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

May 9, 2016 updated by: Neon Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

102

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 73 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Macular thickness
Time Frame: one year (between Jan 2012 and Jan 2013)
Macular thickness (micrometer) was measured by optical coherence tomography in patients and controls.
one year (between Jan 2012 and Jan 2013)
Retinal nerve fiber layer thickness
Time Frame: 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.
one year (between Jan 2012 and Jan 2013)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Optic disc parameters
Time Frame: one year (between Jan 2012 and Jan 2013)
Optic disc parameters (morphologic structures) were obtained by optical coherence tomography for both groups.
one year (between Jan 2012 and Jan 2013)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neon Hospital

Collaborators

Ondokuz Mayıs University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

April 24, 2016

First Submitted That Met QC Criteria

May 9, 2016

First Posted (Estimate)

May 10, 2016

Study Record Updates

Last Update Posted (Estimate)

May 10, 2016

Last Update Submitted That Met QC Criteria

May 9, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-379

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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