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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: Completed study of Diabetic Macular Edema and AMD - Age-Related Macular Degeneration, sponsored by Notal Vision.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 287 participants |
| Start Date | 2018-10-20 |
| Est. Completion | 2019-10-04 |
What the finished NCT03969303 record still lists
NCT03969303 is an observational study that tracks outcomes without assigning an intervention. The registered 287 participants enrollment target is mid-sized for trials with a published cap, below the 3,790-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (92% lower).
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 a single indexed study location in 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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Where NCT03969303's enrollment target sits among peer trials
287 16th of 63 higher than 48 of 63 other Diabetic Macular Edema trials
participants (enrollment target), bucketed by value
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