Intraoperative OCT Guidance of Intraocular Surgery II

Healthy Clinical Trial

— MIOCT  

Official title:

Intraoperative OCT Guidance of Intraocular Surger

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03713268
• Other study ID #: Pro00100437
• Secondary ID: U01EY028079
• Status: Recruiting
• Start date: September 30, 2018
• Est. completion date: May 31, 2025

Study information

• Verified date: May 2024
• Source: Duke University
• Contact: Neeru Sarin, MBBS
• Phone: 919-668-5341
• Email: neeru.sarin[@]duke.edu
• Is FDA regulated: No
• Study type: Observational

Clinical 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. The investigators believe this technology will enable novel ophthalmic and other microsurgeries not possible due to current limitations in surgical visualization.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 262
• Est. completion date: May 31, 2025
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Weeks and older

Eligibility

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.

Related Conditions & MeSH terms

• Cataract
• Diabetic Retinopathy
• Epiretinal Membrane
• Healthy
• Macular Holes
• Ocular Tumor
• Preretinal Fibrosis
• Retinal Detachment
• Retinal Disease
• Retinal Diseases
• Retinal Perforations
• Strabismus

Intervention

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 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.

Locations

Country	Name	City	State
United States	Duke University Eye Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Eye Institute (NEI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retinal and/or corneal microscope integrated optical coherence tomography image capture	Ability to capture images	Year 1
Primary	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.	Year 1
Primary	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.	Year 1
Primary	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	Year 1
Primary	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	Year 1
Primary	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	Year 1