Single In-Clinic Encounter With the Notal Vision Home OCT by DME Patients
Evaluation of Repeated, In-Clinic, Self-Imaging by DME Patients Using the Notal Vision Home OCT
1 other identifier
observational
18
1 country
1
Brief Summary
In this clinical study the Notal Vision Home OCT (NVHO) Monitoring System will be used to evaluate the ability of patients diagnosed with DME to perform sequential self-images of their eyes with the self-operated NVHO device in a home simulated environment in the doctor's office. The study population will include up to 30 patients, with DR in at least one eye at the time of enrollment. All subjects will be enrolled at one site in Israel.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2022
Shorter than P25 for all trials
1 active site
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
First Submitted
Initial submission to the registry
June 9, 2022
CompletedFirst Posted
Study publicly available on registry
June 14, 2022
CompletedStudy Start
First participant enrolled
June 29, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2023
CompletedJune 15, 2023
June 1, 2022
5 months
June 9, 2022
June 14, 2023
Conditions
Outcome Measures
Primary Outcomes (7)
NVHO Total Retinal Fluid (TRF)
volume (nl) measured by NOA (automatic OCT analyzer)
5 minutes
NVHO Intra-Retinal Fluid (IRF)
volume (nl) measured by NOA (automatic OCT analyzer)
5 minutes
NVHO Sub-Retinal Fluid (SRF)
volume (nl) measured by NOA (automatic OCT analyzer)
5 minutes
Zeiss Cirrus OCT Total Retinal Fluid (TRF)
volume (nl) measured by a human reader
10 minutes
Zeiss Cirrus OCT Intra-Retinal Fluid (IRF)
volume (nl) measured by a human reader
10 minutes
Zeiss Cirrus OCT Sub-Retinal Fluid (SRF)
volume (nl) measured by a human reader
10 minutes
Scanning session completion status
complete/incomplete
5 minutes
Eligibility Criteria
The study population will include up to thirty (30) patients, with DR in at least one eye at the time of enrollment. All subjects will be enrolled at one (1) site in Israel. The subjects must meet all inclusion / exclusion criteria. Approximately 90% of the enrolled subjects should have at least one eye with DME at the time of enrollment.
You may qualify if:
- Ability to speak, read and understand Hebrew.
- Ability to understand and agree to contents of informed consent.
- Eighteen (18) years of age or older at the time of Informed Consent.
- Subjects diagnosed with DR (Diabetic Retinopathy) in at least one eye, with or without DME
- Best corrected Visual Acuity of 20/320 (6/96) or better in eyes participating at the study.
You may not qualify if:
- Subjects with dilated pupils.
- Subjects with other retinal disease requiring steroidal or anti-VEGF injections.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assuta Hashalom
Tel Aviv, Israel
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
June 9, 2022
First Posted
June 14, 2022
Study Start
June 29, 2022
Primary Completion
November 30, 2022
Study Completion
March 30, 2023
Last Updated
June 15, 2023
Record last verified: 2022-06