RECRUITING

Optimize Pediatric OCT Imaging

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Handheld optical coherence tomography (OCT) has become an important imaging modality to evaluate the pediatric retina. The objective of this pilot study is to compare a new contact OCT system (Theia Imaging) with an investigational noncontact OCT system (Duke Biomedical Engineering) to assess their ability to image the pediatric retina. The investigators hypothesize that the contact OCT system is superior in imaging larger areas of the retina (larger field-of-view), while it has similar resolution to image the retina substructures (non-inferior image quality).

Official Title

Optimize Pediatric OCT (Optical Coherence Tomography) Imaging: a Pilot Study

Quick Facts

Study Start:2024-01-24
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06139523

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Group 1 - Healthy adult volunteers
  2. * Subject is able and willing to consent to study participation
  3. * Subject is more than 18 years of age
  4. * Healthy adult volunteers without known ocular issues other than refractive error
  5. * Pregnancy Reasonably Excluded Guide (PREG) evaluation on women of childbearing potential
  6. * Group 2 - Pediatric participants
  7. * Health care provider, knowledgeable of protocol, agrees that study personnel could contact the parent/legal guardian
  8. * Parent/legal guardian is able and willing to consent to study participation
  9. * Pediatric patient less than 18 years of age in Duke Eye Center ophthalmology clinics or undergoing clinically-indicated examination under anesthesia at Duke Eye Center
  1. * Group 1 - Healthy adult volunteers
  2. * Students or employees under direct supervision of the investigators
  3. * Subjects with prior problems with pupil dilation
  4. * Pregnant woman if receiving dilating drops
  5. * Group 2 - Pediatric participants
  6. * Parent/legal guardian unwilling or unable to provide consent
  7. * Participant has a health or eye condition that preclude eye examination or retinal imaging (such as corneal opacity or cataract)

Contacts and Locations

Study Contact

Xi Chen, MD
CONTACT
(919)684-8434
xi2.chen@duke.edu
Michelle N McCall, MCAPM, BA
CONTACT
(919) 684-0544
michelle.mccall@duke.edu

Study Locations (Sites)

Duke University Eye Center
Durham, North Carolina, 27710
United States

Collaborators and Investigators

Sponsor: Duke University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-24
Study Completion Date2025-12

Study Record Updates

Study Start Date2024-01-24
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • Optical Coherence Tomography (OCT)

Additional Relevant MeSH Terms

  • Retinal Disease
  • Glaucoma
  • Optic Nerve Diseases