Study of Difluprednate vs. Prednisolone Acetate on Visual Acuity, and Corneal Edema Following Cat… (NCT01244334) | Clinical Trial Compass
CompletedPhase 4
Study of Difluprednate vs. Prednisolone Acetate on Visual Acuity, and Corneal Edema Following Cataract Surgery.
United States52 participantsStarted 2009-03
Plain-language summary
The purpose of this clinical research study is to investigate the efficacy of predosing patients undergoing cataract surgery with the potent corticosteroid difluprednate ophthalmic emulsion 0.05% compared to prednisolone acetate 1% on corneal edema (swelling), and retinal thickness.
Who can participate
Age range21 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Healthy male or female 21 years of age or older
* Scheduled to undergo standard cataract surgery with topical anesthesia in both eyes within 6-25 days between surgeries.
* Willing and able to administer eye drops and record the times the drops were instilled
* Understand and are willing to sign the Informed Consent form
* Willing to complete the entire course of the study.
Exclusion Criteria:
* Use of an eye medication or drops within 48 hours of the scheduled cataract surgery, other than the study medication or procedural solution required for surgery.
* Known sensitivity to any of the ingredients in the study medications or similar medications.
* Scheduled for 2nd eye cataract surgery earlier than 6 days or longer than 25 days apart.
* Corneal edema in either eye.
* Need for regional or general anesthesia during surgery.
* Complicated cataract surgery, including use of iris hooks or iris stretchers.
* Sight better than 20/100 in only one eye.
* A history of previous intraocular surgery in either eye.
* A history of uveitis, iritis, or intraocular inflammation.
* Macular pathology of the retina.
* Presence of glaucoma.
* Any confirmed or suspected active viral, bacterial, or fungal keratoconjunctival disease.
* History of steroid-related intraocular pressure (IOP) rise in the study eye.
* Lack of an intact corneal epithelium.
* Pupils that do not dilate to more than 5 mm prior to surgery or you require mechanical stretching of your pupil.
* Diabetes …
What they're measuring
1
Assess change from Baseline on visual acuity, corneal edema, and retinal thickness at Day 1
Timeframe: Change from Baseline in visual acuity, corneal edema, and retinal thickness at Day 1