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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05673954
Other study ID # IRB00006761-M2022800
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 1, 2023
Est. completion date February 29, 2024

Study information

Verified date December 2022
Source Peking University
Contact Chun Zhang
Phone 18301031059
Email zhangc1@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 200
Est. completion date February 29, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Intervention

Diagnostic Test:
C-Read test
C-Read is a reliable and valid clinical tool for quantitatively testing the reading ability of readers of simplified Chinese characters.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Peking University

Outcome

Type Measure Description Time frame Safety issue
Primary The Relationship between Reading Ability and C-READ Test Results The Relationship between Reading Ability and C-READ Test Results January 2023 to December 2023
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