An observational study in Retinal Neovascularization, sponsored by Notal Vision Inc.. Completed at 2 sites in United States. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2021-11-29.
Sponsored by Notal Vision Inc. · Observational
The purpose of this study is to evaluate the ability of subjects with NV-AMD to perform sequential daily self-imaging of their eyes with the self-operated Notal Home OCT device in their homes for 90 days without on-site supervision. The study will include up to 15 subjects.
Office Visit screening visit:
The following data will be collected for each study subject:
a .Subject's DOB (if allowed) or age b. Gender c .Race d. Ethnicity
The following data will be collected for the study eye(s):
i. Cataract ii. Glaucoma iii. Dry Eye iv. Other macula findings
Home Set-up with Remote Assistance (Day 0)
Following confirmation of subject eligibility at the Enrollment visit and the subject is enrolled in the study:
In-Home Phase (Day 0 to Day 90) Following set-up of the Notal Home OCT,
If an eye cannot calibrate during 5 separate attempts or fails to test 5 consecutive times, the subject will be notified by the NVDC to discontinue self-imaging this eye. If there is a fellow eye also enrolled in the study, the fellow eye will continue
Weekly Review of Notal Home OCT Images by the PI:
The physician will review patient images on a weekly basis to perform an assessment of daily fluid status and document their observations in the CRF.
Routine Care Visits:
Routine care visits may be conducted at the investigator's discretion. The following procedures will be performed at the routine care visits: BCVA, Spectralis or Cirrus OCT, 3. Initiate treatment, if necessary, and document which anti-VEGF drug is used.
At Office Exit Visit (approximately 90 days after Day 0)
Subjects will return to the clinic for an office visit approximately ninety (90) days after the Day 0 (Home Set-up) Visit. At this visit, the exams will be conducted in the following order:
23 studies on the registry are indexed under Retinal Neovascularization; 2 are open to participants now.
Browse Retinal Neovascularization studies →Notal Vision Inc. is the lead sponsor of 9 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population will include approximately fifteen (15) subjects diagnosed with NV-AMD in at least one eye with initiation of anti-VEGF treatment within the past 6 months, at treatment intervals 8 weeks or less, in the NV-AMD eye. At least 50% of the subjects in each of the two study sites with active NV-AMD at time of enrollment in at least one eye, defined as presence of intra- and/or subretinal fluid as seen on the office OCT. Approximately 50% of the eyes with fluid will have intra retinal fluid and at approximately 50% will have sub retinal fluid. Eyes may have both types of fluid.
Exclusion Criteria:
Percentage of successful imaging attempts during daily testing.
Time frame: 90 days
Percentage of eyes successfully completed the set up and calibration
Time frame: 10-15 minutes
Percentage of volume scans with Manufacturer Image quality Index (MSI) >=2 (in a scale of 0-7, where 2 is a pre-defined acceptable-MSI cutoff)
Time frame: 90 days
Percentage of eligible B-scans out of the maximum 88 in each volume scan during daily testing
Time frame: 90 days
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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Notal Vision Inc.