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

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ClinicalTrials.gov Identifier: NCT02290704
Recruitment Status : Recruiting
First Posted : November 14, 2014
Last Update Posted : November 28, 2017
Sponsor:
Information provided by (Responsible Party):
Xiaonan Yang, Sun Yat-sen University

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
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.

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Study Type : Observational
Estimated 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 : January 2014
Actual Primary Completion Date : November 2017
Estimated Study Completion Date : November 2017

Resource links provided by the National Library of Medicine


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



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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Controls- normal people; GO patients- patients with Graves' ophthalmopathy
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02290704


Contacts
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Contact: Danping Huang +8613501508328 hdanp@mail.sysu.edu.cn
Contact: Xiaonan Yang +8613751859797 yangxn3@mail2.sysu.edu.cn

Locations
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China, Guangdong
Zhongshan Ophthalmic Center Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Xiaonan Yang, Master    +8613751859797    yangxn3@mail2.sysu.edu.cn   
Contact: Danping Huang, Docter    +8613501508328    hdanp@mail.sysu.edu.cn   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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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 of Results:
Other Publications:
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Responsible Party: Xiaonan Yang, the graduate student of Zhongshan Ophthalmic Center, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02290704     History of Changes
Other Study ID Numbers: 2013MEKY039
First Posted: November 14, 2014    Key Record Dates
Last Update Posted: November 28, 2017
Last Verified: November 2017

Keywords provided by Xiaonan Yang, Sun Yat-sen University:
oxygen saturation
retinal vessels
thyroid associated ophthalmopathy

Additional relevant MeSH terms:
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Eye Diseases
Graves Ophthalmopathy
Eye Diseases, Hereditary
Graves Disease
Exophthalmos
Orbital Diseases
Genetic Diseases, Inborn
Goiter
Thyroid Diseases
Endocrine System Diseases
Hyperthyroidism
Autoimmune Diseases
Immune System Diseases