Anesthetic Impregnated Bandage Soft Contact Lens (BSCL) in Pain Management After Photorefractive Keratectomy (PRK)
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|ClinicalTrials.gov Identifier: NCT04283331|
Recruitment Status : Recruiting
First Posted : February 25, 2020
Last Update Posted : October 19, 2020
|Condition or disease||Intervention/treatment||Phase|
|Myopia Hypermetropia Refractive Errors Astigmatism||Drug: Proparacaine Ophthalmic||Phase 4|
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.
- 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 (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||The laser vision technician will be the only member aware of which eye received the control vs intervention treatment.|
|Primary Purpose:||Supportive Care|
|Official Title:||Efficacy and Safety of Anesthetic Impregnated Bandage Soft Contact Lens (BSCL) in Pain Management After Photorefractive Keratectomy (PRK).|
|Actual Study Start Date :||June 1, 2020|
|Estimated Primary Completion Date :||February 2021|
|Estimated Study Completion Date :||February 2021|
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.
No Intervention: Bandage Contact Lens WITHOUT Proparacaine
The eye that receives a bandage contact lens (standard of care).
- Daily pain score at post-operative day 0 through post-operative day 5 [ Time Frame: 5 days ]
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.
- Complete re-epithelialization at post-operative day 5 [ Time Frame: 5 days ]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 [ Time Frame: 3 Months ]Snellen visual acuity, both without correction and best corrected with a manifest refraction.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04283331
|Contact: Beeran Meghpara, MDfirstname.lastname@example.org|
|Contact: Cherie A Fathy, MD, MPHemail@example.com|
|United States, Pennsylvania|
|Wills Eye Hospital||Recruiting|
|Philadelphia, Pennsylvania, United States, 19123|
|Contact: Beeran Meghpara, MD 215-928-3180 firstname.lastname@example.org|
|Principal Investigator:||Beeran Meghpara, MD||Wills Eye Hospital at TJUH|