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

Thyroid Associated Ophthalmopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02766660
• Other study ID #: 2013-379
• Status: Completed
• Phase: N/A
• First received: April 24, 2016
• Last updated: May 9, 2016
• Start date: January 2012
• Est. completion date: January 2013

Study information

• Verified date: April 2016
• Source: Neon Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 73 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Eye Diseases
• Graves Ophthalmopathy
• Thyroid Associated Ophthalmopathy
• Thyroid Diseases

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Neon Hospital	Ondokuz Mayis University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Macular thickness	Macular thickness (micrometer) was measured by optical coherence tomography in patients and controls.	one year (between Jan 2012 and Jan 2013)	No
Primary	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)	No
Secondary	Optic disc parameters	Optic disc parameters (morphologic structures) were obtained by optical coherence tomography for both groups.	one year (between Jan 2012 and Jan 2013)	No