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

NCT04283331 | Unknown Phase 4 FDA Drug

• 1 other identifier: 19-871
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia; Hypermetropia; Refractive Errors; Astigmatism

Keywords

refractive surgery; PRK; LASIK

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Complete re-epithelialization at post-operative day 5

  5 days

• Final refractive outcome at postoperative month 3

  3 Months

Study Arms (2)

Bandage Contact Lens + Proparacaine

EXPERIMENTAL

The eye that receives a bandage contact lens soaked in proparacaine.

Drug: Proparacaine Ophthalmic

Bandage Contact Lens WITHOUT Proparacaine

NO INTERVENTION

The eye that receives a bandage contact lens (standard of care).

Interventions

Proparacaine Ophthalmic DRUG

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.

Also known as: Proparacaine, proparacaine hydrochloride 0.5%

Bandage Contact Lens + Proparacaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beeran Meghpara, MD: lead

Study Sites (1)

Wills Eye Hospital

Philadelphia, Pennsylvania, 19123, United States

RECRUITING

MeSH Terms

Conditions

Myopia; Hyperopia; Refractive Errors; Astigmatism

Interventions

proxymetacaine

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Beeran Meghpara, MD

  Wills Eye Hospital at TJUH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Beeran Meghpara, MD

CONTACT

2159283180; bmeghpara@willseye.org

Cherie A Fathy, MD, MPH

CONTACT

2159283000; cherie.fathy@jefferson.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The laser vision technician will be the only member aware of which eye received the control vs intervention treatment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Assistant Professor of Ophthalmology

Study Record Dates

• First Submitted: February 16, 2020
• First Posted: February 25, 2020
• Study Start: June 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: October 6, 2021

Record last verified: 2021-10

Locations

US (1)