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

NCT02766660 | Completed

• 1 other identifier: 2013-379
• Study Type: interventional
• Target: 102
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Thyroid Associated Ophthalmopathy

Keywords

Thyroid ophthalmopathy; optical coherence tomography

Outcome Measures

Primary Outcomes (2)

• Macular thickness

  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

  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 Outcomes (1)

• Optic disc parameters

  one year (between Jan 2012 and Jan 2013)

Study Arms (2)

Thyroid ophthalmopathy

OTHER

Thyroid associated ophthalmopathy patients were measured by optical coherence tomography.

Device: Optical Coherence Tomography

Control

OTHER

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

Device: Optical Coherence Tomography

Interventions

Optical Coherence Tomography DEVICE

All groups were measured by optical coherence tomography.

Control; Thyroid ophthalmopathy

Eligibility Criteria

• Age: 12 Years - 73 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The control group was chosen among healthy volunteers who have
• no eye pathology,
• /20 vision (corrected or uncorrected),
• age and sex-matched with the patient group.

You may not qualify if:

• 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

Sponsors & Collaborators

• Neon Hospital: lead
• Ondokuz Mayıs University: collaborator

Related Publications (1)

• 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.

  PMID: 27493796 DERIVED

MeSH Terms

Conditions

Graves Ophthalmopathy

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Graves Disease; Exophthalmos; Orbital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Officials

• Nurşen ARITÜRK, Prof.

  Ondokuz Mayıs University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2016
• First Posted: May 10, 2016
• Study Start: January 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: May 10, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share