Intraoperative OCT Guidance of Intraocular Surgery II

Recruiting

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

• Registration Number: NCT03713268
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-30
• Study First Submitted: 2018-10-15
• Study First Submitted QC: 2018-10-17
• Study First Posted: 2018-10-19
• Status Verified: 2024-05
• Last Update Submitted: 2024-06-26
• Last Update Posted: 2024-06-27
• Primary Completion: 2024-12-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 262

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy (ocular health) participants	Microscope integrated optical coherence tomography	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	Microscope integrated optical coherence tomography	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	Microscope integrated optical coherence tomography	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.

Primary Outcome Measures

Name	Time	Method
Quality of retinal and/or corneal microscope integrated optical coherence tomography image capture	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.
Retinal vascular flow on optical coherence tomography angiography (OCTA) versus fluorescein angiography	Year 1	Cross correlation of ability to capture vessels and vessel pathology between OCTA and fluorescein angiographic images.
Retinal and/or corneal microscope integrated optical coherence tomography image capture	Year 1	Ability to capture images
Assessment of change in pattern of ocular vascular flow before and after standard clinical surgical steps.	Year 1	Presence or absence of change in ocular morphology in pattern of vascular flow compared to prior to surgical steps
Assessment of change in ocular morphology before and after standard surgical steps	Year 1	Presence or absence of change in ocular morphology before and after standard surgical steps
Estimate of subretinal fluid volume before and after surgery for retinal detachment based on surgical view versus based on OCT output	Year 1	Volume estimates from surgeons analyzed relative to the postoperative calculated volume from the intraoperative MIOCT

Trial Locations

Locations (1)

Duke University Eye Center; 🇺🇸 Durham, North Carolina, United States