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

Study Overview
=================
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.

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

Conditions
-----------------
Age-Related Macular Degeneration

Intervention / Treatment
-----------------
* Drug: Loteprednol Etabonate Ophthalmic Gel [Lotemax]
* Other: Refresh Lubricant Eye Drops [Artificial Tears]


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double-blinded placebo-controlled design
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Loteprednol<br>1 drop of Loteprednol is administered immediately after the intravitreal injection in this treatment arm. | Drug: Loteprednol Etabonate Ophthalmic Gel [Lotemax]<br>* 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.<br>|
| Placebo Comparator: Artificial tears<br>1 drop of artificial tears is administered immediately after the intravitreal injection in this treatment arm. This arm acts as a negative control. | Other: Refresh Lubricant Eye Drops [Artificial Tears]<br>* 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.<br>* Other names: Refresh;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | 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) | 1-week Post-Intravitreal Injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesic Medication Use | Pill count | 2-hour Post-Intravitreal Injection | 
| Analgesic Medication Use | Pill count | 1-day Post-Intravitreal Injection | 
| Analgesic Medication Use | Pill count | 1-week Post-Intravitreal Injection | 
| Artificial Tear Use | Artificial Tear Drop Count | 2-hour Post-Intravitreal Injection | 
| Artificial Tear Use | Artificial Tear Drop Count | 1-day Post-Intravitreal Injection | 
| Artificial Tear Use | Artificial Tear Drop Count | 1-week Post-Intravitreal Injection | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
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