Intraoperative OCT Guidance of Intraocular Surgery II

NCT03713268 | Recruiting FDA Device

• 2 other identifiers: Pro00100437U01EY028079
• Study Type: observational
• Target: 262
• Locations: 1 country
• Sites: 1

Brief Summary

The overall five-year goals of the project are to develop novel technology to provide actionable new information through provision of live volumetric imaging during surgery, improving surgical practice and outcomes. The investigators believe this technology will enable novel ophthalmic and other microsurgeries not possible due to current limitations in surgical visualization.

Conditions

Macular Holes; Epiretinal Membrane; Diabetic Retinopathy; Retinal Detachment; Retinal Disease; Preretinal Fibrosis; Cataract; Ocular Tumor; Strabismus; Healthy

Keywords

Microscope Integrated optical coherence tomography; MIOCT; OCT Angiography; OCTA

Outcome Measures

Primary Outcomes (6)

• Retinal and/or corneal microscope integrated optical coherence tomography image capture

  Ability to capture images

  Year 1

• Quality of retinal and/or corneal microscope integrated optical coherence tomography image capture

  Quality of MIOCT images scored based on standard microanatomy and ability to detect presence or absence of ocular pathologies based on review by a masked grader.

  Year 1

• Retinal vascular flow on optical coherence tomography angiography (OCTA) versus fluorescein angiography

  Cross correlation of ability to capture vessels and vessel pathology between OCTA and fluorescein angiographic images.

  Year 1

• Assessment of change in pattern of ocular vascular flow before and after standard clinical surgical steps.

  Presence or absence of change in ocular morphology in pattern of vascular flow compared to prior to surgical steps

  Year 1

• Assessment of change in ocular morphology before and after standard surgical steps

  Presence or absence of change in ocular morphology before and after standard surgical steps

  Year 1

• Estimate of subretinal fluid volume before and after surgery for retinal detachment based on surgical view versus based on OCT output

  Volume estimates from surgeons analyzed relative to the postoperative calculated volume from the intraoperative MIOCT

  Year 1

Study Arms (3)

Healthy (ocular health) participants

Adult subjects with normal, ocular health will be enrolled to evaluate and obtain multiple images from the microscope integrated optical coherence tomography system for reproducibility testing in humans, provide feedback to engineers, and verify that the system functions to produce high quality images of the desired areas of the eye after ex vivo development before surgical use. Each healthy subject will be imaged by the MIOCT system. There will be no surgery or intervention on these healthy volunteer subjects. We anticipate that a portion of the volunteer subjects would have repeat imaging (e.g. for reproducibility testing).

Device: Microscope integrated optical coherence tomography

Surgeons as research subjects

Duke Eye Center surgical trainees (residents and fellows), attending surgeons, and surgeons from other medical institutions will be enrolled as subjects as we will test their performance with and without microscope integrated optical coherence tomography and with and without advances in 4D MIOCT in model surgeries in the research wet lab to better understand the utility of specific aspects and of this next generation MIOCT as a whole for specific anterior segment and retinal surgical tasks.

Device: Microscope integrated optical coherence tomography

Surgical patients

Adult and minor (\> 4 months of age) surgical patients will be enrolled to evaluate and obtain multiple images from the microscope integrated optical coherence tomography system during clinically indicated vitreoretinal and anterior segment surgical procedures.

Device: Microscope integrated optical coherence tomography

Interventions

Microscope integrated optical coherence tomography DEVICE

This is translational study in which subjects will either be imaged with a microscope integrated optical coherence tomography (MIOCT) system or they will use MIOCT during surgical procedures. OCT systems are optical imaging technology that allow non-contact imaging of the microanatomy of the retina, cornea, optic nerve head and retinal blood vessels. The MIOCT has been integrated into the surgical microscope used in retinal and anterior segment surgeries so it does not touch the eye. Unlike visible light from many examination devices, the infrared OCT beam is barely visible to the human eye as it sweeps across the retina. Thus the patient is not disturbed by the light.

Also known as: MIOCT

Healthy (ocular health) participants; Surgeons as research subjects; Surgical patients

Eligibility Criteria

• Age: 4 Weeks+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

262 subjects enrolled in 3 groups as follows: 1. Healthy Controls: 50 subjects 2. Surgeons as research subjects performing randomized testing in wet lab: 22 subjects 3. Surgical patients as research subjects for application to ocular vitreoretinal and anterior segment surgery: 190 subjects

You may qualify if:

• Healthy controls: Healthy eyes without known disease: refractive error including myopia and non-significant cataract is allowed. For selected testing pseudophakia is allowed.
• Surgeons as research subjects: Adult (≥18 years old)
• Surgical patients (vitreoretinal surgery): Patients undergoing examination under anesthesia or surgery for vitreoretinal diseases
• Surgical patients (anterior segment surgery-glaucoma, ocular surface or strabismus requiring extraocular muscle surgery): Include both adults and children. Patient undergoing primary, elective minimally invasive glaucoma surgery, ocular surface surgery, or strabismus surgery.

You may not qualify if:

• Healthy controls: Any ocular disease that restricts the ability to perform OCT scanning. Conflict of interest with investigators/study personnel, e.g. a student in the lab of an investigator.
• Surgical patients (vitreoretinal surgery): Neonates (\< 4 weeks of age) and patients with any ocular disease that restricts the ability to perform OCT scanning.
• Surgical patients (anterior segment surgery-corneal and cataract diseases): Pediatric patients: The cornea and cataract surgery studies will be restricted to adults (≥ 18 years). Children do not have cataract surgery typically by residents and therefore would not fit our study design. Similarly pediatric corneal transplants are very rare.

Sponsors & Collaborators

• Duke University: lead
• National Eye Institute (NEI): collaborator

Study Sites (1)

Duke University Eye Center

Durham, North Carolina, 27710, United States

RECRUITING

MeSH Terms

Conditions

Retinal Perforations; Epiretinal Membrane; Diabetic Retinopathy; Retinal Detachment; Retinal Diseases; Cataract; Eye Neoplasms; Strabismus

Condition Hierarchy (Ancestors)

Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Lens Diseases; Neoplasms by Site; Neoplasms; Ocular Motility Disorders; Cranial Nerve Diseases; Nervous System Diseases

Study Officials

• Cynthia A Toth, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Neeru Sarin, MBBS

CONTACT

919-668-5341; neeru.sarin@duke.edu

Michelle N McCall, MCAPM, BA

CONTACT

919-684-0554; michelle.mccall@duke.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2018
• First Posted: October 19, 2018
• Study Start: September 30, 2018
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): May 31, 2027
• Last Updated: October 6, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)