Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Glaucoma HFA / OCT Specificity Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02708082
Recruitment Status : Unknown
Verified March 2016 by Carl Zeiss Meditec, Inc..
Recruitment status was:  Not yet recruiting
First Posted : March 15, 2016
Last Update Posted : March 15, 2016
Sponsor:
Information provided by (Responsible Party):
Carl Zeiss Meditec, Inc.

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

Condition or disease Intervention/treatment
Glaucoma 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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Glaucoma HFA / OCT Specificity Study
Study Start Date : March 2016
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

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




Primary Outcome Measures :
  1. Retinal nerve fiber layer average thickness [ Time Frame: less than 3 months ]
    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.


Secondary Outcome Measures :
  1. Neuroretinal rim thickness [ Time Frame: less than 3 months ]
    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.

  2. Mean deviation of visual field [ Time Frame: less than 3 months ]
    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.

  3. Pattern standard deviation of the visual field [ Time Frame: less than 3 months ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02708082


Contacts
Layout table for location contacts
Contact: Thomas Callan 9255574834

Locations
Layout table for location information
United States, California
Carl Zeiss Meditec, Inc. Not yet recruiting
Dublin, California, United States, 94568
Contact: T Callan         
Sponsors and Collaborators
Carl Zeiss Meditec, Inc.
Investigators
Layout table for investigator information
Study Director: Thomas Callan Carl Zeiss Meditec, Inc.

Layout table for additonal information
Responsible Party: Carl Zeiss Meditec, Inc.
ClinicalTrials.gov Identifier: NCT02708082     History of Changes
Other Study ID Numbers: COMBO-2015-1
First Posted: March 15, 2016    Key Record Dates
Last Update Posted: March 15, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Glaucoma
Ocular Hypertension
Eye Diseases