Recruiting

OCT Guidance

Sponsor:

Duke University

Code:

NCT03713268

Conditions

Macular Holes

Epiretinal Membrane

Diabetic Retinopathy

Retinal Detachment

Retinal Disease

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

Microscope integrated optical coherence tomography

Study Details

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

Study ID

NCT03713268

Start date

Sep 30, 2018

Status verified date

Oct, 2025

Completion date

May 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

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 Design

Enrollment

262 participants

Anticipated

Interventions and Outcome Measures

Arms

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).

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.

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.

Interventions

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.

Primary outcome measure

  • Retinal and/or corneal microscope integrated optical coherence tomography image capture [ Time Frame: Year 1 ]
  • Quality of retinal and/or corneal microscope integrated optical coherence tomography image capture [ Time Frame: Year 1 ]
  • Retinal vascular flow on optical coherence tomography angiography (OCTA) versus fluorescein angiography [ Time Frame: Year 1 ]
  • Assessment of change in pattern of ocular vascular flow before and after standard clinical surgical steps. [ Time Frame: Year 1 ]
  • Assessment of change in ocular morphology before and after standard surgical steps [ Time Frame: Year 1 ]
  • Estimate of subretinal fluid volume before and after surgery for retinal detachment based on surgical view versus based on OCT output [ Time Frame: Year 1 ]

Central Contacts and Locations

Central contacts

Neeru Sarin, MBBS

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

Michelle N McCall, MCAPM, BA

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

Locations

Duke University Eye Center

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Michelle McCall

919-684-0544mccal023@mc.duke.edu

Neeru Sarin

9196685641neeru.sarin@duke.edu

Principal Investigator:

Cynthia A Toth, MD

More Information

Sponsor

Duke University

Last update posted

Oct 6, 2025

Last verified

Oct, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-03. This information was provided to ClinicalTrials.gov by Duke University on 2025-10-06. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.