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NCT03713268 | RECRUITING | Macular Holes

Intraoperative OCT Guidance of Intraocular Surgery II
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.

Condition or disease

Macular Holes

Epiretinal Membrane

Diabetic Retinopathy

Retinal Detachment

Retinal Disease

Preretinal Fibrosis

Cataract

Ocular Tumor

Strabismus

Healthy

Intervention/treatment

Microscope integrated optical coherence tomography

Study Type : OBSERVATIONAL
Estimated Enrollment : 262 participants
Official Title : Intraoperative OCT Guidance of Intraocular Surger
Actual Study Start Date : 2018-09-30
Estimated Primary Completion Date : 2025-12-31
Estimated Study Completion Date : 2026-05-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 4 Weeks
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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.
Intraoperative OCT Guidance of Intraocular Surgery II

Location Details

NCT03713268

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How to Participate

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Locations

RECRUITING

United States, North Carolina

Duke University Eye Center

Durham, North Carolina, United States, 27710