Exploratory clinical study for early detection of glaucoma using novel evaluation device.

Phase 2

Recruiting

• Conditions: Healthy subjects, Glaucoma, Preperimetric glaucoma; glaucoma, preperimetric glaucoma; D005901

• Registration Number: JPRN-jRCTs032230425
• Lead Sponsor: Akiba Ryutaro

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-10-26
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

[Healthy subject]
Subject meeting all of below conditions:
1. Age between 20 and 80 years.
2. Eyes with open angle
3. Eyes with best corrected decimal visual acuity of or above 0.5
4. Eyes with refractive error of less than -6 diopters (spherical) and -3 diopters (cylinder).
5. Subject must undergo through explanation of the study, then sign the written consent form upon subject's free will.
6. Eyes without diagnosis of glaucoma or preperimetric glaucoma.

[Glaucoma subject]
Must meet criteria 1-5 of healthy subjects, and have eyes diagnosed as glaucoma.

[Preprimetric glaucoma subject]
Must meet criteria 1-5 of healyh subjects, and have eyesdiagnosed as preperimetric glaucoma.

Exclusion Criteria

1. Subject regarded as non-qualified by doctor in chief of the clinical study.
2. Eyes with history of ocular trauma, or intraocular surgery (Except for cataract and glaucoma with no surgical complications.)
3. Eyes with underlying retinal disease, uveitis, and non-glaucomatous optic neuritis.
4. History of optic chiasm disaese or demyelinating disease that affect visual field.
5. History of cognitive disase including Parkinson's diesase, Alzheimer's disease, and cerebral infarction.
6. Eyes with poor fixation upon Humphrey visual field test.

Study & Design

• Study Type: Interventional
• Study Design: Not specified