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Completed

NCT Number: NCT05542381

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

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.

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Key information

Conditions

Age-Related Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vistar Eye Center

Roanoke, Virginia, 24019, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Loteprednol Etabonate Ophthalmic Gel [Lotemax]

Drug

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 Lubricant Eye Drops [Artificial Tears]

Other

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.

Other names: Refresh

Primary outcomes

  1. Post-Intravitreal Injection Pain

    Time frame: 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)

  2. Post-Intravitreal Injection Pain

    Time frame: 1-day Post-Intravitreal Injection

    11-point Numerical Rating Scale (0-10, 0 being the lowest level of pain and 10 being highest level of pain)

  3. Post-Intravitreal Injection Pain

    Time frame: 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 outcomes

  1. Analgesic Medication Use

    Time frame: 2-hour Post-Intravitreal Injection

    Pill count

  2. Analgesic Medication Use

    Time frame: 1-day Post-Intravitreal Injection

    Pill count

  3. Analgesic Medication Use

    Time frame: 1-week Post-Intravitreal Injection

    Pill count

  4. Artificial Tear Use

    Time frame: 2-hour Post-Intravitreal Injection

    Artificial Tear Drop Count

  5. Artificial Tear Use

    Time frame: 1-day Post-Intravitreal Injection

    Artificial Tear Drop Count

  6. Artificial Tear Use

    Time frame: 1-week Post-Intravitreal Injection

    Artificial Tear Drop Count

Sponsors and collaborators

Lead sponsor

Virginia Polytechnic Institute and State University

Other

Collaborators

  • Vistar Eye Center

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Sep 15, 2022
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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