Retinal Oxygen Saturation in Patients With Graves' Ophthalmopathy and in Normal People

Changes of Retinal Oxygen Saturation in Patients With Graves' Ophthalmopathy Under Different Managing Conditions and in Normal People

Find if the retinal function is affected in both the nonsevere and the severe stage of Graves' ophthalmopathy (GO) by comparing the retinal oxygen saturation of GO patients with that of normal people.

Study Overview

• Status: Unknown
• Conditions: Graves' Ophthalmopathy

Detailed Description

Graves'ophthalmopathy (GO), also called thyroid-associated ophthalmopathy, is often mild and self-limiting, and probably declining in frequency, with only 3-5% of cases posing a threat to eyesight, remaining a pathogenetic enigma and a therapeutic dilemma. In its nonsevere expression, the symptoms and signs include Photophobia, Foreign body sensation, Eyelid retraction, increased intraocular pressure, Lagophthalmos, and Mild diplopia. In its severe expression, it is a disfiguring and invalidating disease with the optic nerve damaged. However, in this study, we want to find if the retinal vessels is affected in the early stage of the disease through observing the oxygen saturation of the retinal vessels and compare it with that of the normal people.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Danping Huang; Phone Number: +8613501508328; Email: hdanp@mail.sysu.edu.cn
• Study Contact Backup: Name: Xiaonan Yang; Phone Number: +8613751859797; Email: yangxn3@mail2.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • Zhongshan Ophthalmic Center
      • Contact: Xiaonan Yang, Master; Phone Number: +8613751859797; Email: yangxn3@mail2.sysu.edu.cn
      • Contact: Danping Huang, Docter; Phone Number: +8613501508328; Email: hdanp@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Controls- normal people; GO patients- patients with Graves' ophthalmopathy

Description

Inclusion Criteria for GO patients:

1. conforms to the diagnosis of Graves' ophthalmopathy;
2. age > 18;
3. volunteered to participate in this research, and sign the informed consent.

Inclusion Criteria for Control group:

1. age > 18;
2. diopter within + / - 3D;
3. volunteered to participate in this research, and sign the informed consent.

Exclusion Criteria for GO patients:

1. Fundus could not be seen clearly;
2. pregnant and lactating women;
3. could not tolerate the examination.

Exclusion Criteria for Control group:

1. with severe systemic disease and cause eye lesions;
2. have history of eye disease, ocular trauma and eye surgery impacting on visual function;
3. pregnant and lactating women;
4. could not tolerate the examination.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
controls; People without eye disease
GO patients; patients with Graves' ophthalmopathy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
changes of retinal oxygen saturation in patients with GO under different managing conditions	before surgery ( or glucocorticoids administration), 1 week and 4 weeks after surgery ( or glucocorticoids administration)

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Investigators: Study Chair: Danping Huang, Zhongshan Ophthalmic Center, Sun Yat-sen University; Study Director: Xiaonan Yang, Zhongshan Ophthalmic Center, Sun Yat-sen University; Principal Investigator: Siming Ai, Zhongshan Ophthalmic Center, Sun Yat-sen University; Principal Investigator: Huasheng Yang, Zhongshan Ophthalmic Center, Sun Yat-sen University

Publications and helpful links

General Publications

• Bahn RS, Heufelder AE. Pathogenesis of Graves' ophthalmopathy. N Engl J Med. 1993 Nov 11;329(20):1468-75. doi: 10.1056/NEJM199311113292007. No abstract available.
• Alford EL, Soparkar CN. Management of the 'tight orbit' and associated visual loss. Curr Opin Otolaryngol Head Neck Surg. 2013 Aug;21(4):417-22. doi: 10.1097/MOO.0b013e32836312a1.
• Michelson G, Scibor M. Intravascular oxygen saturation in retinal vessels in normal subjects and open-angle glaucoma subjects. Acta Ophthalmol Scand. 2006 Jun;84(3):289-95. doi: 10.1111/j.1600-0420.2005.00631.x.

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): November 1, 2017
• Study Completion (Anticipated): November 1, 2017

Study Registration Dates

• First Submitted: November 3, 2014
• First Submitted That Met QC Criteria: November 13, 2014
• First Posted (Estimate): November 14, 2014

Study Record Updates

• Last Update Posted (Actual): November 28, 2017
• Last Update Submitted That Met QC Criteria: November 25, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: retinal vessels; oxygen saturation; thyroid associated ophthalmopathy
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Genetic Diseases, Inborn; Thyroid Diseases; Eye Diseases, Hereditary; Graves Disease; Exophthalmos; Orbital Diseases; Goiter; Hyperthyroidism; Eye Diseases; Graves Ophthalmopathy
• Other Study ID Numbers: 2013MEKY039