Glaucoma Assessment Via Reading Ability

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Glaucoma, Primary Open Angle
• Intervention / Treatment: Diagnostic test: C-Read test

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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Chun Zhang; Phone Number: 18301031059; Email: zhangc1@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Case group; Patients with primary open angle glaucoma	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.
Control group; Healthy people	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Peking University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2023
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): February 29, 2024

Study Registration Dates

• First Submitted: December 30, 2022
• First Submitted That Met QC Criteria: December 30, 2022
• First Posted (Estimate): January 6, 2023

Study Record Updates

• Last Update Posted (Estimate): January 6, 2023
• Last Update Submitted That Met QC Criteria: December 30, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: IRB00006761-M2022800

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No