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

Not Applicable

Completed

• Conditions: Thyroid Associated Ophthalmopathy
• Interventions: Device: Optical Coherence Tomography

• Registration Number: NCT02766660
• Lead Sponsor: Neon Hospital

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.

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2016-04
• Study First Submitted: 2016-04-24
• Study First Submitted QC: 2016-05-09
• Last Update Submitted: 2016-05-09
• Study First Posted: 2016-05-10
• Last Update Posted: 2016-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Optical Coherence Tomography	Control group was consisted by age and sex- macthed healthy people adn they were measured by optical coherence tomography.
Thyroid ophthalmopathy	Optical Coherence Tomography	Thyroid associated ophthalmopathy patients were measured by optical coherence tomography.

Primary Outcome Measures

Name	Time	Method
Macular thickness	one year (between Jan 2012 and Jan 2013)	Macular thickness (micrometer) was measured by optical coherence tomography in patients and controls.
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

Name	Time	Method
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.