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

Graves' Ophthalmopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02290704
• Other study ID #: 2013MEKY039
• Status: Recruiting
• Phase: N/A
• First received: November 3, 2014
• Last updated: November 25, 2017
• Start date: January 2014
• Est. completion date: November 2017

Study information

• Verified date: November 2017
• Source: Sun Yat-sen University
• Contact: Danping Huang
• Phone: +8613501508328
• Email: hdanp[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Eye Diseases
• Graves Ophthalmopathy
• Graves' Ophthalmopathy

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (3)

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. Review. — View Citation

Bahn RS, Heufelder AE. Pathogenesis of Graves' ophthalmopathy. N Engl J Med. 1993 Nov 11;329(20):1468-75. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)