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

Sponsor
Neon Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02766660
Collaborator
Ondokuz Mayıs University (Other)
102
Enrollment
2
Arms
12
Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Optical Coherence Tomography
 N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
102 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Optic Disc, Macula, and Retinal Nerve Fiber Layer Measurements Obtained by OCT in Thyroid Associated Ophthalmopathy
Study Start Date :
Jan 1, 2012
Actual Primary Completion Date :
Jan 1, 2013
Actual Study Completion Date :
Jan 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Other: Thyroid ophthalmopathy

Thyroid associated ophthalmopathy patients were measured by optical coherence tomography.

Device: Optical Coherence Tomography
All groups were measured by optical coherence tomography.
Other: Control

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

Device: Optical Coherence Tomography
All groups were measured by optical coherence tomography.

Outcome Measures

Primary Outcome Measures

  1. Macular thickness [one year (between Jan 2012 and Jan 2013)]

    Macular thickness (micrometer) was measured by optical coherence tomography in patients and controls.

  2. Retinal nerve fiber layer thickness [one year (between Jan 2012 and Jan 2013)]

    Retinal nerve fiber layer thickness (micrometer) was measured by optical coherence tomography in patient and control groups.

Secondary Outcome Measures

  1. Optic disc parameters [one year (between Jan 2012 and Jan 2013)]

    Optic disc parameters (morphologic structures) were obtained by optical coherence tomography for both groups.

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years to 73 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

Inclusion Criteria: Patient group consists the consecutive patients with thyroid associated ophthalmopathy consulted by endocrinology department.

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Neon Hospital
  • Ondokuz Mayıs University

Investigators

  • Principal Investigator: Nurşen ARITÜRK, Prof., Ondokuz Mayıs University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Neon Hospital
ClinicalTrials.gov Identifier:
NCT02766660
Other Study ID Numbers:
  • 2013-379
First Posted:
May 10, 2016
Last Update Posted:
May 10, 2016
Last Verified:
Apr 1, 2016
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Neon Hospital
Thyroid ophthalmopathy
optical coherence tomography
Additional relevant MeSH terms:
Eye Diseases
Graves Ophthalmopathy
Thyroid Diseases

Study Results

No Results Posted as of May 10, 2016