary

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The aim of the study is to compare the measurements of retinal nerve fiber layer (RNFL), macula and optical disc parameters obtained by optical coherence tomography (OCT), and intraocular pressure (IOP) between the patients with thyroid-associated ophthalmopathy (TAO) and healthy controls.

Detailed Description

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One hundred and thirty two eyes of 66 patients with TAO and 72 eyes of 36 healthy controls were included in the study. Proptosis level was determined by Hertel exophthalmometer. Optic disc, peripapillary retinal nerve fiber layer and macula parameters were measured by OCT. All measurements were compared between the patients and age and sex-matched healthy controls.

Conditions

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Thyroid Associated Ophthalmopathy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Thyroid ophthalmopathy

Thyroid associated ophthalmopathy patients were measured by optical coherence tomography.

Group Type OTHER

Optical Coherence Tomography

Intervention Type DEVICE

All groups were measured by optical coherence tomography.

Control

Control group was consisted by age and sex- macthed healthy people adn they were measured by optical coherence tomography.

Group Type OTHER

Optical Coherence Tomography

Intervention Type DEVICE

All groups were measured by optical coherence tomography.

Interventions

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Optical Coherence Tomography

All groups were measured by optical coherence tomography.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

The control group was chosen among healthy volunteers who have

* no eye pathology,
* 20/20 vision (corrected or uncorrected),
* age and sex-matched with the patient group.

Exclusion Criteria

For both groups, those who had

* significant sight impairment,
* high myopia ( \< -5Diopters ),
* high hyperopia ( \> +3Diopters ),
* optic disc anomaly,
* vitreoretinal interface disease,
* vascular and degenerative retinal diseases,
* cornea or lens opacity, ocular surgery history,
* glaucoma,
* neurological diseases that can affect the visual field,
* history of trauma, amblyopia,
* diplopia,
* keratitis,
* history of topical or systemic steroid
Minimum Eligible Age

12 Years

Maximum Eligible Age

73 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ondokuz Mayıs University

OTHER

Sponsor Role collaborator

Neon Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nurşen ARITÜRK, Prof.

Role: PRINCIPAL_INVESTIGATOR

Ondokuz Mayıs University

References

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Sayin O, Yeter V, Ariturk N. Optic Disc, Macula, and Retinal Nerve Fiber Layer Measurements Obtained by OCT in Thyroid-Associated Ophthalmopathy. J Ophthalmol. 2016;2016:9452687. doi: 10.1155/2016/9452687. Epub 2016 Jul 17.

Reference Type DERIVED
PMID: 27493796 (View on PubMed)

Other Identifiers

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2013-379

Identifier Type: -

Identifier Source: org_study_id

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