Dropless vs. Standard Drops Contralateral Eye Study

• Status: Completed
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

Summary

To compare the use of an injectable compound containing an antibiotic and an anti-inflammatory at time of cataract surgery to standard of care that is the use 3 different topical medications to prevent inflammation and infection after routine cataract surgery.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Carolina Eyecare Physicians, LLC
• Collaborator: Science in Vision
• Treatments: Fluoroquinolones; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Moxifloxacin; Nepafenac; Norgestimate, ethinyl estradiol drug combination; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Triamcinolone Acetonide

Criteria

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

Exclusion Criteria:

• 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, macular degeneration (with anticipated best postoperative visual acuity less than 20/30), advanced glaucomatous damage, etc.

• Presence of epiretinal membrane.

• Uncontrolled diabetes.

• Use of any systemic or topical drug known to interfere with visual performance.

• Contact lens use during the active treatment portion of the trial.

• Any concurrent infectious/non infectious 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.

• Previous radial keratotomy.

• 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 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.