Glaucoma HFA / OCT Specificity Study

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

Study Overview

• Status: Unknown
• Conditions: Glaucoma
• Intervention / Treatment: Device: OCT scanning and HFA perimetry

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.

• Study Type: Observational
• Enrollment (Anticipated): 90

Contacts and Locations

• Study Contact: Name: Thomas Callan; Phone Number: 9255574834

Study Locations

• United States
  • California
    • Dublin, California, United States, 94568
      • Carl Zeiss Meditec, Inc.
      • Contact: T Callan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Glaucoma; Early, moderate or advanced glaucoma, glaucoma suspects or pre-perimetric glaucoma will perform OCT scanning and HFA perimetry	Device: OCT scanning and HFA perimetry; Imaging of the optic nerve and nerve fiber layer / measurement of visual field

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retinal nerve fiber layer average thickness	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.	less than 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuroretinal rim thickness	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.	less than 3 months
Mean deviation of visual field	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.	less than 3 months
Pattern standard deviation of the visual field	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.	less than 3 months

Collaborators and Investigators

• Sponsor: Carl Zeiss Meditec, Inc.
• Investigators: Study Director: Thomas Callan, Carl Zeiss Meditec, Inc.

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Anticipated): August 1, 2016
• Study Completion (Anticipated): September 1, 2016

Study Registration Dates

• First Submitted: February 24, 2016
• First Submitted That Met QC Criteria: March 9, 2016
• First Posted (Estimate): March 15, 2016

Study Record Updates

• Last Update Posted (Estimate): March 15, 2016
• Last Update Submitted That Met QC Criteria: March 9, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: COMBO-2015-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No