Protocol: Home OCT Monitoring System: Feasibility Study
Status: Recruiting
Start Date: 07/13/2021
End Date:  
Clinical Trial ID:  
Public Dataset:  

Full Protocol

Summary Slides


Protocol Summary

Participant area

description

Title

Home OCT Monitoring System: Feasibility Study

Précis

Treatment of retinal vascular diseases with anti-VEGF therapy is a major improvement but at a very high treatment burden and cost for patients and the healthcare system.  The ability to perform daily monitoring of intraretinal fluid and subretinal fluid using a home OCT system offers the opportunity to obtain a detailed assessment of fluid over time.  Understanding retinal and subretinal fluid dynamics for an individual patient may allow customization of treatment that may reduce treatment burden and improve the chance for better long-term VA outcomes.  In addition, daily fluid monitoring could provide a better understanding of the differences between drugs in anatomical and functional outcomes.

Notal Vision has developed an OCT system for at-home use, called Home OCT system.  The Home OCT system has only been used in a few, small in-clinic studies. Large studies are needed to understand the potential utility of home OCT monitoring. However, feasibility of the Home OCT system outside of the clinic must first be assessed prior to implementing monitoring in a large-scale study. This feasibility study will collect information on the logistics of the Home OCT system needed to plan a larger study and will also contribute to the evaluation of fluid patterns between in-office visits. Comparing the Home OCT scans to the SD-OCT scans performed in-office will also provide additional validation of the ability to detect fluid volumes and fluid absence/presence.

 

Objectives and Corresponding Outcomes

Home OCT Use Objectives

  • Develop and assess methods of OCT image transfer to Notal and/or the DRCR Retina Network Coordinating Center and/or the DRCR Retina Network OCT Reading Center
  • Develop and assess methods for transfer of files containing Notal interpretations (presence and volume of intraretinal and subretinal fluid) of OCT images to the Coordinating Center
  • Assess methods and timeliness of OCT image interpretation by Notal
    • Mean time between scan acquisition and fluid measurements (from the AI algorithm) becoming available on web viewer
  • Assess ability of clinic and Notal staff to educate patient about conducting Home OCT monitoring
    • Number of support telephone calls from Notal required to maintain a regular scanning schedule at home or to correct quality issues
  • Assess willingness of patients to participate in a program requiring home OCT monitoring
    • Proportion of participants approached by the site to enroll in study who were not interested in using the device
    • Proportion of participants approached by the site to enroll in study who were not capable of conducting Home OCT monitoring
  • Assess ability of patients to complete home OCT monitoring as specified in the protocol
    • Number of screen failures (participants that were sent the Home OCT device but were unable to initiate self-scanning and were required to return the device to Notal)
    • Proportion of participants who maintained regular scanning (definition TBD) and the frequency of scanning
    • Proportion of good quality scans

 

AMD-Specific Objectives

·         Assess fluid dynamics

o   Gather information to contribute to the database for determining criteria for triggering an alert for a visit to the ophthalmologist

    • Review Surveillance Reports on the Notal OCT Web Viewer
    • Assess the following for intraretinal, subretinal, and total retinal fluid in the 3x3 mm area:
      • Rate of change in fluid on Home OCT between treatments
      • Minimum/maximum fluid volume reached between treatments
      • Fluid presence interval between treatments
      • Fluid-free interval between treatments
      • Fluid regression interval between treatments
      • Fluid increase interval between treatments
      • Cumulative fluid presence interval over 6 months
      • Cumulative fluid-free interval over 6 months
      • Ratio of cumulative presence interval to cumulative free interval

§  Area under the fluid volume curve

§  Persistent fluid yes/no

§  Maximal weekly fluid volume increase rate [nL/week]

§  Number of fluid recurrence events

 

  • Assessment of whether scans obtained on different days would be sufficient for home monitoring
    • Compare information gained on images obtained daily versus information on images 3-7 days apart.

