RecruitingNot Applicable

Intraoperative OCT Guidance of Intraocular Surgery II

United States262 participantsStarted 2018-09-30

Plain-language 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.

Who can participate

Age range4 Weeks

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

Timeframe: Year 1

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

Timeframe: Year 1

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

Timeframe: Year 1

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

Timeframe: Year 1

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

Timeframe: Year 1

Estimate of subretinal fluid volume before and after surgery for retinal detachment based on surgical view versus based on OCT output

Timeframe: Year 1

Trial details

NCT IDNCT03713268

SponsorDuke University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-12-31

Contact for this trial

Neeru Sarin, MBBS

919-668-5341 neeru.sarin@duke.edu

View on ClinicalTrials.gov More Macular Holes trials

Plain-language summary

Who can participate

Age range4 Weeks

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

Timeframe: Year 1

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

Timeframe: Year 1

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

Timeframe: Year 1

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

Timeframe: Year 1

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

Timeframe: Year 1

Estimate of subretinal fluid volume before and after surgery for retinal detachment based on surgical view versus based on OCT output

Timeframe: Year 1