Macular HolesMIOCTNCT03713268
Intraoperative OCT Guidance of Intraocular Surgery II
An observational study of Macular Holes and Epiretinal Membrane, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 weeks and olderHealthy volunteers can take part
- Conditions the study is for
- Macular Holes, Epiretinal Membrane, Diabetic Retinopathy
- What is being tested?
- Microscope integrated optical coherence tomography
- Type of treatment
- Medical device
- How many people
- 262 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2018to 31 May 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 weeks and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
- Surgeons as research subjects: no specific exclusion criteria.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke University Eye Center
Durham, North Carolina, 27710
Michelle McCall, 9196840544, mccal023@mc.duke.edu
Neeru Sarin, 9196685641, neeru.sarin@duke.edu
About this study
Official title: 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.
- Conditions
- Macular Holes, Epiretinal Membrane, Diabetic Retinopathy, Retinal Detachment, Retinal Disease, Preretinal Fibrosis
- Being tested
- Microscope integrated optical coherence tomography
- Keywords
- Microscope Integrated optical coherence tomography, MIOCT, OCT Angiography, OCTA
- Medical subject headings
- Retinal Perforations, Epiretinal Membrane, Diabetic Retinopathy, Retinal Detachment, Retinal Diseases, Cataract, Eye Neoplasms, Strabismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microscope integrated optical coherence tomographyDevice
Also called MIOCT
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: 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. Receives: Device: Microscope integrated optical coherence tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal and/or corneal microscope integrated optical coherence tomography image capture
Ability to capture images
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: Year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start30 Sep 2018
- Primary completion31 Dec 2026 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular HolesStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 262 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Sponsor
- Investigators
- Cynthia A Toth, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03713268
- Sponsor's protocol ID
- Pro00100437
- Other IDs
- U01EY028079
- Acronym
- MIOCT
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2018
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No