MedDataX Logo

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

NCT ID: NCT02290704

Last Updated: 2017-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2017-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Graves' Ophthalmopathy

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

oxygen saturation retinal vessels thyroid associated ophthalmopathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

controls

People without eye disease

No interventions assigned to this group

GO patients

patients with Graves' ophthalmopathy

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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


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

Exclusion Criteria

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


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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Xiaonan Yang

the graduate student of Zhongshan Ophthalmic Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Danping Huang

Role: STUDY_CHAIR

Zhongshan Ophthalmic Center, Sun Yat-sen University

Xiaonan Yang

Role: STUDY_DIRECTOR

Zhongshan Ophthalmic Center, Sun Yat-sen University

Siming Ai

Role: PRINCIPAL_INVESTIGATOR

Zhongshan Ophthalmic Center, Sun Yat-sen University

Huasheng Yang

Role: PRINCIPAL_INVESTIGATOR

Zhongshan Ophthalmic Center, Sun Yat-sen University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Danping Huang

Role: CONTACT

Phone: +8613501508328

Email: [email protected]

Xiaonan Yang

Role: CONTACT

Phone: +8613751859797

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Xiaonan Yang, Master

Role: primary

Danping Huang, Docter

Role: backup

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 8413459 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23838551 (View on PubMed)

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.

Reference Type RESULT
PMID: 16704685 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2013MEKY039

Identifier Type: -

Identifier Source: org_study_id