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Retinal Imaging Using NOTAL-OCT

Retinal Imaging Using NOTAL-OCT

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03374020
Enrollment
33
Registered
2017-12-14
Start date
2017-01-17
Completion date
2018-12-01
Last updated
2020-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age-Related Macular Degeneration, Diabetic Retinopathy

Brief summary

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

Interventions

DEVICENotal OCT

Imaging using Notal OCT

Sponsors

Notal Vision Ltd.
Lead SponsorINDUSTRY

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The level of agreement between NOTAL-OCT and commercial OCT in detecting fluid in the 10 central degrees of the macula.1 yearOCT 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026