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Retinal Imaging Using NOTAL-OCT V2.5

Retinal Imaging Using NOTAL-OCT V2.5

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03600519
Enrollment
87
Registered
2018-07-26
Start date
2018-07-22
Completion date
2020-01-01
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

AMD

Brief summary

Primary objectives: To compare between retinal measurements, done by the NOTAL-OCT V2.5 device and a commercial OCT. 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. 2. To evaluate the repeatability of the NOTAL-OCT V2.5

Detailed description

Study population: 1. AMD population - intermediate and advanced AMD (with active and nonactive CNV) 2. DR population. Patient with and without DME

Interventions

DEVICENOTAL OCT V2.5

AMD Patients

Sponsors

Notal Vision Ltd.
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

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

Inclusion criteria

1. Inclusion Criteria: a- Ability and agreement to give informed consent (IC) b -Diagnosis of AMD or DR in SE by OCT c- Ability to undergo OCT scans d- VA of 20/400 (6/120) or better in SE 2.

Exclusion criteria

1. AMD and DR in the same SE 2. Evidence of macular disease other than AMD or DME in SE 3. Patient with dilated eye(s)

Design outcomes

Primary

MeasureTime frameDescription
The level of agreement between NOTAL-OCT V2.5 and commercial OCT in detecting fluidless than an hourmeasurements of retinal thickness.

Countries

Israel

Outcome results

None listed

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