Comparing numbing eye drops using a standard bottle and a Nanodropper
Evaluation of Nanodropper-mediated Microdrops vs. Standard Drops of 0.5% Proparacaine HCl
This study tests if a new device called the Nanodropper, which gives smaller eye drops, works as well as regular eye drop bottles for numbing the eyes with a local anesthetic.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 41 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Columbia University Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06636708 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a new device called the Nanodropper, which delivers smaller eye drops, in comparison to traditional eye drop bottles for administering proparacaine, a topical anesthetic. Participants will receive numbing drops in both eyes—one with the standard dropper and the other with the Nanodropper—and their eye sensation will be tested at various intervals to assess numbness. The study seeks to determine if the Nanodropper can provide effective anesthesia while using less medication, potentially reducing costs and waste. Participants will also provide feedback on their experience during the procedure.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who can provide informed consent and verbally communicate their pain responses.
Not a fit: Patients with contraindications to local anesthetics or those with certain ocular conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more efficient use of topical anesthetics, benefiting patients by minimizing medication use and associated costs.
How similar studies have performed: While the use of microdrops is a relatively novel approach, similar studies have shown promise in improving the delivery and effectiveness of topical medications.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Ability to provide informed consent for topical anesthesia delivery 2. Ability to verbally respond to pain 3. At least 18 years of age Exclusion Criteria: 1. Have a contraindication to local anesthetics 2. History of intravitreal injections 3. History of ocular surgery 4. History of vitreous or retinal surgery 5. Preexisting diagnosis of ocular surface disease requiring punctal plug placement 6. Evidence of any current ocular inflammation 7. Any previous ocular condition (i.e., neurotrophic keratitis, herpetic eye disease, presence of a corneal graft, etc.) that has permanently altered the native sensation of the ocular surface 8. Use of contact lenses in the past year 9. Use of exclusionary medications: Topical steroid drops, non-steroidal anti-inflammatory drops, intraocular pressure lowering eye drops, any anti-viral medications used for herpes, opioids
Where this trial is running
New York, New York
- Columbia University Irving Medical Center — New York, New York, United States (Recruiting)
Study contacts
- Study coordinator: Aakriti G Shukla, MD MSc
- Email: ag2965@cumc.columbia.edu
- Phone: 212-305-9535
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.