A Comparison of 0.5% Loteprednol Etabonate Versus 1% Prednisolone Acetate Following Cataract Surgery

Study Overview
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Brief Summary
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Patients are routinely given steroid eye drops following cataract surgery. This study will compare 2 approved drops:Loteprednol Etabonate versus Prednisolone Acetate Eye drops used following cataract surgery. Patients will be randomly assigned to one drop or the other, and evaluated for inflammation and intraocular pressure as part of the comparison. The study Doctor will be masked as to which drop the patient receives to avoid bias.

Official Title
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A Randomized, Multicenter, Masked Evaluation of 0.5% Loteprednol Etabonate Versus 1% Prednisolone Acetate for the Treatment of Inflammation Following Cataract Surgery

Conditions
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Intraocular Inflammation

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects age 18 and older undergoing routine cataract surgery. Exclusion Criteria: Subjects being treated for elevated intraocular pressure, retinopathy, maculopathy, cornea or vitreous opacities that would interfere with visual acuity. Subjects with diabetes, pseudoexfoliation, uveitis, corneal endothelial disease, or active Herpes Simplex Virus(HSV) or Herpes Zoster Virus(HZV) Pupil Stretch and/or Limbal Relaxing Incision(LRIs) will be allowed. Subjects with previous ocular trauma or intraocular surgery Subjects with sensitivities to steroids. Women who are not post-menopausal or are of child bearing potential will be excluded. Intraoperative complications during surgery including posterior capsule rupture and vitreous loss Subjects with best visual potential in the fellow eye worse than 20/60 Subjects who are expected to require concurrent ocular or systemic therapy with non-steroidal anti-inflammatory drugs (NSAIDS) mast cell stabilizers, antihistamines, or decongestants within 2 days prior to or during the 21 days following surgery. (Intraoperative NSAIDS for mydriasis are permitted.) 325 mg Aspirin is permitted. Subjects who are expected to require concurrent ocular or systemic corticosteroids, immunosuppressants (including Restasis) within 14 days prior to or 21 days following surgery

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects undergoing Cataract Surgery<br>Subjects undergoing routine cataract surgery | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular inflammation grading | Slit Lamp examination will be done at each visit to grade intraocular inflammation | Day 21 Post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular pressure spikes | Intraocular pressure(IOP) will be measured at each visit. | Day 21 post-op | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intraocular Inflammation following routine Cataract Surgery