Anesthetic Impregnated Bandage Soft Contact Lens (BSCL) in Pain Management After Photorefractive Keratectomy (PRK)

Efficacy and Safety of Anesthetic Impregnated Bandage Soft Contact Lens (BSCL) in Pain Management After Photorefractive Keratectomy (PRK).

Compared to laser-assisted in situ keratomileusis (LASIK), Photorefractive Keratectomy (PRK) is associated with more discomfort and requires more downtime. However, it is oftentimes considered the preferred method of refractive surgery for patients with dry eye syndrome, high refractive errors, thin corneas, or those with more active lifestyles who may be more prone to dislodging their LASIK flaps. We hypothesize that the use of bandage contact lenses soaked in proparacaine will decrease pain levels compared to solely the use of bandage contact lenses after PRK.

Study Overview

• Status: Recruiting
• Conditions: Refractive Errors; Astigmatism; Myopia; Hypermetropia
• Intervention / Treatment: Drug: Proparacaine Ophthalmic

Detailed Description

Photorefractive keratectomy (PRK) is a popular method for the correction of refractive errors. Compared to laser-assisted in situ keratomileusis (LASIK), PRK is often associated with more discomfort and requires more downtime. However, it is oftentimes considered the preferred method of refractive surgery for patients with dry eye syndrome, high refractive errors, thin corneas, or those with more active lifestyles who may be more prone to dislodging their LASIK flaps. It can also avoid other complications associated with LASIK including striae, folds, diffuse lamellar keratitis, and epithelial ingrowth. As a result, improved management of post-operative pain in patients undergoing PRK is critical in order encourage utilization and patient preference of this procedure.

The current standard of care for pain management after PRK is the use of a bandage soft contact lens (BSCL). BSCLs may speed reepithelialization and function as an adjunct for pain control.

Using a BSCL soaked in proparacaine has not yet been studied as a pain management method after PRK. Our hypothesis is that combining these two methods will result in greater pain reduction than using a BSCL alone, which is the current standard of care. Furthermore, soaking the BSCL in anesthetics will reduce the chance that patients can abuse anesthetic medication postoperatively, which is the concern when patients are sent home with anesthetic drops as is noted in several prior studies.

This study aims to explore the potential of an anesthetic soaked bandage soft contact lens in reducing pain levels compared to a bandage soft contact lens alone after PRK.

Study Goals:

• To assess the perception of pain following photorefractive keratectomy with the utilization of an anesthetic soaked bandage soft contact lens versus control (BSCL only) using the Visual Analog Pain Scale.
• To assess the effect of an anesthetic soaked bandage soft contact lens on re-epithelialization following photorefractive keratectomy versus control. This will be assessed on post-operative day 5 as whether there is a persistent epithelial defect or not, a binary outcome.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Beeran Meghpara, MD; Phone Number: 2159283180; Email: bmeghpara@willseye.org
• Study Contact Backup: Name: Cherie A Fathy, MD, MPH; Phone Number: 2159283000; Email: cherie.fathy@jefferson.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19123
      • Recruiting
      • Wills Eye Hospital
      • Contact: Beeran Meghpara, MD; Phone Number: 215-928-3180; Email: bmeghpara@willseye.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All eyes approved for photorefractive keratectomy with Dr. Beeran Meghpara or Dr. Christopher Rapuano, with or without the assistance of residents.

Exclusion Criteria:

• Patients undergoing unilateral procedure.
• Eyes that experience complication during the photorefractive keratectomy procedure
• Patients who are pregnant or breast feeding
• Patients under 18 years of age
• Patients with a history of eye surgery or trauma and those with irregular astigmatism, keratoconus, or any other type of corneal disorder, pregnancy, diabetic retinopathy, or glaucoma.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bandage Contact Lens + Proparacaine; The eye that receives a bandage contact lens soaked in proparacaine.	Drug: Proparacaine Ophthalmic; Each subject will have one eye randomized to receive a bandage contact lens soaked in anesthetic solution (proparacaine hydrochloride 0.5%) and the following eye will serve as a control and receive a bandage soft contact lens soaked in balanced salt solution, which is the current standard of care for PRK.; Other Names: Proparacaine; proparacaine hydrochloride 0.5%
No Intervention: Bandage Contact Lens WITHOUT Proparacaine; The eye that receives a bandage contact lens (standard of care).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily pain score at post-operative day 0 through post-operative day 5	Primary Outcome Measure is pain score at post-operative day 0 THROUGH post-operative day 5. Patients will be asked to fill out their score daily. The Wong-Baker Faces pain scale will be used to measure pain. This is a self-report measure of pain consisting of a series of faces with expressions of increasing distress. Each face is also given a numerical rating from 0 to 5, zero representing no pain and 5 representing worst pain.	5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete re-epithelialization at post-operative day 5	A binary outcome (yes/no) of whether the corneal epithelium has completely healed by post-operative day 5.	5 days
Final refractive outcome at postoperative month 3	Snellen visual acuity, both without correction and best corrected with a manifest refraction.	3 Months

Collaborators and Investigators

• Sponsor: Beeran Meghpara, MD
• Investigators: Principal Investigator: Beeran Meghpara, MD, Wills Eye Hospital at TJUH

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: February 16, 2020
• First Submitted That Met QC Criteria: February 20, 2020
• First Posted (Actual): February 25, 2020

Study Record Updates

• Last Update Posted (Actual): October 6, 2021
• Last Update Submitted That Met QC Criteria: October 4, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: refractive surgery; PRK; LASIK
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism; Hyperopia; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Proxymetacaine; Propoxycaine
• Other Study ID Numbers: 19-871

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes