Glaucoma HFA / OCT Specificity Study

Carl Zeiss Meditec, Inc.1 site in 1 country90 target enrollmentMarch 2016

ConditionsGlaucoma

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Glaucoma
Sponsor: Carl Zeiss Meditec, Inc.
Enrollment: 90
Locations: 1
Primary Endpoint: Retinal nerve fiber layer average thickness
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2016

End Date

September 2016

Last Updated

10 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Carl Zeiss Meditec, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Retinal nerve fiber layer average thickness

Time Frame: 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.