NCT03969303

Brief Summary

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. 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. 2.To evaluate patient experience when self-operating the Notal-OCT V2.5.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
287

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 20, 2018

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

October 23, 2018

Completed
7 months until next milestone

First Posted

Study publicly available on registry

May 31, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 11, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 4, 2019

Completed
Last Updated

November 12, 2020

Status Verified

October 1, 2020

Enrollment Period

9 months

First QC Date

October 23, 2018

Last Update Submit

November 10, 2020

Conditions

AMD - Age-Related Macular DegenerationDiabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

  • Comparison of presence/absence of fluid on OCT images from NOTAL-OCT v.2.5 device with a commercial OCT device, in AMD (Age-related Macular Degeneration) patients

    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.

    less than an hour

Secondary Outcomes (2)

  • Comparison of presence/absence of fluid on OCT images from NOTAL-OCT v.2.5 device with a commercial OCT device, in DR (Diabetic Retinopathy) patients

    less then an hour

  • Patient experience using the NOTAL-OCT v.2.5 device

    less than an hour

Study Arms (1)

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).

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

Interventions

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

OCT SCAN

NOTAL OCT v.2.5 and Commercial OCT on AMD Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

AMD and DME patients

You may qualify if:

  • Ability and willingness to give informed consent (IC)
  • 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

You may not qualify if:

  • \- Any ophthalmic or systemic condition that in the opinion of the investigator would preclude the patient from participating in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Elman Retina Group, PA

Baltimore, Maryland, 21237, United States

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Michael Elman

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2018

First Posted

May 31, 2019

Study Start

October 20, 2018

Primary Completion

July 11, 2019

Study Completion

October 4, 2019

Last Updated

November 12, 2020

Record last verified: 2020-10

Locations

US(1)