Efficacy and safety of loteprednol 0.5% gel for routine prophylaxis after photorefractive keratectomy compared to prednisolone acetate 1% suspension and fluoromethalone 0.1% suspension

Principal Investigator: Mark Mifflin
Keywords: refractive surgery , PRK Department: Ophthalmology-Services
IRB Number: 00075978 Co Investigator:  
Specialty: Ophthalmology, Ophthalmology
Sub Specialties: Refractive Surgery,
Recruitment Status: Recruiting

Contact Information

Mark Mifflin

Brief Summary

Hypothesis: Loteprednol 0.5% gel will perform similarly or better than a regimen of prednisolone acetate 1% and fluorometholone 0.1% in the prevention of visually significant postoperative corneal haze after photorefractive keratectomy (PRK) with a lower incidence of intraocular pressure elevation.

Objectives: We aim to conduct 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. Patients undergoing PRK will be assigned to 1 of 2 postoperative steroid regimens. Group 1 will use only loteprednol 0.5% gel, tapered off slowly based on clinical evaluations of the corneal healing response.  Group 2 will use prednisolone acetate 1% suspension tapered down to a regimen of fluorometholone 0.1% which will then be tapered off based on clinical evaluations of the corneal healing response.  If no difference in efficacy or safety is detected between these two regimens, this study will support the use of either steroid regimen in patients after PRK. If there is a major difference in the efficacy or safety of these two regimens, this could influence post-refractive surgery treatment practices.

Inclusion Criteria

All subjects who are deemed suitable candidates for PRK after routine refractive surgery screening will be considered eligible for participation in this study.  Subjects must be at least 21 years of age and not pregnant or nursing (due to fluctuations in visual parameters during pregnancy).

Exclusion Criteria

Selection will be consistent with the current standard of care for PRK.  Any patient that is not a suitable candidate for PRK will not be included.