Newsletter

Stay up to date on all things eye disease. Sign up and we’ll send you the latest news, resources, scientific breakthroughs, events, tips, and much more.

Prophylactic Treatment: Lessdrops vs Standard Drops Regimen

January 17, 2020

Overview

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.

 

Study Information

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%.

 

Inclusion Criteria

 

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.

 

Exclusion Criteria

 

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.

 

Location

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 helga.sandoval@carolinaeyecare.com

 

Sponsors/Collaborators

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

Clinical Trials

View All Clinical Trials

Study of Dark Adaptation in Age-Related Macular Degeneration

In this clinical trial, investigators are trying to see how effective dark adaptation protocol is in identifying…

Eyelash Prostheses vs. Lifitegrast BID for Dry Eye Disease

In this study, investigators are looking at the safety and efficacy of eyelash prostheses compared to 5.0%…

OCT Biomarkers for Diabetic Retinopathy

In this study, investigators are seeing if standard optical coherence tomography (OCT) might be useful for…

Senofilcon A Lenses in Moderate to Severe Dry Eye Disease

In this clinical trial, investigators are studying how Senofilcon A daily contact lenses affect the treatment of…

Visual Function Tests in Age-Related Macular Degeneration

This study is looking to assess visual function tests in people with non-exudative age-related macular degeneration…

Trifocal Intraocular Lens Aberrometry Outcomes

Weill Medical College of Cornell University is holding a clinical trial on trifocal intraocular lens (IOL)…

Binocular Vision Anomalies After Cataract and Refractive Surgery

Salus University is holding a study on binocular vision disorders after cataract and corneal refractive surgery.…

No Drop Post-Op Cataract Surgery

Wake Forest University Health Sciences is holding a clinical trial on infusions of Phenylephrine/Ketorolac during…

Make a comment and share this article on your profile.

Write a comment for your publication

Successfully Shared!

View on my Profile

Send this to a friend