Clinical trial NCT05542381: The Role of Loteprednol in Reducing Post-Intravitreal Injection Related Pain
Official title: The Role of Loteprednol in Reducing Post-Intravitreal Injection Related Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Age-Related Macular Degeneration
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
Lead sponsor: Virginia Polytechnic Institute and State University
Sponsor class: OTHER
Collaborators: name: Vistar Eye Center
First posted: 2022-09-15
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blinded placebo-controlled design
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Post-Intravitreal Injection Pain
timeFrame: 2-hour Post-Intravitreal Injection
measure: Post-Intravitreal Injection Pain
timeFrame: 1-day Post-Intravitreal Injection
measure: Post-Intravitreal Injection Pain
timeFrame: 1-week Post-Intravitreal Injection
Secondary outcomes:
measure: Analgesic Medication Use
timeFrame: 2-hour Post-Intravitreal Injection
measure: Analgesic Medication Use
timeFrame: 1-day Post-Intravitreal Injection
measure: Analgesic Medication Use
timeFrame: 1-week Post-Intravitreal Injection
measure: Artificial Tear Use
timeFrame: 2-hour Post-Intravitreal Injection
measure: Artificial Tear Use
timeFrame: 1-day Post-Intravitreal Injection
measure: Artificial Tear Use
timeFrame: 1-week Post-Intravitreal Injection
Other outcomes:
Locations:
city: Roanoke
country: United States
facility: Vistar Eye Center
state: Virginia
Study officials:
affiliation: Vistar Eye Center
name: Vishak John, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vistar Eye Center
name: Romulo Albuquerque, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
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