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NCT03969303 · ClinicalTrials.gov registry record

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

A clinical trial of Diabetic Macular Edema and AMD - Age-Related Macular Degeneration, sponsored by Notal Vision.

Completed
Registry status
287
Enrollment target
1
Study location

NCT03969303 is a study of Diabetic Macular Edema and AMD - Age-Related Macular Degeneration that has completed, run by Notal Vision. The registered enrollment target is 287 participants, below the 3,790-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03969303, a study of Diabetic Macular Edema and AMD - Age-Related Macular Degeneration, has completed, sponsored by Notal Vision.

COMPLETED
Registry status
287 participants
Enrollment target
1
Study location

Study 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. 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.

Interventions

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

Study Locations (1)

Maryland

  • Elman Retina Group, PA - Baltimore

Trial Details

FieldValue
Enrollment Target 287 participants
Start Date 2018-10-20
Est. Completion 2019-10-04

Sponsor

Notal Vision

11 total trials

What the Registry Record Tells You About NCT03969303

The ClinicalTrials.gov registry entry for NCT03969303 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 287 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,790-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (92% lower). The listed sponsor is Notal Vision, which has 11 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Diabetic Macular Edema appearing as the primary indexed condition, and to 1 intervention - of which Notal Vision Optical Coherence Tomography Device Version 2.5 (NOTAL-OCT V2.5) is the first listed.

NCT03969303 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT03969303 about?

NCT03969303 is a clinical study titled "NOTAL-OCT V.2.5 vs Commercial OCT in AMD Patients". 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 leve...

What is the current status of trial NCT03969303?

This trial is currently completed. The enrollment target is 287 participants. The study started on 2018-10-20. Estimated completion is 2019-10-04.

What conditions does trial NCT03969303 study?

This clinical trial studies the following conditions: Diabetic Macular Edema, AMD - Age-Related Macular Degeneration.

What interventions are being tested in trial NCT03969303?

The interventions under investigation include: Notal Vision Optical Coherence Tomography Device Version 2.5 (NOTAL-OCT V2.5) (DEVICE).

Who is sponsoring clinical trial NCT03969303?

This trial is sponsored by Notal Vision, which has 11 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03969303 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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