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

NCT02014597 | Terminated Results

• 1 other identifier: H-30109
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma

Keywords

Glaucoma

Outcome Measures

Primary Outcomes (1)

• Estimated Contrast Sensitivity in Log Units (logCS)

  The HOCD willl be used to estimate the logCS of both eyes in both dark (scotopic) and light (photopic) conditions.

  Study 1: Measured on the day of enrollment - reported only for those enrolled (early Termination). Study 2: Measured on the day of enrollment and 1 month later - not started (early Termination).

Secondary Outcomes (3)

• Compare Log Contrast Sensitivity in Subjects With and Without Glaucoma

  Study 1: Measured on the day of enrollment - reported only for those enrolled (early Termination). Study 2: Measured on the day of enrollment and 1 month later - not started (early Termination).

• Compare Log Contrast Sensitivity Measured With the HOCD to White on White Sensitivity Via Automated Perimetry

  Study 1: Measured on the day of enrollment - reported only for those enrolled (early Termination). Study 2: Measured on the day of enrollment - not started (early Termination).

• Compare Contrast Sensitivity Measured With the HOCD to Contrast Sensitivity Testing Via Pelli Robson Contrast Sensitivity Chart Testing.

  Study 2: Measured 1 month after the day of enrollment - not started (early Termination).

Other Outcomes (1)

• Tolerance of Testing as Measured Via Questionnaire

  Study 1: Measured on the day of enrollment - reported only for those enrolled (early Termination). Study 2: Measured 1 month after the day of enrollment - not started (early Termination).

Study Arms (2)

Normal - No glaucoma

EXPERIMENTAL

HOCD

Device: HOCD

Glaucoma

EXPERIMENTAL

HOCD

Device: HOCD

Interventions

HOCD DEVICE

feasibility of HOCD and comparison of HOCD results between subjects with and without glaucoma

Glaucoma; Normal - No glaucoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Normal controls for Study 1
• Male or Female
• age 18 or older
• Corrected visual acuity 20/40 or better in both eyes.
• Normal Controls for Study 2
• Male or Female
• age 50 or older
• IOP (intraocular pressure) 21 or less in both eyes
• Corrected visual acuity 20/40 or better in both eyes.
• Subjects with glaucoma/ocular hypertension
• Male or Female
• Age 50 or older
• Defined as IOP\> 21 without medication on two or more clinic visits in one or both eyes
• Corrected visual acuity 20/40 or better
• Normal optic nerves

You may not qualify if:

• Normal Controls (both studies):
• glaucoma or glaucoma suspicion in either eye
• IOP \> 21 in either eye
• History of use of IOP-reducing drops in either eye except temporarily following cataract extraction
• History of any ocular surgery except cataract extraction or refractive surgery (LASIK, PRK, or equivalent) in either eye
• Retinal disease in either eye
• Abnormal measured automated perimetry in either eye
• Abnormal measured contrast sensitivity in either eye

Sponsors & Collaborators

• Benjamin Frankfort, MD, PhD: lead

Study Sites (1)

Alkek Eye Center, Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Results Point of Contact

• Title: Dr. Benjamin Frankfort
• Organization: Baylor College of Medicine

benjamin.frankfort@bcm.edu

713-798-3453

Study Officials

• Benjamin J. Frankfort, M.D. PhD.

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Principal Investigator

Study Record Dates

• First Submitted: November 26, 2013
• First Posted: December 18, 2013
• Study Start: May 1, 2015
• Primary Completion: August 22, 2017
• Study Completion: August 22, 2017
• Last Updated: May 11, 2023
• Results First Posted: November 18, 2020

Record last verified: 2023-05

Locations

US (1)