Age-Related Macular Degeneration
Conditions
Keywords
Loteprednol, Loteprednol Etabonate Ophthalmic Suspension, Immunosuppressive Agents, Glucocorticoids, Immunologic Factors, Molecular Mechanisms of Pharmacological Action, Eye Diseases, Retinal Diseases, Anti-Inflammatory Agents, vascular endothelial growth factor, Intravitreal Injection, Post-Intravitreal Injection Pain
Brief summary
Patients are already receiving an intravitreal injection as a standard of care, but they are consenting to receiving a loteprednol drop following the intravitreal injection. This clinical trial is studying the role of loteprednol (corticosteroid) in reducing pain following intravitreal injections for patients with age-related macular degeneration. As of now, there is no definitive pain management technique following intravitreal injections. Loteprednol is a corticosteroid widely used in ophthalmology to treat pain and inflammation, however, it has not been studied as a treatment for pain following intravitreal injections. Our overall goal is to manage pain to improve quality of care after intravitreal injections. Participants will be given either loteprednol, or artificial tears following one visit for an intravitreal injection to test how effective loteprednol is in pain reduction. Pain levels will be assessed by asking participants over the phone about their pain from a scale of 0 to 10 at three different times over a 1-week period. Artificial tear and medication usage will also be tracked over a 1-week period.
Detailed description
Patients are already receiving an intravitreal injection as a standard of care for age-related macular degeneration, but they are consenting to receiving a loteprednol drop following the intravitreal injection for the research study. Loteprednol is used as a part of regular medical care at the Vistar Eye Center following intravitreal injections but quantifying the magnitude of pain reduction has not been done yet. Additionally, as of now there is no definitive pain management technique following intravitreal injections. This clinical trial is studying the role of loteprednol (corticosteroid) in reducing pain following intravitreal injections for patients with age-related macular degeneration. Participants will be treated with either loteprednol, or artificial tears following one visit for an intravitreal injection at the Vistar Eye Center to test how effective loteprednol is in pain reduction. Pain levels will be assessed by asking participants over the phone about their pain from a scale of 0 to 10 at 2-hours, 1-day, and 1-week following the intravitreal injection. Intravitreal injections will be performed by the retina surgeon, and phone calls will be done with the research coordinator. Artificial tear and medication usage will also be tracked over a 1-week period.
Interventions
DRUGLoteprednol Etabonate Ophthalmic Gel [Lotemax]
Loteprednol (ophthalmic corticosteroid) will be stored in the clinic according to the instructions on the package. The vial will be stored upright between 15°-25°C (59°-77°F). In the clinic, the vial will be opened by the retina surgeon according to sterile procedure and administered (1 drop) by the surgeon immediately after the intravitreal injection.
OTHERRefresh Lubricant Eye Drops [Artificial Tears]
REFRESH® Brand Lubricant Eye Drops are artificial tears. In the clinic, the vial will be opened by the retina surgeon according to sterile procedure and administered (1 drop) by the surgeon immediately after the intravitreal injection.
Sponsors
Vistar Eye Center
Virginia Polytechnic Institute and State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
The study design is a double-blinded placebo-controlled experiment, as the patient and the investigator recording the pain scores will not know which treatment arm the patient is assigned to (negative control or experimental group).
Intervention model description
Double-blinded placebo-controlled design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-Intravitreal Injection Pain | 2-hour Post-Intravitreal Injection | 11-point Numerical Rating Scale (0-10, 0 being the lowest level of pain and 10 being highest level of pain) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Analgesic Medication Use | 2-hour Post-Intravitreal Injection | Pill count |
| Artificial Tear Use | 2-hour Post-Intravitreal Injection | Artificial Tear Drop Count |
Countries
United States
Outcome results
None listed