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Feasibility of Teleglaucoma Versus Conventional Clinical Evaluation for Diagnostic Accuracy and Management Recommendations in Patients With Glaucoma (Teleglaucoma)

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ClinicalTrials.gov Identifier: NCT03587454
Recruitment Status : Active, not recruiting
First Posted : July 16, 2018
Last Update Posted : July 16, 2018
Sponsor:
Collaborators:
New Jersey Health Foundation
Fund for the New Jersey Blind
Information provided by (Responsible Party):
Albert S Khouri, Rutgers University

Brief Summary:
Telemedicine allows screening of subjects with limited access to eye care. Failure of screenees to come for full examination was identified as a serious problem. Teleglaucoma should allow a single physician access to screenees in real time. The investigators aim to test the technical feasibility of developing a system for teleglaucoma that will allow a physician real time access to patient information and images and compare it to traditional physical presence evaluation in glaucoma clinics. This system can be applied during telemedicine for glaucoma and other vision threatening diseases.

Condition or disease Intervention/treatment Phase
Teleglaucoma Teleophthalmology Glaucoma Diagnostic Test: Teleglaucoma Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Sequential Assignment
Intervention Model Description: Prospective sequential enrolment in teleglaucoma then conventional glaucoma clinical care
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Investigators in teleglaucoma and conventional glaucoma clinics are masked to one another
Primary Purpose: Diagnostic
Official Title: TELEGLAUCOMA: THE NJ HEALTH FOUNDATION STUDY a Prospective, Single Site, Masked Study Comparing the Diagnostic Accuracy and Management Recommendations of Teleglaucoma to Conventional Clinical Care in Patients With Glaucoma
Actual Study Start Date : August 2016
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma


Intervention Details:
  • Diagnostic Test: Teleglaucoma
    Subjects are evaluated through a teleglaucoma protocol then by physical presence in a glaucoma clinic
    Other Name: teleophthalmology


Primary Outcome Measures :
  1. Comparison of diagnosis and management in Teleglaucoma and conventional care [ Time Frame: 24 months ]

    Qualitative categorical outcome:

    Glaucoma Diagnosis, Management and follow up are clinical determinations by the investigator that are based on the overall clinical evaluation of the subject

    Diagnosis: A. no glaucoma B. confirmed glaucoma

    Management: A. maintain current therapy, B. advance therapy (additional glaucoma medication or surgical glaucoma intervention), C. no therapy needed

    Follow up: A. urgent (less than 4 weeks from time of evaluation) B. routine (more than 4 weeks from time of evaluation)



Secondary Outcome Measures :
  1. Assessment of diagnostic tools during teleglaucoma: Visual acuity [ Time Frame: 12 months ]

    Quantitative outcome:

    Visual Acuity will be measured on the Snellen chart and then converted to a Log MAR scale (Logarithm of the Minimal Angle of Resolution scale= Log MAR scale). Log MAR scale:

    0.0 to 2.0 units (in increments of 0.2) with 0.0 units representing 20/20 visual acuity (normal vision) and higher numbers representing worse visual acuity (2.0 units representing poor vision of 20/2000)


  2. Assessment of diagnostic tools during teleglaucoma: Tonometry [ Time Frame: 12 months ]

    Quantitative outcome:

    Tonometry will be measured using a Goldmann applanation tonometer and a puff tonometer. All measurements will be in mm Hg, range 0.0-60.0 mm Hg (in increments of 1 mm Hg). Normal range is 6-21 mm Hg. Measurements below 6 and above 21 mm Hg are considered outside the normal range.


  3. Assessment of diagnostic tools during tele glaucoma: Optic nerve [ Time Frame: 12 months ]

    Quantitative outcome:

    Vertical and Horizontal cup-to-disc rations 0.0-1.0 (in increments of 0.1) will be measured. Ratio>0.6 are considered higher risk for glaucoma.

    All measurements will be made by investigators on a high resolution monitor in a dark room. Investigators will be masked to one another assessments in instances were multiple readings are obtained. Images will be presented in a random order when multiple measures are obtained. Other Anterior and posterior segment pathology will be qualitatively noted (cataract, narrow angle, cornea pathology, diabetic retinopathy, age related macular degeneration, other).


  4. Assessment of diagnostic tools during tele glaucoma: Optical Coherence Tomography [ Time Frame: 12 months ]

    Quantitative outcome:

    Optical Coherence Tomography (OCT) will be used to obtain images of the anterior and posterior ocular segments.

    Quantitative measures in micron: 0-900 micron (+/- 5 micron) will be recorded for the cornea, optic nerve and retina. The range of normal is based on reference data that is age and racially determined.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients with glaucoma or who are glaucoma suspects

Exclusion Criteria:

  • Physical limitations precluding image acquisition like the inability to position for imaging or the inability to acquire images/testing

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): NCT03587454


Sponsors and Collaborators
Rutgers University
New Jersey Health Foundation
Fund for the New Jersey Blind
Investigators
Principal Investigator: Albert S Khouri, MD Rutgers University

Responsible Party: Albert S Khouri, Associate Professor, Rutgers University
ClinicalTrials.gov Identifier: NCT03587454     History of Changes
Other Study ID Numbers: Pro20140001070
First Posted: July 16, 2018    Key Record Dates
Last Update Posted: July 16, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Albert S Khouri, Rutgers University:
teleglaucoma
teleophthalmology

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases