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

NCT02290704 | Unknown DMC

• 1 other identifier: 2013MEKY039
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Graves' Ophthalmopathy

Keywords

oxygen saturation; retinal vessels; thyroid associated ophthalmopathy

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

controls

People without eye disease

GO patients

patients with Graves' ophthalmopathy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• conforms to the diagnosis of Graves' ophthalmopathy;
• age \> 18;
• volunteered to participate in this research, and sign the informed consent.
• age \> 18;
• diopter within + / - 3D;
• volunteered to participate in this research, and sign the informed consent.

You may not qualify if:

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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, 510000, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 8413459 BACKGROUND

• 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.

  PMID: 23838551 BACKGROUND

• 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.

  PMID: 16704685 RESULT

MeSH Terms

Conditions

Graves Ophthalmopathy

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Graves Disease; Exophthalmos; Orbital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Study Officials

• Danping Huang

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  STUDY CHAIR

• Xiaonan Yang

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  STUDY DIRECTOR

• Siming Ai

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

• Huasheng Yang

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Danping Huang

CONTACT

+8613501508328; hdanp@mail.sysu.edu.cn

Xiaonan Yang

CONTACT

+8613751859797; yangxn3@mail2.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: the graduate student of Zhongshan Ophthalmic Center

Study Record Dates

• First Submitted: November 3, 2014
• First Posted: November 14, 2014
• Study Start: January 1, 2014
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: November 28, 2017

Record last verified: 2017-11

Locations

CN (1)