Recruiting

BSCL

Sponsor:

Beeran Meghpara, MD

Code:

NCT04283331

Conditions

Myopia

Hypermetropia

Refractive Errors

Astigmatism

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Proparacaine Ophthalmic

Study Details

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

Study ID

NCT04283331

Start date

Jun 1, 2020

Status verified date

Oct, 2021

Completion date

Dec 31, 2021

Anticipated

Primary completion date

Dec 31, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Bandage Contact Lens + Proparacaine

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

no intervention: Bandage Contact Lens WITHOUT Proparacaine

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

Interventions

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.

Primary outcome measure

  • Daily pain score at post-operative day 0 through post-operative day 5 [ Time Frame: 5 days ]

Central Contacts and Locations

Central contacts

Beeran Meghpara, MD

2159283180bmeghpara@willseye.org

Cherie A Fathy, MD, MPH

2159283000cherie.fathy@jefferson.edu

Locations

Wills Eye Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19123

Contacts

Beeran Meghpara, MD

215-928-3180bmeghpara@willseye.org

More Information

Sponsor

Beeran Meghpara, MD

Last update posted

Oct 6, 2021

Last verified

Oct, 2021

Keywords

  • refractive surgery; PRK; LASIK

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Beeran Meghpara, MD on 2021-10-06.