Clinical Trial: Lotoprednol vs. Prednisolone and Fluorometholone

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Efficacy and Safety of Loteprednol 0.5% Gel for Routine Prophylaxis After Photorefractive Keratectomy Compared to Prednisolone Acetate 1% Suspension and Fluorometholone 0.1% Suspension

Brief Summary:

Corneal haze, in which the cornea becomes cloudy, is a well-known and a potentially vision-threatening postoperative complication of PRK. Topical ophthalmic corticosteroids are routinely prescribed by most surgeons postoperatively to help prevent this complication.

Goals of topical steroids use after PRK include effective modulation of the healing response to prevent corneal haze while at the same time minimizing side effects, such as intraocular pressure elevation or cataract formation. Loteprednol etabonate is a corticosteroid that exerts its therapeutic effects and is then quickly changed into inactive metabolites. This relatively fast metabolism of loteprednol gives it a lower side effect profile than other steroids, including a smaller effect on intraocular pressure. In the ophthalmic literature, there is currently no consensus on a standard regimen or which type of corticosteroid should be used after PRK.

Investigators are conducting a prospective, randomized trial to compare the incidence of intraocular pressure rise and visually significant postoperative corneal haze after PRK with the use of loteprednol 0.5% gel compared to the use of earlier generation steroids, prednisolone acetate 1% suspension and fluorometholone 0.1% suspension.


Detailed Summary:
Sponsor: University of Utah

Current Primary Outcome: Change in intraocular pressure from baseline through month 12 [ Time Frame: 12 months ]

Intraocular pressure will be measured by applanation tonometry


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in grade of corneal haze from month 1 through month 12 [ Time Frame: 12 months ]
    Corneal haze will be measured on the Fantes scale
  • Change in manifest refraction from baseline through month 12 [ Time Frame: 12 months ]
    Manifest refraction will be measured
  • Change in best corrected visual acuity from baseline through month 12 [ Time Frame: 12 months ]
    Best corrected visual acuity will be measured
  • Change in uncorrected visual acuity from baseline through month 12 [ Time Frame: 12 months ]
    Best uncorrected visual acuity will be measured


Original Secondary Outcome: Same as current

Information By: University of Utah

Dates:
Date Received: April 17, 2017
Date Started: September 19, 2014
Date Completion: September 2017
Last Updated: April 17, 2017
Last Verified: April 2017