Glaucoma HFA / OCT Specificity Study

Status unconfirmed

Conditions studied: Glaucoma

In brief

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

Key facts

Study ID

NCT02708082

Run by

Carl Zeiss Meditec, Inc.

People needed

90

Starts

2016-03-01

Expected to finish

2016-09-01

Last updated by the study team

2016-03-15

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• • 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

Where it is running

• Carl Zeiss Meditec, Inc. — Dublin, California, United States

Full record on ClinicalTrials.gov

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