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Optimize Pediatric OCT Imaging

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
No age limits stated
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares two handheld OCT devices that take pictures of the retina, the light-sensing layer at the back of the eye. One device touches the eye, and the other does not. The study includes healthy adults and children to see if the contact device captures a wider area with similar picture quality.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Adults must be older than 18.
  • Adults must be able and willing to agree to join the study.
  • Adults must have no known eye problems except focusing problems, such as needing glasses.
  • Women who could become pregnant must have a check to rule out pregnancy.
  • Children must be younger than 18.
  • Children must be patients at Duke Eye Center eye clinics or have a medically needed eye exam under anesthesia there. Anesthesia is medicine that makes them sleep during the exam.
  • A health care provider who knows the study must agree that the study team may contact the child's parent or legal guardian.
  • The child's parent or legal guardian must be able and willing to give permission.

Who can't join

  • Adults who are students or employees directly supervised by the study researchers.
  • Adults who have had problems with pupil dilation, which widens the dark center of the eye.
  • Pregnant women who would receive drops to widen their pupils.
  • Children whose parent or legal guardian cannot or will not give permission.
  • Children with a health or eye problem that prevents an eye exam or retina pictures, such as clouding of the eye's clear front surface or lens.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Group 1 - Healthy adult volunteers * Subject is able and willing to consent to study participation * Subject is more than 18 years of age * Healthy adult volunteers without known ocular issues other than refractive error * Pregnancy Reasonably Excluded Guide (PREG) evaluation on women of childbearing potential * Group 2 - Pediatric participants * Health care provider, knowledgeable of protocol, agrees that study personnel could contact the parent/legal guardian * Parent/legal guardian is able and willing to consent to study participation * 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 Exclusion Criteria: * Group 1 - Healthy adult volunteers * Students or employees under direct supervision of the investigators * Subjects with prior problems with pupil dilation * Pregnant woman if receiving dilating drops * Group 2 - Pediatric participants * Parent/legal guardian unwilling or unable to provide consent * Participant has a health or eye condition that preclude eye examination or retinal imaging (such as corneal opacity or cataract)

Study sites (1)

NC