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NOTAL-OCT V.2.5 vs Commercial OCT in AMD Patients

NCT ID: NCT03969303

Last Updated: 2020-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

287 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-20

Study Completion Date

2019-10-04

Brief Summary

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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

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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

Conditions

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AMD - Age-Related Macular Degeneration Diabetic Macular Edema

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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NOTAL OCT v.2.5 and Commercial OCT on AMD Patients

OCT Images will be obtained in the central 10 degrees of the macula in AMD patients using the NOTAL OCT v.2.5 device and a Commercial device (Zeiss Cirrus/Heidelberg SPECTRALIS).

Notal Vision Optical Coherence Tomography Device Version 2.5 (NOTAL-OCT V2.5)

Intervention Type DEVICE

OCT SCAN

Interventions

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Notal Vision Optical Coherence Tomography Device Version 2.5 (NOTAL-OCT V2.5)

OCT SCAN

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Elman Retina Group

OTHER

Sponsor Role collaborator

Notal Vision Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Elman

Role: PRINCIPAL_INVESTIGATOR

Michael Elman, M.D. 9114 Philadelphia Rd #310 Baltimore, Maryland 21237

Locations

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Elman Retina Group, PA

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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C2018.008

Identifier Type: -

Identifier Source: org_study_id