Clinical trial NCT03713268: Intraoperative OCT Guidance of Intraocular Surgery II
Official title: Intraoperative OCT Guidance of Intraocular Surger
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Macular Holes
Epiretinal Membrane
Diabetic Retinopathy
Retinal Detachment
Retinal Disease
Preretinal Fibrosis
Cataract
Ocular Tumor
Strabismus
Healthy
Keywords: Microscope Integrated optical coherence tomography
MIOCT
OCT Angiography
OCTA
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Eye Institute (NEI)
First posted: 2018-10-19
Enrollment: 262
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 262 subjects enrolled in 3 groups as follows:

1. Healthy Controls: 50 subjects
2. Surgeons as research subjects performing randomized testing in wet lab: 22 subjects
3. Surgical patients as research subjects for application to ocular vitreoretinal and anterior segment surgery: 190 subjects

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Retinal and/or corneal microscope integrated optical coherence tomography image capture
timeFrame: Year 1
measure: Quality of retinal and/or corneal microscope integrated optical coherence tomography image capture
timeFrame: Year 1
measure: Retinal vascular flow on optical coherence tomography angiography (OCTA) versus fluorescein angiography
timeFrame: Year 1
measure: Assessment of change in pattern of ocular vascular flow before and after standard clinical surgical steps.
timeFrame: Year 1
measure: Assessment of change in ocular morphology before and after standard surgical steps
timeFrame: Year 1
measure: Estimate of subretinal fluid volume before and after surgery for retinal detachment based on surgical view versus based on OCT output
timeFrame: Year 1
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Eye Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Cynthia A Toth, MD
role: PRINCIPAL_INVESTIGATOR
References: