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Clinical Trials/NCT04101591
NCT04101591
Recruiting
N/A

Species Identification and Concentration Measurement of Antioxidants and Cytokines in the Anterior Chamber From Patients of Various Ocular Disorders

Chang Gung Memorial Hospital1 site in 1 country200 target enrollmentJanuary 16, 2019
ConditionsEye Diseases

Overview

Phase
N/A
Intervention
Not specified
Conditions
Eye Diseases
Sponsor
Chang Gung Memorial Hospital
Enrollment
200
Locations
1
Primary Endpoint
The Correlation between the Total Antioxidative Capacity (TAC) and Ascorbic Acid (Vit C)
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

This study offers evaluation and treatment for patients with corneal or retinal diseases, such as corneal opacities or diabetic retinopathy. The protocol is not designed to test new treatments; rather, patients will receive current standard of care treatments. The purpose of the study is twofold: 1) to allow ophthalmologist at Chang Gung Memorial Hospital (CGMH) to increase their knowledge of altered microenvironment in the corneal or retinal disorders and identify new pathways of possible research in this area; and 2) to establish a list of patients who may be qualified for new research as they are recruited. (Participants in this protocol will not be required to join a new study; the decision is dependent on the patients themselves.) Participants will be followed at least 3 months. Follow-up visits are scheduled according to the standard of care for the individual patient's ocular problems. Visual acuity and intraocular pressure will be checked at each visit, and some of the screening tests described above may be repeated to follow the progress of disease and evaluate the response to treatment.

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."

Registry
clinicaltrials.gov
Start Date
January 16, 2019
End Date
July 31, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Chang Gung Memorial Hospital
Responsible Party
Sponsor

Eligibility Criteria

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)

Outcomes

Primary Outcomes

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.

Study Sites (1)

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