Eye DiseasesNCT04101591
Identification and Measurement of Antioxidants and Cytokines in the Anterior Chamber of Various Ocular Disorders
An observational study of Eye Diseases, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 1 yearHealthy volunteers can take part
- Conditions the study is for
- Eye Diseases
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 16 Jan 2019to 31 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 1 year
- All sexes
- Healthy volunteers accepted
- Child
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.)
Who may be able to join
- Intravitreal injection of patients
- Patients with vitreoretinal surgery
- Corneal transplant patients
- General cataract surgery patients
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
ChangGungMH
Taoyuan, Taoyuan City, 333
Hung-Chi CHEN, PhD degree, 0975365859, mr3756@cgmh.org.tw
About this study
Official title: Species Identification and Concentration Measurement of Antioxidants and Cytokines in the Anterior Chamber From Patients of Various Ocular Disorders
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.
Read the 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."
- Conditions
- Eye Diseases
- Medical subject headings
- Eye Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study start16 Jan 2019
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye DiseasesStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hung-Chi CHEN, PhD degree, Study chair, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04101591
- Sponsor's protocol ID
- 201900017B0
- Status last verified
- Sep 2023
- First submitted
- 22 Sep 2019
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Species Identification and Concentration Measurement of Antioxidants and Cytokines in the Anterior Chamber From Patients of Various Ocular Disorders
- ClinicalTrials.gov ID
- NCT04101591
- Acronym / sponsor ID
- 201900017B0
- Conditions
- Eye Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 16 Jan 2019 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 24 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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."
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 1 year
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.)
Key inclusion criteria (4 listed)
- Intravitreal injection of patients
- Patients with vitreoretinal surgery
- Corneal transplant patients
- General cataract surgery patients
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hung-Chi CHEN, PhD degree study chair
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eye Diseases, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hung-Chi CHEN, PhD degree (0975365859, mr3756@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Correlation between the Total Antioxidative Capacity (TAC) and Ascorbic Acid (Vit C) (time frame: 5month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023.