Point-of-Care Ophthalmic Diagnostic Imaging of Retinopathy of Prematurity

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT06612541
Status
Recruiting

Conditions

  • ROP Examination
  • Retinopathy of Prematurity (ROP)

Eligibility Criteria

Sex
ALL
Age
24 Weeks - 34 Weeks
Healthy Volunteers
Not accepted

Study Details

The goal of this proposal is to develop novel HH-SECTR technology for visualizing and quantifying diagnostic disease features in prematurely born infant retinopathy of prematurity (ROP) patients that lead to more informed clinical decision making. Providing depth-resolved vascular information has not been adequately investigated for its diagnostic potential. Furthermore, we seek to identify disease features not currently accessible by standard examination methods to better inform clinical decisions.

Key Dates

Start date
Feb 1, 2025
Status verified
May 2025
Primary completion
Feb 28, 2029
Completion
Feb 28, 2030

Study Design

Enrollment
90 participants (estimated)

Primary Outcome Measure

Retinal imaging in pediatric ROP patients [ Time Frame: Weekly imaging until 45 weeks, cessation of ROP screening, or first therapeutic intervention, whichever comes first ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt University Medical CenterNashvilleTennessee37232
Marybeth Carter
615-936-1639
Irina De la Huerta, MD PhD (PRINCIPAL_INVESTIGATOR)

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