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Recruiting NCT03713268

Intraoperative OCT Guidance of Intraocular Surgery II

— Observational Macular Holes Epiretinal Membrane Diabetic Retinopathy Retinal Detachment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Microscope integrated optical coherence tomography.
Who it may be relevant to
Registry conditions: Macular Holes, Epiretinal Membrane, Diabetic Retinopathy, Retinal Detachment. Basic parameters: from 4 Weeks · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Intraoperative OCT Guidance of Intraocular Surger

Overview

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.

Interventions

  • 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 visi

Primary outcome measures

  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Duke University Eye Center — Durham

Identifiers

NCT: NCT03713268 · Pro00100437 · U01EY028079

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