The Role of Loteprednol in Reducing Post-Intravitreal Injection Related Pain

Not Applicable

Recruiting

• Conditions: Age-Related Macular Degeneration
• Interventions: Drug: Loteprednol Etabonate Ophthalmic Gel [Lotemax]; Other: Refresh Lubricant Eye Drops [Artificial Tears]

• Registration Number: NCT05542381
• Lead Sponsor: Virginia Polytechnic Institute and State University

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.

Study Timeline

• Study First Submitted: 2022-09-01
• Study First Submitted QC: 2022-09-14
• Study First Posted: 2022-09-15
• Study Start: 2022-12-22
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-18
• Last Update Posted: 2024-01-22
• Primary Completion: 2024-09-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• All patients must have age-related macular degeneration and be undergoing intravitreal injections for treatment as defined by a retina specialist.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Loteprednol	Loteprednol Etabonate Ophthalmic Gel [Lotemax]	1 drop of Loteprednol is administered immediately after the intravitreal injection in this treatment arm.
Artificial tears	Refresh Lubricant Eye Drops [Artificial Tears]	1 drop of artificial tears is administered immediately after the intravitreal injection in this treatment arm. This arm acts as a negative control.

Primary Outcome Measures

Name	Time	Method
Post-Intravitreal Injection Pain	1-week 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 Outcome Measures

Name	Time	Method
Analgesic Medication Use	1-week Post-Intravitreal Injection	Pill count
Artificial Tear Use	1-week Post-Intravitreal Injection	Artificial Tear Drop Count

Trial Locations

Locations (1)

Vistar Eye Center; 🇺🇸 Roanoke, Virginia, United States