Clinical trial NCT02290704: Retinal Oxygen Saturation in Patients With Graves' Ophthalmopathy and in Normal People
Official title: Changes of Retinal Oxygen Saturation in Patients With Graves' Ophthalmopathy Under Different Managing Conditions and in Normal People
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Graves' Ophthalmopathy
Keywords: oxygen saturation
retinal vessels
thyroid associated ophthalmopathy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2014-11-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Controls- normal people; GO patients- patients with Graves' ophthalmopathy

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: changes of retinal oxygen saturation in patients with GO under different managing conditions
timeFrame: before surgery ( or glucocorticoids administration), 1 week and 4 weeks after surgery ( or glucocorticoids administration)
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Danping Huang
role: STUDY_CHAIR
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Xiaonan Yang
role: STUDY_DIRECTOR
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Siming Ai
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Huasheng Yang
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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. doi: 10.1111/j.1600-0420.2005.00631.x.