Anesthetic Impregnated Bandage Soft Contact Lens (BSCL) in Pain Management After Photorefractive Keratectomy (PRK)
Primary Purpose
Myopia, Hypermetropia, Refractive Errors
Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Proparacaine Ophthalmic
Sponsored by
About this trial
This is an interventional supportive care trial for Myopia focused on measuring refractive surgery; PRK; LASIK
Eligibility Criteria
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.
Sites / Locations
- Wills Eye HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Bandage Contact Lens + Proparacaine
Bandage Contact Lens WITHOUT Proparacaine
Arm Description
The eye that receives a bandage contact lens soaked in proparacaine.
The eye that receives a bandage contact lens (standard of care).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Final refractive outcome at postoperative month 3
Snellen visual acuity, both without correction and best corrected with a manifest refraction.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04283331
Brief Title
Anesthetic Impregnated Bandage Soft Contact Lens (BSCL) in Pain Management After Photorefractive Keratectomy (PRK)
Official Title
Efficacy and Safety of Anesthetic Impregnated Bandage Soft Contact Lens (BSCL) in Pain Management After Photorefractive Keratectomy (PRK).
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Beeran Meghpara, MD
4. Oversight
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
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Hypermetropia, Refractive Errors, Astigmatism
Keywords
refractive surgery; PRK; LASIK
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The laser vision technician will be the only member aware of which eye received the control vs intervention treatment.
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bandage Contact Lens + Proparacaine
Arm Type
Experimental
Arm Description
The eye that receives a bandage contact lens soaked in proparacaine.
Arm Title
Bandage Contact Lens WITHOUT Proparacaine
Arm Type
No Intervention
Arm Description
The eye that receives a bandage contact lens (standard of care).
Intervention Type
Drug
Intervention Name(s)
Proparacaine Ophthalmic
Other Intervention Name(s)
Proparacaine, proparacaine hydrochloride 0.5%
Intervention Description
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.
Primary Outcome Measure Information:
Title
Daily pain score at post-operative day 0 through post-operative day 5
Description
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.
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Complete re-epithelialization at post-operative day 5
Description
A binary outcome (yes/no) of whether the corneal epithelium has completely healed by post-operative day 5.
Time Frame
5 days
Title
Final refractive outcome at postoperative month 3
Description
Snellen visual acuity, both without correction and best corrected with a manifest refraction.
Time Frame
3 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Beeran Meghpara, MD
Phone
2159283180
Email
bmeghpara@willseye.org
First Name & Middle Initial & Last Name or Official Title & Degree
Cherie A Fathy, MD, MPH
Phone
2159283000
Email
cherie.fathy@jefferson.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beeran Meghpara, MD
Organizational Affiliation
Wills Eye Hospital at TJUH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wills Eye Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19123
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beeran Meghpara, MD
Phone
215-928-3180
Email
bmeghpara@willseye.org
12. IPD Sharing Statement
Learn more about this trial
Anesthetic Impregnated Bandage Soft Contact Lens (BSCL) in Pain Management After Photorefractive Keratectomy (PRK)
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