Glaucoma HFA / OCT Specificity Study

Study Overview
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Brief Summary
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Study consists of five visits over a one to three month time period.

Detailed Description
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Each visit consists of optical coherence tomography (OCT) scanning (4 scans ) and two HFA (Humphrey Field Analyzer) visual fields of the study eye only.

Official Title
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Glaucoma HFA / OCT Specificity Study

Conditions
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Glaucoma

Intervention / Treatment
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* Device: OCT scanning and HFA perimetry


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult males or females 40 to 80 years old Able and willing to attend the required study visits Able and willing to provide consent and follow study instructions in English A diagnosis by the Principal Investigator or co-investigator of glaucoma, pre-perimetric glaucoma or glaucoma suspect Subjects must have experience in threshold automated perimetry, having performed a previous SITA (Swedish Interactive Thresholding Algorithm) threshold test within one year of enrolling to the study Ability to fixate that allows obtaining acceptable visual fields and OCT scans in the study eye Exclusion Criteria: • Best-corrected visual acuity less than 20/40 (study eye only) on a Snellen chart or on a Snellen equivalent acuity chart Spherical refraction outside -12.00 to +5.00 diopters (D) or cylinder correction outside 3.00 D (study eye only) Amblyopia (either eye) Narrow irido-corneal angles or a diagnosis of narrow angle glaucoma Previous or current eye disease in the study eye, serious eye trauma or intraocular surgery (except cataracts with lens implants), or the presence of ocular findings that could affect the visual field, other than glaucoma Cataract surgery in the study eye within six (6) months of first visit Dx of any optic neuropathy other than glaucoma Vitreoretinal traction or epiretinal membrane in the study eye Diagnosis or history of any systemic disease / condition / treatment which is likely to affect the visual field outcome in the Study Eye other than glaucoma History of diabetes, leukemia, AIDS, uncontrolled systemic high blood pressure, dementia or multiple sclerosis Any disease that is likely to progress within the 3 month time period that might have visual field implications A life threatening or debilitating disease Participation in any study involving a non-FDA approved investigational drug (IND) within the past month, or ongoing participation in a study with a non-FDA approved or cleared investigational device (IDE) Concomitant use of hydrochloroquine and/or chloroquine

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Glaucoma<br>Early, moderate or advanced glaucoma, glaucoma suspects or pre-perimetric glaucoma will perform OCT scanning and HFA perimetry | Device: OCT scanning and HFA perimetry<br>* Imaging of the optic nerve and nerve fiber layer / measurement of visual field<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retinal nerve fiber layer average thickness | Specificity comparison of results from the five visits will be made. Analysis of variance will be used to determine repeatability and reproducibility - results in microns. | less than 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuroretinal rim thickness | Specificity comparison of results from the five visits will be made. Analysis of variance will be used to determine repeatability and reproducibility - results in millimeters squared. | less than 3 months | 
| Mean deviation of visual field | Specificity comparison of results from the five visits will be made. Analysis of variance will be used to determine repeatability and reproducibility - results in decibels. | less than 3 months | 
| Pattern standard deviation of the visual field | Specificity comparison of results from the five visits will be made. Analysis of variance will be used to determine repeatability and reproducibility - results in decibels. | less than 3 months |