Clinical trial NCT03969303: NOTAL-OCT V.2.5 vs Commercial OCT in AMD Patients
Official title: Comparison Between Retinal Images Captured by NOTAL-OCT V2.5 and Zeiss Cirrus / Heidelberg Spectralis SD OCT - Study Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: AMD - Age-Related Macular Degeneration
Diabetic Macular Edema
Lead sponsor: Notal Vision Inc.
Sponsor class: INDUSTRY
Collaborators: name: Elman Retina Group
First posted: 2019-05-31
Enrollment: 287
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: AMD and DME patients

Brief summary: Primary objective:

To evaluate the level of agreement between the NOTAL-OCT V2.5 and a commercial OCT in the presence of fluid as identified in the OCT images, in the central 10 degrees of the macula in AMD (Age-related Macular Degeneration) patients.

Secondary objectives:

1. To evaluate the level of agreement between the NOTAL-OCT V2.5 and a commercial OCT in the presence of fluid as identified in the OCT images, in the central 10 degrees of the macula in DME (Diabetic Macular Edema) patients.
2. To evaluate patient experience when self-operating the Notal-OCT V2.5.

Detailed description: To evaluate the sensitivity and specificity regarding the presence and absence of fluid on OCT images of AMD patients. OCT images from the central 10 degrees of the macula in AMD patients will be obtained using the NOTAL OCT v.2.5 and a commercial OCT device (Zeiss Cirrus / Heidlberg SPECTRALIS). These images will be evaluated for the presence/absence of fluid in the images by a human grader. The sensitivity and specificity will be determined by comparison of the presence/absence of fluid in the NOTAL OCT v2.5 images with the presence/absence of fluid in the commercial OCT images.

To evaluate the sensitivity and specificity regarding the presence and absence of fluid on OCT images of DME patients. OCT images from the central 10 degrees of the macula in DME patients will be obtained using the NOTAL OCT v.2.5 and a commercial OCT device (Zeiss Cirrus / Heidlberg SPECTRALIS). These images will be evaluated for the presence/absence of fluid in the images by a human grader. The sensitivity and specificity will be determined by comparison of the presence/absence of fluid in the NOTAL OCT v2.5 images with the presence/absence of fluid in the commercial OCT images.

Patients will complete a questionnaire regarding the usability of the NOTAL-OCT v.2.5 device

Eligibility criteria: Inclusion Criteria:

* Ability and willingness to give informed consent (IC)
* 18 years of age or older
* Diagnosis of AMD (age-related macular degeneration) and/or DME (diabetic macular edema) in the study eye as confirmed by the investigator and recorded in the patient's clinical record
* Ability to undergo OCT (optical coherence tomography) testing
* Visual acuity of 20/400 Snellen (6/120) or better in the study eye

Exclusion Criteria:

- Any ophthalmic or systemic condition that in the opinion of the investigator would preclude the patient from participating in the study.

Primary outcomes:
measure: Comparison of presence/absence of fluid on OCT images from NOTAL-OCT v.2.5 device with a commercial OCT device, in AMD (Age-related Macular Degeneration) patients
timeFrame: less than an hour
Secondary outcomes:
measure: Comparison of presence/absence of fluid on OCT images from NOTAL-OCT v.2.5 device with a commercial OCT device, in DR (Diabetic Retinopathy) patients
timeFrame: less then an hour
measure: Patient experience using the NOTAL-OCT v.2.5 device
timeFrame: less than an hour
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Elman Retina Group, PA
state: Maryland
Study officials:
affiliation: Michael Elman, M.D. 9114 Philadelphia Rd #310 Baltimore, Maryland 21237
name: Michael Elman
role: PRINCIPAL_INVESTIGATOR
References: