Glaucoma, Primary Open AngleNCT05673954
Glaucoma Assessment Via Reading Ability
An observational study of Glaucoma, Primary Open Angle, run by Peking University.
Trial summary
To explore a quantitative glaucoma evaluation tool of glaucoma through the dynamic evaluation of reading ability based on logarithmic Chinese reading acuity chart (C-READ), and investigate its feasibility. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma, Primary Open Angle
- What is being tested?
- C-Read test
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2023to 29 Feb 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The patients who were diagnosed as primary open angle glaucoma in the Eye Center of the Third Hospital of Beijing Medical University from January 2023 to December 2023 will be included. At the same time, healthy people will be included as the control group.
Who may be able to join
- Primary open angle glaucoma in at least 1 eye or labelled as a glaucoma suspect by a glaucoma specialist
- Age ≥18 years old
- with open angles on gonioscopy
- best-corrected visual acuity ≥0.5
- spherical refraction within ±5.0 diopters (D), and/or cylinder correction within 3.0 D
Who cannot join
- eyes with any evidence of physical abnormality of the iris or pupils on slit-lamp examination
- eyes with a history of trauma or inflammation
- undergone an intraocular surgery or laser within the previous 6 months/except uncomplicated cataract surgery
- using systemic or topical medications that could affect pupil responses, including pilocarpine or atropine
- presence of any media opacities that prevented good quality OCT or fundus images
- presence of any retinal or neurological disease other than glaucoma
- abnormal ocular motility that prevents binocular fixation (eg, nystagmus, strabismus)
- with severe systemic diseases or psychiatric disorders
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Glaucoma Assessment Via Reading Ability Using Logarithmic Chinese Reading Acuity Chart
To explore a quantitative glaucoma evaluation tool of glaucoma through the dynamic evaluation of reading ability based on logarithmic Chinese reading acuity chart (C-READ), and investigate its feasibility.
Read the detailed description
Glaucoma is the most common cause of irreversible blindness in the world, and it's marked by the gradual loss of retinal ganglion cells and their optic nerve fibres. Early detection and treatment can successfully prevent the disease's development and prevent blindness. Glaucoma sufferers' near visual qualities, particularly their ability to read, might be compromised. Patients can, however, regain some comfortable reading capacity following glaucoma therapy. The logarithmic Chinese reading acuity chart (C-READ) can be beneficial as a tool for functional vision evaluation, and there is rising clinical interest in this well-standardized, calibrated reading chart. Reading chart standards that allow for equal assessment of reading factors such as acuity and speed are currently lacking. The C-READ approach as a judge of glaucoma patients' status lacks theoretical support, and functional visual evaluation tools are still in their infancy. Therefore, we want to complete these tasks: 1) develop a dynamic analytic system and improve the evaluation criteria for the C-READ testing procedure; 2) confirm the usefulness of C-READ for early glaucoma screening through clinical studies. C-READ will provide a reliable and cost-effective screening technique that is convenient, affordable, and noninvasive.
- Conditions
- Glaucoma, Primary Open Angle
- Being tested
- C-Read test
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-Read testDiagnostic test
C-Read is a reliable and valid clinical tool for quantitatively testing the reading ability of readers of simplified Chinese characters.
| Study group | Role | What they receive |
|---|---|---|
| Case group | Patients with primary open angle glaucoma Receives: Diagnostic Test: C-Read test | |
| Control group | Healthy people Receives: Diagnostic Test: C-Read test |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Relationship between Reading Ability and C-READ Test Results
The Relationship between Reading Ability and C-READ Test Results
Measured: January 2023 to December 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start1 Jan 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion29 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, Primary Open AngleStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05673954
- Sponsor's protocol ID
- IRB00006761-M2022800
- Status last verified
- Dec 2022
- First submitted
- 30 Dec 2022
- Last updated
- 6 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glaucoma Assessment Via Reading Ability Using Logarithmic Chinese Reading Acuity Chart
- ClinicalTrials.gov ID
- NCT05673954
- Acronym / sponsor ID
- IRB00006761-M2022800
- Conditions
- Glaucoma, Primary Open Angle
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 29 Feb 2024 (estimated)
- First posted
- 6 Jan 2023 (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.
To explore a quantitative glaucoma evaluation tool of glaucoma through the dynamic evaluation of reading ability based on logarithmic Chinese reading acuity chart (C-READ), and investigate its feasibility.
Detailed description
Glaucoma is the most common cause of irreversible blindness in the world, and it's marked by the gradual loss of retinal ganglion cells and their optic nerve fibres. Early detection and treatment can successfully prevent the disease's development and prevent blindness. Glaucoma sufferers' near visual qualities, particularly their ability to read, might be compromised. Patients can, however, regain some comfortable reading capacity following glaucoma therapy. The logarithmic Chinese reading acuity chart (C-READ) can be beneficial as a tool for functional vision evaluation, and there is rising clinical interest in this well-standardized, calibrated reading chart. Reading chart standards that allow for equal assessment of reading factors such as acuity and speed are currently lacking. The C-READ approach as a judge of glaucoma patients' status lacks theoretical support, and functional visual evaluation tools are still in their infancy. Therefore, we want to complete these tasks: 1) develop a dynamic analytic system and improve the evaluation criteria for the C-READ testing procedure; 2) confirm the usefulness of C-READ for early glaucoma screening through clinical studies. C-READ will provide a reliable and cost-effective screening technique that is convenient, affordable, and noninvasive.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group | – | Diagnostic Test: C-Read testPatients with primary open angle glaucoma |
| Control group | – | Diagnostic Test: C-Read testHealthy people |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The patients who were diagnosed as primary open angle glaucoma in the Eye Center of the Third Hospital of Beijing Medical University from January 2023 to December 2023 will be included. At the same time, healthy people will be included as the control group.
Key inclusion criteria (5 listed)
- Primary open angle glaucoma in at least 1 eye or labelled as a glaucoma suspect by a glaucoma specialist
- Age ≥18 years old
- with open angles on gonioscopy
- best-corrected visual acuity ≥0.5
- spherical refraction within ±5.0 diopters (D), and/or cylinder correction within 3.0 D
Key exclusion criteria (8 listed)
- eyes with any evidence of physical abnormality of the iris or pupils on slit-lamp examination
- eyes with a history of trauma or inflammation
- undergone an intraocular surgery or laser within the previous 6 months/except uncomplicated cataract surgery
- using systemic or topical medications that could affect pupil responses, including pilocarpine or atropine
- presence of any media opacities that prevented good quality OCT or fundus images
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C-Read testC-Read is a reliable and valid clinical tool for quantitatively testing the reading ability of readers of simplified Chinese characters. | Diagnostic test | Case group, Control group |
Primary outcome
The Relationship between Reading Ability and C-READ Test Results
Time frame: January 2023 to December 2023
The Relationship between Reading Ability and C-READ Test Results
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2023.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma, Primary Open Angle, run by Peking University.
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 5 inclusion and 8 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 6 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Chun Zhang (18301031059, zhangc1@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Relationship between Reading Ability and C-READ Test Results (time frame: January 2023 to December 2023). 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 6 Jan 2023.