Implementation of the NEDS EyeCTester App

Conditions

• Macular Disease
• Optic Nerve Disease
• Visual Pathway Disorder

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• EyeCTester — DEVICE
  Smartphone app that allows vision testing

Study Details

Group 4a and 4b was an FDA trial that showed that patients who have an Amsler grid abnormality on paper, have a similar abnormality on the app. Group 7a and 7b was an FDA trial that showed that normal patients do not have false positives on the Amsler app as well as on the Amsler paper version. Further Vision on the app is slightly better than vision on the standard Sloan near card using a formula (vision is 7/10th of a line better on the app).

Key Dates

Start date

Jan 9, 2019

Status verified

Apr 2026

Primary completion

Dec 31, 2027

Completion

Dec 31, 2028

Study Design

Enrollment

100 participants (estimated)

Arms

• Arm: Groups in General all were done under the wcgIRB, even those that were Practice groups
  Groups 1-3 were practice groups, gathering smartphone app installation, functional and usability feedback in preparation for later phase groups Groups 4a and 4b Cohort 1 and 2 is the FDA application finalized and submitted study groups Group 5-6 currently in continuing clinical trial during FDA application process
• Arm: 1-3,5 Developmental team(1), Technician(2) and Non-Clinical Groups(3) 5. Retinal practice
  Individuals on the developmental team, staff members and outside clinic people 5 Retinal Practice (to do after FDA approval)
• Arm: 4a. Cohort 1. FDA group
  Patients in Neuro-Ophthalmology of Texas (NOT) PLLC practice which has referrals from multiple practices including retinal patients.
• Arm: 4b. Cohort 2. FDA group
  Patients in NOT practice
• Arm: 6 At Home use of app in continuing clinical trial during FDA decision
  Patients are educated on the app at home via app video clips and brochure, and as necessary, online training with COA (ophthalmic assistants/technicians or other trained educators) in order to do remote physiologic vision monitoring or preclinic near vision check.
• Arm: 7a Cohort 1 FDA group responding to AI
  Normal patients were tested with standard near vision tests compared with the smartphone app near vision tests. All patients were trained at home with app videos and by COA via telemedicine before coming to clinic.
• Arm: 7b Cohort 2 FDA group responding to AI
  Normal patients were tested with standard near vision tests compared with the smartphone app near vision tests. All patients were trained at home with app videos and by COA via telemedicine before coming to clinic.

Primary Outcome Measure

Primary Outcome Measure for Groups 4a and 4b: [ Time Frame: Study was conducted for each patient in one day. ]

Locations (1)

Find similar trials in Bellaire, TX

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