- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04101591
Identification and Measurement of Antioxidants and Cytokines in the Anterior Chamber of Various Ocular Disorders
Species Identification and Concentration Measurement of Antioxidants and Cytokines in the Anterior Chamber From Patients of Various Ocular Disorders
Study Overview
Status
Conditions
Detailed Description
The primary purpose of the protocol is to accumulate a cohort of patients with corneal or retinal diseases for possible participation in new CGMH clinical trials and epidemiological protocols. Also, by providing long-term follow-up and treatment for a variety of corneal or retinal disorders, the relevant specialists and basic scientists at CGMH will be better able to identify research hypotheses about these diseases in addition to maintaining their clinical skills. The availability of cohorts of patients with a spectrum of corneal or retinal disorders will be valuable for the training of fellows in external eye or intraocular diseases, an important mission of the CGMH. The ability to provide long-term follow-up and care will also facilitate referral efforts for new CGMH protocols.
The corneal or retinal specialists at the Chang Gung Memorial Hospital will be free to choose those ocular disorders that interest them. However, the total number of patients that can be enrolled in the protocol will be restricted. This protocol is not designed to test any new treatments. Any evaluations or treatment under this protocol will be based on the current standard of care for each corneal or retinal diseases.
Participants in this patient evaluation and treatment protocol will be evaluated for potential eligibility in any new CGMH clinical trials or epidemiologic protocols as they are developed. If eligible, patients may be asked to participate in the new protocol. However, they will not be required to enter any protocol and their decision to participate will be entirely voluntary. No more than 200 patients will be accepted in this "Evaluation and Treatment Protocol."
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Hung-Chi CHEN, PhD degree
- Phone Number: 0975365859
- Email: mr3756@cgmh.org.tw
Study Locations
-
-
Taoyuan City
-
Taoyuan, Taoyuan City, Taiwan, 333
- Recruiting
- ChangGungMH
-
Contact:
- Hung-Chi CHEN, PhD degree
- Phone Number: 0975365859
- Email: mr3756@cgmh.org.tw
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Subject inclusion criteria:
- No age limit
- Intravitreal injection of patients (such as: diabetic retinopathy, retinal vein occlusion, age-related macular degeneration Wait)
- Patients with vitreoretinal surgery (such as retinal detachment, macular wrinkles, macular holes, etc.), 4 corneal transplant patients (such as keratoconus, corneal opacity, corneal endothelial dystrophy, etc.)
5. General cataract surgery patients
Subject exclusion criteria:
- Eyeball infection patients (such as epidemic keratoconjunctivitis, corneal ulcer, endophthalmitis, etc.)
- Patients with uveitis (such as iridocyclitis, cytomegalovirus iriditis, toxoplasma retinal choroiditis, etc.)
- Those with high intraocular pressure (>40 mmHg) or too low (<5 mmHg)
- Those who have previously received aqueous extraction or intraocular surgery (such as cataract, vitrectomy, corneal transplantation, etc.)
Description
Inclusion Criteria:
- Intravitreal injection of patients
- Patients with vitreoretinal surgery
- Corneal transplant patients
- General cataract surgery patients
Exclusion Criteria:
- Those who have previously received aqueous extraction or intraocular surgery
- Eyeball infection patients
- Patients with uveitis
- Those with high intraocular pressure (>40 mmHg) or too low (<5 mmHg)
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Correlation between the Total Antioxidative Capacity (TAC) and Ascorbic Acid (Vit C)
Time Frame: 5month
|
Most of the antioxidant capacity of aqueous humor comes from vitamin C, and there is a positive correlation between the two.
|
5month
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Hung-Chi CHEN, PhD degree, Chang Gung Memorial Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201900017B0
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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