Glaucoma Assessment Via Reading Ability

Sponsor
Peking University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05673954
Collaborator
(none)
200
13.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Glaucoma Assessment Via Reading Ability Using Logarithmic Chinese Reading Acuity Chart
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Feb 29, 2024

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. The Relationship between Reading Ability and C-READ Test Results [January 2023 to December 2023]

    The Relationship between Reading Ability and C-READ Test Results

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Peking University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Peking University
ClinicalTrials.gov Identifier:
NCT05673954
Other Study ID Numbers:
  • IRB00006761-M2022800
First Posted:
Jan 6, 2023
Last Update Posted:
Jan 6, 2023
Last Verified:
Dec 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 6, 2023