NCT03713268 Intraoperative OCT Guidance of Intraocular Surgery II
| NCT ID | NCT03713268 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Duke University |
| Condition | Macular Holes |
| Study Type | OBSERVATIONAL |
| Enrollment | 262 participants |
| Start Date | 2018-09-30 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 262 participants in total. It began in 2018-09-30 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Cynthia A Toth, MD
PRINCIPAL INVESTIGATOR
Duke University
Frequently Asked Questions
Who can join the NCT03713268 clinical trial?
This trial is open to participants of all sexes, aged 4 Weeks or older, studying Macular Holes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03713268 currently recruiting?
Yes, NCT03713268 is actively recruiting participants. Contact the research team at neeru.sarin@duke.edu for enrollment information.
Where is the NCT03713268 trial being conducted?
This trial is being conducted at Durham, United States.
Who is sponsoring the NCT03713268 clinical trial?
NCT03713268 is sponsored by Duke University. The principal investigator is Cynthia A Toth, MD at Duke University. The trial plans to enroll 262 participants.