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
|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|
|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|
- Diagnostic Test: Teleglaucoma
Subjects are evaluated through a teleglaucoma protocol then by physical presence in a glaucoma clinicOther Name: teleophthalmology
- 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)
- Assessment of diagnostic tools during teleglaucoma: Visual acuity [ Time Frame: 12 months ]
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)
- Assessment of diagnostic tools during teleglaucoma: Tonometry [ Time Frame: 12 months ]
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.
- Assessment of diagnostic tools during tele glaucoma: Optic nerve [ Time Frame: 12 months ]
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).
- Assessment of diagnostic tools during tele glaucoma: Optical Coherence Tomography [ Time Frame: 12 months ]
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.
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
|Principal Investigator:||Albert S Khouri, MD||Rutgers University|