Retinal Imaging Using NOTAL-OCT

Completed

• Conditions: Diabetic Retinopathy; Age-Related Macular Degeneration
• Interventions: Device: Notal OCT

• Registration Number: NCT03374020
• Lead Sponsor: Notal Vision Ltd.

Brief Summary

Comparison between retinal measurements, done by the Notal-OCT imaging and a commercial OCT (Optical Coherence Tomography)

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-17
• Study First Submitted: 2017-09-11
• Study First Submitted QC: 2017-12-13
• Study First Posted: 2017-12-14
• Primary Completion: 2018-05-14
• Study Completion: 2018-12-01
• Status Verified: 2020-10
• Last Update Submitted: 2020-11-11
• Last Update Posted: 2020-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

1. Ability and agreement to give informed consent (IC)
2. Diagnosis of AMD or DR in SE by OCT
3. Ability to undergo OCT scans
4. VA of 20/160 or better in SE

Exclusion Criteria

1. AMD and DR in the same SE
2. Evidence of macular disease other than AMD or DME in SE

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
DR with macular edema	Notal OCT	-
Intermediate AMD	Notal OCT	-
DR without macular edema	Notal OCT	-
Advanced AMD	Notal OCT	-

Primary Outcome Measures

Name	Time	Method
The level of agreement between NOTAL-OCT and commercial OCT in detecting fluid in the 10 central degrees of the macula.	1 year	OCT B-scans from both devices will be graded for fluid by an eye care professional and results per macula will be analyzed. A binary decision "there is fluid" or "there is no fluid" will be given to each macula (10 central degrees). Then agreement between decisions, commercial and Notal OCT, will be compared