Glaucoma HFA / OCT Specificity Study

NCT ID: NCT02708082

Last Updated: 2016-03-15

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2016-09-30

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.

Conditions

Glaucoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Glaucoma

Early, moderate or advanced glaucoma, glaucoma suspects or pre-perimetric glaucoma will perform OCT scanning and HFA perimetry

OCT scanning and HFA perimetry

Intervention Type: DEVICE

Imaging of the optic nerve and nerve fiber layer / measurement of visual field

Interventions

OCT scanning and HFA perimetry

Imaging of the optic nerve and nerve fiber layer / measurement of visual field

Intervention Type: DEVICE

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Carl Zeiss Meditec, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Callan

Role: STUDY_DIRECTOR

Carl Zeiss Meditec, Inc.

Locations

Carl Zeiss Meditec, Inc.

Dublin, California, United States

Countries

United States

Central Contacts

Thomas Callan

Role: CONTACT

9255574834

Facility Contacts

T Callan

Role: primary

Other Identifiers

COMBO-2015-1

Identifier Type: -

Identifier Source: org_study_id