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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
64
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.
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.
Vistar Eye Center
Roanoke, Virginia, United States
Post-Intravitreal Injection Pain
11-point Numerical Rating Scale (0-10, 0 being the lowest level of pain and 10 being highest level of pain)
Time frame: 2-hour Post-Intravitreal Injection
Post-Intravitreal Injection Pain
11-point Numerical Rating Scale (0-10, 0 being the lowest level of pain and 10 being highest level of pain)
Time frame: 1-day Post-Intravitreal Injection
Post-Intravitreal Injection Pain
11-point Numerical Rating Scale (0-10, 0 being the lowest level of pain and 10 being highest level of pain)
Time frame: 1-week Post-Intravitreal Injection
Analgesic Medication Use
Pill count
Time frame: 2-hour Post-Intravitreal Injection
Analgesic Medication Use
Pill count
Time frame: 1-day Post-Intravitreal Injection
Analgesic Medication Use
Pill count
Time frame: 1-week Post-Intravitreal Injection
Artificial Tear Use
Artificial Tear Drop Count
Time frame: 2-hour Post-Intravitreal Injection
Artificial Tear Use
Artificial Tear Drop Count
Time frame: 1-day Post-Intravitreal Injection
Artificial Tear Use
Artificial Tear Drop Count
Time frame: 1-week Post-Intravitreal Injection
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