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Completed

NCT Number: NCT02766660

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

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.

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Key information

Conditions

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

Age range

12 year–73 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

optical coherence tomography

Device

All groups were measured by optical coherence tomography.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Neon Hospital

Other

Collaborators

  • Ondokuz Mayıs University

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 10, 2016
Registry last updated
May 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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