Clinical trial NCT02708082: Glaucoma HFA / OCT Specificity Study
Official title: Glaucoma HFA / OCT Specificity Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glaucoma
Lead sponsor: Carl Zeiss Meditec, Inc.
Sponsor class: INDUSTRY
First posted: 2016-03-15
Enrollment: 90
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult males or females 40 to 80 years old with diagnosis of glaucoma, pre-perimetric glaucoma or glaucoma suspect

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 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

Primary outcomes:
measure: Retinal nerve fiber layer average thickness
timeFrame: less than 3 months
Secondary outcomes:
measure: Neuroretinal rim thickness
timeFrame: less than 3 months
measure: Mean deviation of visual field
timeFrame: less than 3 months
measure: Pattern standard deviation of the visual field
timeFrame: less than 3 months
Other outcomes:
Locations:
city: Dublin
country: United States
facility: Carl Zeiss Meditec, Inc.
state: California
Study officials:
affiliation: Carl Zeiss Meditec, Inc.
name: Thomas Callan
role: STUDY_DIRECTOR
References: