Carolina Eyecare Physicians, LLC is holding a study on preventing inflammation and infection after cataract surgery using antibiotic, a non-steroidal and steroidal anti-inflammatory eyedrops. This intervention is studied when compared to standard care of 3 different topical medications. Typically, prophylactic topical antibiotics and anti-inflammatory medications are used to prevent postoperative and intraocular inflammation.
There is an estimated enrollment of 35 participants. Changes in macular Thickness, pachymetry (corneal thickness), and intraocular Pressure (IOP) are measured in preoperative exam and 1 month after surgery. LessDrops, a Pred-Gati-Brom formulation, are compared with gatifloxacin, bromfenac and prednisolone acetate 1%.
All sexes, ages 50 to 90 year old, are allowed to participate. Other inclusion criteria:
- Subject is undergoing bilateral cataract extraction or refractive lens exchange with intraocular lens implantation.
- Willing and able to provide written informed consent for participation in the study.
- Willing and able to comply with scheduled visits and other study procedures.
- Willing and able to administer eye drops and record the times the drops were instilled.
- Scheduled to undergo standard cataract surgery with topical anesthesia in both eyes within 6-15 days between surgeries.
- Potential postoperative best-corrected visual acuity of 20/30 or better.
Those not allowed to participate have or use:
- Severe preoperative ocular pathology: amblyopia, rubella cataract, proliferative diabetic retinopathy, shallow anterior chamber, macular edema, aniridia or iris atrophy, uveitis, history of iritis, iris neovascularization, medically uncontrolled glaucoma, microphthalmos or macrophthalmos, optic nerve atrophy, advanced macular degeneration, advanced glaucomatous damage, etc.
- Uncontrolled diabetes.
- Use of any systemic or topical drugs known to interfere with visual performance.
- Contact lens use during the active treatment portion of the trial.
- Any concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis.
- History of chronic intraocular inflammation.
- History of retinal detachment.
- Pseudoexfoliation syndrome or any other condition that has the potential to weaken the zonules.
- Any additional ocular surgical procedures at time of cataract extraction (i.e. iStent) except corneal incisions for the correction of astigmatism.
- Anesthesia other than topical anesthesia (i.e. retrobulbar, general, etc).
- Any clinically significant, serious or severe medical or psychiatric condition that may increase the risk associated with study participation or may interfere with the interpretation of study results.
- Participation in (or current participation) any ophthalmic investigational drug or device trial within the previous 30 days prior to the start date of this trial.
- Intraocular conventional surgery within the past three months or intraocular laser surgery within one month.
Those interested may participate in this study at Carolina Eyecare Physicians, LLC in Mount Pleasant, South Carolina, 29464. Feel free to contact Kerry D Solomon, MD at 843-881-3937 or at email@example.com.
This clinical trial is sponsored by Carolina Eyecare Physicians, LLC and collaborated by Science in Vision and Imprimis Pharmaceuticals, Inc. The principal investigator is Kerry D Solomon, MD and the sub-investigator is Jefrrey F Hood, OD
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