Glaucoma HFA / OCT Specificity Study

Glaucoma Clinical Trial

Official title:

Glaucoma HFA / OCT Specificity Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02708082
• Other study ID #: COMBO-2015-1
• Status: Not yet recruiting
• Phase: N/A
• First received: February 24, 2016
• Last updated: March 9, 2016
• Start date: March 2016
• Est. completion date: September 2016

Study information

• Verified date: March 2016
• Source: Carl Zeiss Meditec, Inc.
• Contact: Thomas Callan
• Phone: 9255574834
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: September 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Glaucoma

Intervention

Device:
• OCT scanning and HFA perimetry
Imaging of the optic nerve and nerve fiber layer / measurement of visual field

Locations

Country	Name	City	State
United States	Carl Zeiss Meditec, Inc.	Dublin	California

Sponsors (1)

Lead Sponsor	Collaborator
Carl Zeiss Meditec, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No