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

JRCT ID: jRCTs032230425

Registered date:26/10/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Healthy subjects, Glaucoma, Preperimetric glaucoma
• Date of first enrollment: 26/10/2023
• Target sample size: 39
• Study type: Interventional
• Intervention(s): Visual field testing with newly deveoped perimetry.

Outcome(s)

• Primary Outcome: Correlation analysis between conventional humphrey fielad analyzer and the newly developed perimetry.
• Secondary Outcome: Correlation analysis between optical coherence tomography and newly developed perimetry.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 80age old
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Akiba Ryutaro
• Source(s) of Monetary Support: CREWT Medical Systems, Inc.,Clinical Research Initiation-Fund (of Chiba University Hospital)