NCT05673954

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 30, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 6, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2024

Completed
Last Updated

January 6, 2023

Status Verified

December 1, 2022

Enrollment Period

12 months

First QC Date

December 30, 2022

Last Update Submit

December 30, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Case group

Patients with primary open angle glaucoma

Diagnostic Test: C-Read test

Control group

Healthy people

Diagnostic Test: C-Read test

Interventions

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.

Case groupControl group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2022

First Posted

January 6, 2023

Study Start

January 1, 2023

Primary Completion

December 31, 2023

Study Completion

February 29, 2024

Last Updated

January 6, 2023

Record last verified: 2022-12