Retinal Imaging Using NOTAL-OCT
1 other identifier
observational
33
0 countries
N/A
Brief Summary
Comparison between retinal measurements, done by the Notal-OCT imaging and a commercial OCT (Optical Coherence Tomography)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2017
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
January 17, 2017
CompletedFirst Submitted
Initial submission to the registry
September 11, 2017
CompletedFirst Posted
Study publicly available on registry
December 14, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 14, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedNovember 13, 2020
October 1, 2020
1.3 years
September 11, 2017
November 11, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
The level of agreement between NOTAL-OCT and commercial OCT in detecting fluid in the 10 central degrees of the macula.
OCT B-scans from both devices will be graded for fluid by an eye care professional and results per macula will be analyzed. A binary decision "there is fluid" or "there is no fluid" will be given to each macula (10 central degrees). Then agreement between decisions, commercial and Notal OCT, will be compared
1 year
Study Arms (4)
Intermediate AMD
Advanced AMD
DR without macular edema
DR with macular edema
Interventions
Imaging using Notal OCT
Eligibility Criteria
1. AMD population - intermediate and advanced AMD (with active and non-active CNV) 2. DR population. Patient with and without DME
You may qualify if:
- Ability and agreement to give informed consent (IC)
- Diagnosis of AMD or DR in SE by OCT
- Ability to undergo OCT scans
- VA of 20/160 or better in SE
You may not qualify if:
- AMD and DR in the same SE
- Evidence of macular disease other than AMD or DME in SE
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 11, 2017
First Posted
December 14, 2017
Study Start
January 17, 2017
Primary Completion
May 14, 2018
Study Completion
December 1, 2018
Last Updated
November 13, 2020
Record last verified: 2020-10