# A High-Speed, User-Friendly, Handheld OCT System for Patients who are Unable to Cooperate

> **NIH NIH R44** · THEIA IMAGING LLC · 2024 · $938,909

## Abstract

ABSTRACT
 Optical coherence tomography (OCT) is the gold standard for the diagnosis and monitoring of retinal and
optic nerve diseases. Clinical OCT systems (large tabletop devices with chinrest) require a compliant subject,
and thus are not suitable for use with infants, young children, and patients who are unable to cooperate for eye
imaging (such as from physical disability or while under anesthesia or in intensive care). As many of these
patients cannot communicate about vision disturbance or vision loss, diagnosis of disease is difficult to achieve
before irrevocable vision loss occurs. One example of this population is preterm infants in intensive care and
who are at risk for retinopathy of prematurity (ROP). While handheld OCT (HH-OCT) has led to significant
insights into the development of ROP, its use for disease screening has been limited in part due to poor
usability of the existing commercial systems due to weight, ergonomics and speed of imaging. The need for
image-based classification of ROP was a subject of the recent International Classification of ROP Committee.
There is a clear need for a commercial, point of care, high-speed, user-friendly handheld OCT system to
improve the standard of care for infants, young children, and patients who are unable to cooperate for imaging.
 Theia Imaging is pursuing commercialization of the Theia 2 high-speed, portable, user-friendly, hand-held
OCT system for use in these patients. Our long-term objective is to enable clinicians and researchers to gather
much-needed OCT imaging of the retina and/or optic nerve head in their patients. This will decrease the need
for examinations under anesthesia and simplify access to valuable information about the retina and optic nerve
head at the time of eye care and general health care.
 This Phase II effort will build on the Theia 1 system developed in the Phase I, to result in an FDA-
submission for a handheld system that is lightweight, with a small, ergonomic handpiece and imaging at high
speed and a robust commercialization pathway. Theia Imaging will achieve this through the following Aims:
Aim 1: Refine the T1 Prototype into a Commercial Medical Device. We will refine both the design of the probe
and OCT engine allowing us to scale to production quantities and reduce the overall cost of the device. Aim 2:
Refine the T1 Software into a Commercial Product. We will refine this software under a software quality
assurance system and improve usability. Aim 3: Pilot Study, Pivotal Study and 510(k) Submission. With the
refined Theia 2 system, we will execute pilot and pivotal human studies in support of a 510(k) submission The
expected outcome of this proposal is the development of a commercially viable, 300 kHz HH-OCT system and
a 510(k) submission for FDA clearance of the device. Both the device and associated software will be
designed to be usable by ophthalmic technicians without the need for specialized training.

## Key facts

- **NIH application ID:** 10849762
- **Project number:** 5R44EY032394-03
- **Recipient organization:** THEIA IMAGING LLC
- **Principal Investigator:** Al-Hafeez Zahir Dhalla
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $938,909
- **Award type:** 5
- **Project period:** 2021-06-01 → 2025-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10849762

## Citation

> US National Institutes of Health, RePORTER application 10849762, A High-Speed, User-Friendly, Handheld OCT System for Patients who are Unable to Cooperate (5R44EY032394-03). Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/grant/nih/10849762. Licensed CC0.

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