Glaucoma
Conditions
Brief summary
Study consists of five visits over a one to three month time period.
Detailed description
Each visit consists of optical coherence tomography (OCT) scanning (4 scans ) and two HFA (Humphrey Field Analyzer) visual fields of the study eye only.
Interventions
DEVICEOCT scanning and HFA perimetry
Imaging of the optic nerve and nerve fiber layer / measurement of visual field
Sponsors
Carl Zeiss Meditec, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retinal nerve fiber layer average thickness | less than 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neuroretinal rim thickness | less than 3 months | 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. |
| Mean deviation of visual field | less than 3 months | 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. |
| Pattern standard deviation of the visual field | less than 3 months | 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. |
Countries
United States
Contacts
Primary ContactThomas Callan
Outcome results
None listed