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

NCT03587454 | Completed

• 1 other identifier: Pro20140001070
• Study Type: interventional
• Target: 107
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Teleglaucoma; Teleophthalmology; Glaucoma

Keywords

teleglaucoma; teleophthalmology

Outcome Measures

Primary Outcomes (1)

• Comparison of diagnosis and management in Teleglaucoma and conventional care

  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)

  24 months

Secondary Outcomes (4)

• Assessment of diagnostic tools during teleglaucoma: Visual acuity

  12 months

• Assessment of diagnostic tools during teleglaucoma: Tonometry

  12 months

• Assessment of diagnostic tools during tele glaucoma: Optic nerve

  12 months

• Assessment of diagnostic tools during tele glaucoma: Optical Coherence Tomography

  12 months

Study Arms (1)

Tele-Glaucoma arm

EXPERIMENTAL

Subjects enrolled in tele-glaucoma arm for remote assessment

Diagnostic Test: Teleglaucoma

Interventions

Teleglaucoma DIAGNOSTIC_TEST

Subjects are evaluated through a teleglaucoma protocol then by physical presence in a glaucoma clinic

Also known as: teleophthalmology

Tele-Glaucoma arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients with glaucoma or who are glaucoma suspects

You may not qualify if:

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

Sponsors & Collaborators

• Rutgers University: lead
• New Jersey Health Foundation: collaborator

Related Publications (1)

• Chandrasekaran S, Kass W, Thangamathesvaran L, Mendez N, Khouri P, Szirth BC, Khouri AS. Tele-glaucoma versus clinical evaluation: The New Jersey Health Foundation Prospective Clinical Study. J Telemed Telecare. 2020 Oct;26(9):536-544. doi: 10.1177/1357633X19845273. Epub 2019 May 28.

  PMID: 31138016 BACKGROUND

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Albert S Khouri, MD

  Rutgers University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking Details: Investigators in teleglaucoma and conventional glaucoma clinics are masked to one another
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Prospective sequential enrolment in teleglaucoma then conventional glaucoma clinical care

Study Record Dates

• First Submitted: May 21, 2018
• First Posted: July 16, 2018
• Study Start: August 1, 2016
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: August 23, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share