Using advanced imaging technology during eye surgery
Intraoperative OCT Guidance of Intraocular Surger
This study is testing a new imaging technology during eye surgery to see if it can help doctors perform better and improve outcomes for patients with retinal diseases.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 262 (estimated) |
| Ages | 4 Weeks and up |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT03713268 on ClinicalTrials.gov |
What this trial studies
This project aims to develop and implement microscope integrated optical coherence tomography (MIOCT) to provide real-time volumetric imaging during intraocular surgeries. By enhancing surgical visualization, the technology seeks to improve outcomes for patients undergoing procedures for various retinal diseases, including macular holes and diabetic retinopathy. The study will involve both healthy controls and patients requiring vitreoretinal or anterior segment surgeries, allowing for a comprehensive evaluation of the technology's effectiveness. The goal is to overcome current limitations in surgical practice and enable new microsurgical techniques.
Who should consider this trial
Good fit: Ideal candidates include adults and children undergoing vitreoretinal or anterior segment surgeries for conditions like macular holes, epiretinal membranes, and glaucoma.
Not a fit: Patients with ocular diseases that prevent effective OCT scanning may not benefit from this study.
Why it matters
Potential benefit: If successful, this technology could significantly enhance surgical precision and outcomes for patients with complex retinal conditions.
How similar studies have performed: Other studies utilizing advanced imaging techniques in surgery have shown promising results, indicating potential for success with this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Durham, North Carolina
- Duke University Eye Center — Durham, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Cynthia A Toth, MD — Duke University
- Study coordinator: Neeru Sarin, MBBS
- Email: neeru.sarin@duke.edu
- Phone: 919-668-5341
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.