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

NCT04283331 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-10-06

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Beeran Meghpara, MD

    lead OTHER

Principal Investigators

  • Beeran Meghpara, MD · Wills Eye Hospital at TJUH

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2021-12-31
Completion
2021-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04283331 on ClinicalTrials.gov