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NCT Number: NCT03713268

Intraoperative OCT Guidance of Intraocular Surgery II

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.

Recruiting

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Key information

Conditions

Macular Holes Cardiovascular Diseases Cataract Cranial Nerve Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Retinopathy Endocrine System Diseases Epiretinal Membrane Eye Diseases Eye Neoplasms Healthy Lens Diseases Neoplasms Neoplasms by Site Nervous System Diseases Ocular Motility Disorders Ocular Tumor Preretinal Fibrosis Retinal Detachment Retinal Disease Retinal Diseases Retinal Perforations Strabismus Vascular Diseases

Age range

4 week and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University Eye Center

Durham, North Carolina, 27710, United States

Location status: Recruiting

Location contact

Anthony Kuo, MD

PRINCIPAL_INVESTIGATOR

Cynthia A Toth, MD

PRINCIPAL_INVESTIGATOR

Michelle McCall

CONTACT

[email protected]

919-684-0544

Neeru Sarin

CONTACT

[email protected]

9196685641

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Other names: MIOCT

Primary outcomes

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

    Time frame: Year 1

    Ability to capture images

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

    Time frame: Year 1

    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.

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

    Time frame: Year 1

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

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

    Time frame: Year 1

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

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

    Time frame: Year 1

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

  6. 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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Michelle N McCall, MCAPM, BA

CONTACT

[email protected]

919-684-0554

Neeru Sarin, MBBS

CONTACT

[email protected]

919-668-5341

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Eye Institute (NEI)

Registry information

Official study title

Intraoperative OCT Guidance of Intraocular Surger

Acronym: MIOCT

Important dates

Study start
2018
Primary completion
2026
Study completion
2027
First posted
Oct 19, 2018
Registry last updated
Oct 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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