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Zhongshan Iridocorneal Endothelial Syndrome Study (ICEs)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03270761
Recruitment Status : Recruiting
First Posted : September 1, 2017
Last Update Posted : April 16, 2019
Sponsor:
Collaborator:
ICE study group
Information provided by (Responsible Party):
Xiulan Zhang, Sun Yat-sen University

Brief Summary:
This is a multi-center study to report the demographic profile, clinical features, and management in patients with Iridocorneal endothelial (ICE) syndrome in China.

Condition or disease
Glaucoma

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Day
Official Title: A Multi-center Study on Iridocorneal Endothelial (ICE) Syndrome in China
Actual Study Start Date : September 10, 2017
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : December 31, 2019





Primary Outcome Measures :
  1. Management in patients with Iridocorneal endothelial (ICE) syndrome [ Time Frame: through study completion, an average of 1 year ]
    Record the number of medication treating corneal edema or glaucoma, and surgery (anti-glaucoma surgery, keratoplasty)


Secondary Outcome Measures :
  1. Demographic profile of patients [ Time Frame: 1 day ]
    Range of age, gender


Biospecimen Retention:   Samples With DNA
12ml Blood will be collected. Aqueous humor,iris,or excised corneal will be gathered if trabeculectomy,drainage shunt valve implantation, or penetrating keratoplasty needed.


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
ICE syndrome patients identified and enrolled from 50 study centers in China.
Criteria

Inclusion Criteria:

  • Clinical diagnosis of ICE syndrome;
  • Those willing to sign the informed consent.

Exclusion Criteria:

  • Patients who don't sign the informed consent or abide by the study procedure.

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): NCT03270761


Contacts
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Contact: Xiulan Zhang, MD,PhD 020-87332702 zhangxl2@mail.sysu.edu.cn <zhangxl2@mail.sysu.edu.cn>

Locations
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China, Guangdong
Zhongshan Ophthalmic Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Xiulan Zhang, MD,PhD    020-87332702    zhangxl2@mail.sysu.edu.cn   
Principal Investigator: Xiulan Zhang, MD,PhD         
Sponsors and Collaborators
Sun Yat-sen University
ICE study group
Investigators
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Principal Investigator: Xiulan Zhang, MD,PhD Zhongshan Ophthalmic Center, Sun Yat-sen University
Additional Information:

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Responsible Party: Xiulan Zhang, MD,PhD, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03270761    
Other Study ID Numbers: 2017KYPJ071
First Posted: September 1, 2017    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Eye Diseases