Using Loteprednol to Reduce Pain After Eye Injections
The Role of Loteprednol in Reducing Post-Intravitreal Injection Related Pain
NA · Virginia Polytechnic Institute and State University · NCT05542381
This study is testing if using loteprednol eye drops can help reduce pain after eye injections for people with age-related macular degeneration.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Virginia Polytechnic Institute and State University (other) |
| Locations | 1 site (Roanoke, Virginia) |
| Trial ID | NCT05542381 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of loteprednol, a corticosteroid, in reducing pain following intravitreal injections for patients with age-related macular degeneration. Participants who are already receiving these injections will be randomly assigned to receive either loteprednol drops or artificial tears after their injection. Pain levels will be assessed through follow-up phone calls at 2 hours, 1 day, and 1 week post-injection. The goal is to quantify pain reduction and improve patient care after these procedures.
Who should consider this trial
Good fit: Ideal candidates are adults with age-related macular degeneration who are scheduled to receive intravitreal injections.
Not a fit: Patients with pre-existing chronic pain disorders or those who cannot communicate their pain levels may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new method for managing pain after intravitreal injections, enhancing patient comfort and quality of care.
How similar studies have performed: While corticosteroids like loteprednol are commonly used in ophthalmology, this specific application for pain management after intravitreal injections is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All patients must have age-related macular degeneration and be undergoing intravitreal injections for treatment as defined by a retina specialist. Exclusion Criteria: * Dementia * Report baseline eye pain * Use topical NSAIDs or steroids * Patient under 18 years old * History of corticosteroid responsive elevation in intraocular pressure * Allergy to Loteprednol or Nepafenac * Pre-existing chronic pain disorders * Advanced Glaucoma * Herpes zoster * Allergy to local anesthetic or penicillin * Patients unable to consent on own behalf * Patients unable to communicate pain * Pregnancy * Incarceration
Where this trial is running
Roanoke, Virginia
- Vistar Eye Center — Roanoke, Virginia, United States (RECRUITING)
Study contacts
- Principal investigator: Vishak John, MD — Vistar Eye Center
- Study coordinator: Paul K Varghese
- Email: paulv@vt.edu
- Phone: 7033999886
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.
Conditions: Age-Related Macular Degeneration, Loteprednol, Loteprednol Etabonate Ophthalmic Suspension, Immunosuppressive Agents, Glucocorticoids, Immunologic Factors, Molecular Mechanisms of Pharmacological Action, Eye Diseases