Status:
UNKNOWN
Glaucoma HFA / OCT Specificity Study
Lead Sponsor:
Carl Zeiss Meditec, Inc.
Conditions:
Glaucoma
Eligibility:
All Genders
40-80 years
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.
Eligibility Criteria
Inclusion
- 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
- • 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
Key Trial Info
Start Date :
March 1 2016
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2016
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT02708082
Start Date
March 1 2016
End Date
September 1 2016
Last Update
March 15 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Carl Zeiss Meditec, Inc.
Dublin, California, United States, 94568