Intraoperative OCT Guidance of Intraocular Surgery II (MIOCT)

Intraoperative OCT Guidance of Intraocular Surger

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy; Diabetic Retinopathy; Cataract; Strabismus; Retinal Detachment; Epiretinal Membrane; Macular Holes; Retinal Disease; Preretinal Fibrosis; Ocular Tumor
• Intervention / Treatment: Device: Microscope integrated optical coherence tomography

• Study Type: Observational
• Enrollment (Estimated): 262

Contacts and Locations

• Study Contact: Name: Neeru Sarin, MBBS; Phone Number: 919-668-5341; Email: neeru.sarin@duke.edu
• Study Contact Backup: Name: Michelle N McCall, MCAPM, BA; Phone Number: 919-684-0554; Email: michelle.mccall@duke.edu

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke University Eye Center
      • Contact: Michelle McCall; Phone Number: 919-684-0544; Email: mccal023@mc.duke.edu
      • Contact: Neeru Sarin; Phone Number: 9196685641; Email: neeru.sarin@duke.edu
      • Principal Investigator: Cynthia A Toth, MD
      • Principal Investigator: Anthony Kuo, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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

Description

Inclusion Criteria:

1. Healthy controls: Healthy eyes without known disease: refractive error including myopia and non-significant cataract is allowed. For selected testing pseudophakia is allowed.
2. Surgeons as research subjects: Adult (≥18 years old)
3. Surgical patients (vitreoretinal surgery): Patients undergoing examination under anesthesia or surgery for vitreoretinal diseases
4. 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.

Exclusion Criteria:

1. 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.
2. Surgeons as research subjects: no specific exclusion criteria.
3. Surgical patients (vitreoretinal surgery): Neonates (< 4 weeks of age) and patients with any ocular disease that restricts the ability to perform OCT scanning.
4. 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.; Other Names: MIOCT
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; 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.; Other Names: MIOCT
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; 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.; Other Names: MIOCT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Eye Institute (NEI)
• Investigators: Principal Investigator: Cynthia A Toth, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2018
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): May 31, 2024

Study Registration Dates

• First Submitted: October 15, 2018
• First Submitted That Met QC Criteria: October 17, 2018
• First Posted (Actual): October 19, 2018

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 29, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: OCTA; Microscope Integrated optical coherence tomography; MIOCT; OCT Angiography
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Eye Diseases; Endocrine System Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Lens Diseases; Cranial Nerve Diseases; Ocular Motility Disorders; Retinal Diseases; Diabetic Retinopathy; Cataract; Strabismus; Retinal Perforations; Retinal Detachment; Epiretinal Membrane
• Other Study ID Numbers: Pro00100437; U01EY028079 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No