NCT04283331

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).

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Beeran Meghpara, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Myopia
• Hypermetropia
• Refractive Errors
• Astigmatism

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-06-01
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2020-02-25
• Last updated: 2021-10-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study