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

Sponsor

Sun Yat-sen University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02290704

Collaborator

(none)

200

Enrollment

Location

Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
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 Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jan 1, 2014

Actual Primary Completion Date :

Nov 1, 2017

Anticipated Study Completion Date :

Nov 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
controls People without eye disease
GO patients patients with Graves' ophthalmopathy

Outcome Measures

Primary Outcome Measures

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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria for GO patients:

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

Inclusion Criteria for Control group:

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

Exclusion Criteria for GO patients:

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

Exclusion Criteria for Control group:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhongshan Ophthalmic Center	Guangzhou	Guangdong	China	510000

Sponsors and Collaborators

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