Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 23 of 1614 for:    glaucoma

Human Optokinetic Contrast Device (HOCD) to Measure Visual Function and Identify Patients With and Without Glaucoma (HOCD)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02014597
Recruitment Status : Recruiting
First Posted : December 18, 2013
Last Update Posted : January 18, 2018
Sponsor:
Information provided by (Responsible Party):
Benjamin Frankfort, MD, PhD, Baylor College of Medicine

Brief Summary:
The purpose of this study is to determine if an optokinetic contrast detection device is sufficient to measure contrast sensitivity and to distinguish between patients with and without glaucoma.

Condition or disease Intervention/treatment Phase
Glaucoma Device: HOCD Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Use of a Novel, Objective Optokinetic Contrast Device to Determine Scotopic Range Visual Function and Discriminate Between Patients With and Without Glaucoma
Study Start Date : May 2015
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Experimental: Normal - No glaucoma
HOCD
Device: HOCD
comparison of HOCD results between subjects with and without glaucoma

Experimental: Glaucoma
HOCD
Device: HOCD
comparison of HOCD results between subjects with and without glaucoma




Primary Outcome Measures :
  1. Estimated contrast sensitivity in log units [ Time Frame: Study 1: Measured on the day of enrollment/testing. Study 2: Measured on the day of enrollment and again 1 month later. ]
    The HOCD will be used to measure estimated contrast sensitivity in log units for all patients at all time points.


Secondary Outcome Measures :
  1. Distinguish patients with and without glaucoma (statistically different log units of contrast sensitivity) [ Time Frame: Study 1: After enrolling/testing of 5, 20, and 40 patients (approximately 2, 6, and 12 weeks). Study 2: After testing 50 patients (approximately 1 year) and again after testing 100 patients (approximately 2 years) ]
    Differences in estimated contrast sensitivity will be assessed between patients with and without glaucoma to see if the HOCD can distinguish patients with and without the disease and can distinguish the severity of the disease among patients known to have it.

  2. Compare contrast sensitivity measured with the HOCD (log units of contrast sensitivity) to white on white sensitivity (in decibels) via automated perimetry [ Time Frame: Study 1: After enrolling/testing of 5, 20, and 40 patients (approximately 2, 6, and 12 weeks). Study 2: After testing 50 patients (approximately 1 year), after testing 100 patients (approximately 2 years), and 5 years later. ]
    Estimated contrast sensitivity will be assessed with the HOCD and then compared to automated perimetry results. As automated perimetry is used to diagnose and stage glaucoma this allows for comparison to standard of care. For patients with glaucoma this will be done during both Study 1 and Study 2. For normal controls, this will only be performed as part of Study 2.

  3. Compare contrast sensitivity measured with the HOCD (log units of contrast sensitivity) to contrast sensitivity testing (log units of contrast sensitivity) via Pelli Robson Contrast Sensitivity Chart testing. [ Time Frame: Study 2: After testing 50 patients (approximately 1 year), and after testing 100 patients (approximately 2 years). ]
    Estimated contrast sensitivity will be assessed with the HOCD and then compared to Pelli Robson Contrast Sensitivity Chart results. As the Pelli Robson Contrast Sensitivity Chart is the current standard for measuring contrast sensitivity this allows for comparison to standard of care.


Other Outcome Measures:
  1. Tolerance of testing as measured via questionnaire [ Time Frame: Study 1: On the day of enrollment/testing. Study 2: One month after enrollment during the second study visit. ]
    Patients will be asked to relate their experiences with the device/test to determine how well it is tolerated.



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:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Normal controls for Study 1

  1. Male or Female
  2. age 18 or older
  3. Corrected visual acuity 20/40 or better in both eyes.

Normal Controls for Study 2

  1. Male or Female
  2. age 50 or older
  3. IOP (intraocular pressure) 21 or less in both eyes
  4. Corrected visual acuity 20/40 or better in both eyes.

Subjects with glaucoma/ocular hypertension

  1. Male or Female
  2. Age 50 or older
  3. Defined as IOP> 21 without medication on two or more clinic visits in one or both eyes
  4. Corrected visual acuity 20/40 or better
  5. Normal optic nerves
  6. Normal automated perimetry in both eyes

Subjects who are glaucoma/glaucoma suspects

  1. Male or Female
  2. Age 50 or over
  3. Increased optic nerve cupping in one or both eyes regardless of IOP
  4. Corrected visual acuity 20/40 or better
  5. Normal automated perimetry in both eyes

Subjects with early to moderate glaucoma

  1. Male or female
  2. Age 50 or over
  3. Increased optic nerve cupping regardless of IOP in one or both eyes
  4. Corrected visual acuity 20/40 or better in both eyes
  5. Early to moderate perimetric changes defined as a mean deviation (MD) no less than -7.5 and a pattern standard deviation (PSD) no greater than +7.5 in the worse eye.

Subjects with moderate to advanced glaucoma

  1. Male of Female
  2. Age 50 or older
  3. Increased optic nerve cupping regardless of IOP in one or both eyes
  4. Grossly abnormal automated perimetry (MD less than -7.5 or PSD greater than +7.5 in the worse eye)
  5. Best-corrected visual acuity of 20/40 or better in both eyes

Exclusion Criteria:

  • Normal Controls (both studies):

    1. glaucoma or glaucoma suspicion in either eye
    2. IOP > 21 in either eye
    3. History of use of IOP-reducing drops in either eye except temporarily following cataract extraction
    4. History of any ocular surgery except cataract extraction or refractive surgery (LASIK, PRK, or equivalent) in either eye
    5. Retinal disease in either eye
    6. Abnormal measured automated perimetry in either eye
    7. Abnormal measured contrast sensitivity in either eye

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): NCT02014597


Contacts
Layout table for location contacts
Contact: Benjamin J. Frankfort, M.D., Ph.D. 713-798-6100 frankfor@bcm.edu
Contact: April Leger 713-798-4123 april.leger@bcm.edu

Locations
Layout table for location information
United States, Texas
Alkek Eye Center, Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: April Leger    713-798-4123    april.leger@bcm.edu   
Contact: Cindy Dorenbach    713-798-4037    ctanz@bcm.edu   
Principal Investigator: Benjamin J. Frankfort, M.D., PhD         
Sub-Investigator: Peter T. Chang, M.D.         
Sub-Investigator: Yvonne I. Chu, M.D.         
Sub-Investigator: Silvia Orengo-Nania, M.D.         
Sub-Investigator: Samuel Wu, PhD         
Sub-Investigator: Cameron Cowan         
Sub-Investigator: Mitchell Weikert, MD         
Sub-Investigator: Margaret Olfson         
Sponsors and Collaborators
Benjamin Frankfort, MD, PhD
Investigators
Layout table for investigator information
Principal Investigator: Benjamin J. Frankfort, M.D. PhD. Baylor College of Medicine

Layout table for additonal information
Responsible Party: Benjamin Frankfort, MD, PhD, Assistant Professor, Principal Investigator, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT02014597     History of Changes
Other Study ID Numbers: H-30109
First Posted: December 18, 2013    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018

Keywords provided by Benjamin Frankfort, MD, PhD, Baylor College of Medicine:
Glaucoma

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