Glaucoma Assessment Via Reading Ability

NCT ID: NCT05673954

Last Updated: 2023-01-06

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2024-02-29

Brief 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.

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Case group

Patients with primary open angle glaucoma

C-Read test

Intervention Type: DIAGNOSTIC_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

C-Read test

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

C-Read test

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Peking University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Chun Zhang

Role: CONTACT

zhangc1@yahoo.com

18301031059

Other Identifiers

IRB00006761-M2022800

Identifier Type: -

Identifier Source: org_study_id