NCT03270761

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 1, 2017

Completed
9 days until next milestone

Study Start

First participant enrolled

September 10, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2019

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

June 8, 2021

Status Verified

June 1, 2021

Enrollment Period

2.3 years

First QC Date

August 24, 2017

Last Update Submit

June 6, 2021

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

  • Management in patients with Iridocorneal endothelial (ICE) syndrome

    Record the number of medication treating corneal edema or glaucoma, and surgery (anti-glaucoma surgery, keratoplasty)

    through study completion, an average of 1 year

Secondary Outcomes (1)

  • Demographic profile of patients

    1 day

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

ICE syndrome patients identified and enrolled from 50 study centers in China.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, 510060, China

Location

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.

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Xiulan Zhang, MD,PhD

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD,PhD

Study Record Dates

First Submitted

August 24, 2017

First Posted

September 1, 2017

Study Start

September 10, 2017

Primary Completion

December 12, 2019

Study Completion

December 31, 2019

Last Updated

June 8, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)