Study of the Modification of the Retinal Nerve Fiber Layer in Patients Treated With Intravitreous Injection of Anti-VEGF
NCT02876198
Eye Diseases, Metaplasia
Lyon, France
View Trial DetailsNCT Number: NCT04650672
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.
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Notify Me55 year and older
All sexes
Observational
Ophthalmic Cons. of Boston, Boston, Massachusetts, United States
Office Visit screening visit:
a .Subject's DOB (if allowed) or age b. Gender c .Race d. Ethnicity
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 90 days
Time frame: 10-15 minutes
Time frame: 90 days
Time frame: 90 days
Notal Vision Inc.
Industry
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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