Lotoprednol vs. Prednisolone and Fluorometholone
| Status: | Completed |
|---|---|
| Conditions: | Ocular, Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 11/1/2018 |
| Start Date: | September 19, 2014 |
| End Date: | July 2018 |
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
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.
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.
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.
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