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

Primary Purpose

Thyroid Associated Ophthalmopathy

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Optical Coherence Tomography
Sponsored by
Neon Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Thyroid Associated Ophthalmopathy focused on measuring Thyroid ophthalmopathy, optical coherence tomography

Eligibility Criteria

12 Years - 73 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Thyroid ophthalmopathy

    Control

    Arm Description

    Thyroid associated ophthalmopathy patients were measured by optical coherence tomography.

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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    April 24, 2016
    Last Updated
    May 9, 2016
    Sponsor
    Neon Hospital
    Collaborators
    Ondokuz Mayıs University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02766660
    Brief Title
    Optic Disc, Macula, and Retinal Nerve Fiber Layer Measurements Obtained by OCT in Thyroid Associated Ophthalmopathy
    Official Title
    Optic Disc, Macula, and Retinal Nerve Fiber Layer Measurements Obtained by OCT in Thyroid Associated Ophthalmopathy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2012 (undefined)
    Primary Completion Date
    January 2013 (Actual)
    Study Completion Date
    January 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Neon Hospital
    Collaborators
    Ondokuz Mayıs University

    4. Oversight

    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Thyroid Associated Ophthalmopathy
    Keywords
    Thyroid ophthalmopathy, optical coherence tomography

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    102 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Thyroid ophthalmopathy
    Arm Type
    Other
    Arm Description
    Thyroid associated ophthalmopathy patients were measured by optical coherence tomography.
    Arm Title
    Control
    Arm Type
    Other
    Arm Description
    Control group was consisted by age and sex- macthed healthy people adn they were measured by optical coherence tomography.
    Intervention Type
    Device
    Intervention Name(s)
    Optical Coherence Tomography
    Intervention Description
    All groups were measured by optical coherence tomography.
    Primary Outcome Measure Information:
    Title
    Macular thickness
    Description
    Macular thickness (micrometer) was measured by optical coherence tomography in patients and controls.
    Time Frame
    one year (between Jan 2012 and Jan 2013)
    Title
    Retinal nerve fiber layer thickness
    Description
    Retinal nerve fiber layer thickness (micrometer) was measured by optical coherence tomography in patient and control groups.
    Time Frame
    one year (between Jan 2012 and Jan 2013)
    Secondary Outcome Measure Information:
    Title
    Optic disc parameters
    Description
    Optic disc parameters (morphologic structures) were obtained by optical coherence tomography for both groups.
    Time Frame
    one year (between Jan 2012 and Jan 2013)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Maximum Age & Unit of Time
    73 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nurşen ARITÜRK, Prof.
    Organizational Affiliation
    Ondokuz Mayıs University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    27493796
    Citation
    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.
    Results Reference
    derived

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

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