Identification and Measurement of Antioxidants and Cytokines in the Anterior Chamber of Various Ocular Disorders

NCT04101591 | Unknown DMC

• 1 other identifier: 201900017B0
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Eye Diseases

Outcome Measures

Primary Outcomes (1)

• The Correlation between the Total Antioxidative Capacity (TAC) and Ascorbic Acid (Vit C)

  Most of the antioxidant capacity of aqueous humor comes from vitamin C, and there is a positive correlation between the two.

  5month

Eligibility Criteria

• Age: 1 Month - 1 Year
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Subject inclusion criteria: 1. No age limit 2. Intravitreal injection of patients (such as: diabetic retinopathy, retinal vein occlusion, age-related macular degeneration Wait) 3. 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: 1. Eyeball infection patients (such as epidemic keratoconjunctivitis, corneal ulcer, endophthalmitis, etc.) 2. Patients with uveitis (such as iridocyclitis, cytomegalovirus iriditis, toxoplasma retinal choroiditis, etc.) 3. Those with high intraocular pressure (\>40 mmHg) or too low (\<5 mmHg) 4. Those who have previously received aqueous extraction or intraocular surgery (such as cataract, vitrectomy, corneal transplantation, etc.)

You may qualify if:

• Intravitreal injection of patients
• Patients with vitreoretinal surgery
• Corneal transplant patients
• General cataract surgery patients

You may not qualify if:

• 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)

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

ChangGungMH

Taoyuan District, Taoyuan City, 333, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Separated from the systemic circulation by a blood-aqueous barrier, the aqueous humor is secreted by the ciliary process (epithelium) of the ciliary body, and fills up the anterior and posterior chambers, with a total volume of 0.15 mL \~ 0.3mL. The major constituent if water (98.7％), with minimal amount chlorides, proteins, ascorbic acid, urea, and inorganic salts. The aqueous humor presents mild alkaline with a pH value of 7.3 \~ 7.5, while its specific gravity falls between 1.002 and 1.012. The functions of aqueous humor includes 1) to preserve the shape and integrity of the globe and to maintain the intraocular pressure within normal ranges; 2) to nourish the cornea, lens, and vitreous; 3) and to provide cellular or humoral immunity in case of intraocular inflammation or infection.

MeSH Terms

Conditions

Eye Diseases

Study Officials

• Hung-Chi CHEN, PhD degree

  Chang Gung Memorial Hospital

  STUDY CHAIR

Central Study Contacts

Hung-Chi CHEN, PhD degree

CONTACT

0975365859; mr3756@cgmh.org.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2019
• First Posted: September 24, 2019
• Study Start: January 16, 2019
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: September 7, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)