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Retinal Imaging Using NOTAL-OCT V2.5

Sponsor
Notal Vision Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT03600519
Collaborator
(none)
87
Enrollment
1
Location
17.3
Actual Duration (Months)
5
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Device: 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

Study Design

Study Type:
Observational
Actual Enrollment :
87 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Retinal Imaging Using NOTAL-OCT V2.5
Actual Study Start Date :
Jul 22, 2018
Actual Primary Completion Date :
Feb 18, 2019
Actual Study Completion Date :
Jan 1, 2020

Arms and Interventions

Arm Intervention/Treatment
AMD Patients

OCT scan

Device: NOTAL OCT V2.5
AMD Patients
Other Names:
  • OCT scan

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The level of agreement between NOTAL-OCT V2.5 and commercial OCT in detecting fluid [less than an hour]

      measurements of retinal thickness.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    1. Exclusion Criteria:

    2. AMD and DR in the same SE

    3. Evidence of macular disease other than AMD or DME in SE

    4. Patient with dilated eye(s)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bnei Zion Haifa Israel 3339123

    Sponsors and Collaborators

    • Notal Vision Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Notal Vision Ltd.
    ClinicalTrials.gov Identifier:
    NCT03600519
    Other Study ID Numbers:
    • BNZ-0060-18
    First Posted:
    Jul 26, 2018
    Last Update Posted:
    Nov 13, 2020
    Last Verified:
    Oct 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Nov 13, 2020