·         Determine agreement of SD-OCT image interpretation by the Reading Center with interpretation of home monitoring OCT images by the Notal OCT Analyzer (NOA) AI algorithm on the days that patients are examined in their ophthalmologist’s office. The agreement will be analyzed for the identification, quantification (where applicable), and localization of intraretinal and subretinal fluid

 

Study Design

Multi-center, prospective study

Number of Sites

3

Population

Key Inclusion Criteria:

  • Age = 55 years

·         Able to read and understand English

·         Has cognitive capacity to provide consent and follow instructions   

·         Participant’s home has a table with a smooth, flat surface close to an outlet to support placement of the device for 6 months (device dimensions are 9.8” wide x 14.2” deep x 16.9” high)

·         Participant will be able to set up the Home OCT device by themselves or with assistance from others (device is 16 pounds without packaging, 17.8 pounds with packaging)

·         Lives in an area with adequate cell phone reception (for the Home OCT data to be properly uploaded to the cloud)

·         Has a telephone number (home or cell) for Notal to call and provide Home OCT assistance and reminders

·         Able and willing to perform daily home OCT monitoring tests for six months without interruption (such as travel of more than 14 days).

·         Able to perform initial self-scan in the 7 days following receipt of the Home OCT device (ships in 3-5 days)

·         No plans to move out of the area in the next six months

  • Active choroidal neovascularization (CNV) due to AMD in at least one eye in which the investigator intends to treat with anti-VEGF
    • AMD defined as presence of at least one large drusen in either eye (determined by investigator)
    • Active CNV defined as presence of intraretinal or subretinal fluid (determined by investigator)
  • Visual acuity of 20/20 to 20/320 (Snellen) or 24 to 88 letters (ETDRS)

 

Key Exclusion Criteria

·         Previous treatment for CNV (intravitreal injection of any anti-VEGF agent, or any other AMD therapy)

·         Prior intravitreal injection of any anti-VEGF agent or treatment with laser for any indication

·         Choroidal neovascularization from ocular disease other than AMD

·         Dense cataract or other media opacity that would preclude adequate imaging of the macula

 

 

Sample Size

10 participants (participants can have more than one study eye)

Treatment Groups

None

Participant Duration

6 months

Protocol Overview/Synopsis

  1. Informed consent will be obtained for screening.
  2. Eligibility will be assessed and standard care visual acuity will be recorded. Any other visit procedures may be performed at investigator discretion. An OCT taken as part of standard care procedures in the prior 2 weeks may be used for the investigator to confirm eligibility. Data from standard care procedures will be entered on Case Report Forms, and the SD-OCT images obtained as part of standard care will be uploaded to the Coordinating Center.
  3. Eligible eyes will be enrolled and the site will notify Notal Vision Diagnostic Center (NVDC) of the enrolled participant. Site staff will provide the participant with an overview and instructions for using the Home OCT device, including set-up instructions.
  4. NVDC will then ship the Home OCT device system to the participant. The participant will set-up the Home OCT system by themselves or with a family member, friend, or caregiver once delivered to their house (estimated shipping time 3-5 days). Remote support is available by the NVDC via phone.
  5. The first day of follow-up begins with the first successful self-imaging session with the Notal Home OCT on both eyes. Participants will perform daily Home OCT monitoring as part of the study for six months.
  6. NVDC will perform monthly participant engagement calls for the duration of the home monitoring period. The first call will take place two weeks after the first test session.
  7. Notal Vision patient engagement specialist will contact participant if they are not scanning regularly or if images are not of adequate quality. NVDC will reach out on the next business day following two consecutive days of no self-testing. Training will be repeated if images are not of adequate quality.
  8. Follow-up visits will occur at time points the participant is normally seen as part of standard care. All in-person visit procedures are at investigator discretion as part of standard care. Any OCT scans obtained on the study eye(s) will be uploaded to the Coordinating Center. Data on standard care visual acuity, nAMD treatment, and participant experience with the Home OCT system will be captured on Case Report Forms.
  9. At the end of 6 months the participant will return the Home OCT system to Notal using the provided box and shipping label. The participant will complete the study and can continue with their standard care visits outside the study.

 




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