Dropless vs. Standard Drops Contralateral Eye Study

January 29, 2018 updated by: Carolina Eyecare Physicians, LLC

Comparison of Dropless Prophylaxis After Routine Phacoemulsification to Standard Drops Regimen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Key factors for a successful cataract surgery include, among others, preoperative measurements for accurate intraocular lens (IOL) calculation, surgical technique and surgeon's experience but also the use of prophylactic topical antibiotics and anti-inflammatories (steroidal and non-steroidal, NSAID) to decrease the risk of postoperative infection (i.e. endophthalmitis) and intraocular inflammation (i.e. macular edema, CME).

Even though, the large body of literature that supports the significance of prophylactic eye drops prior to surgery, patient compliance is a common problem. Different factors have been associated with patient's lack of compliance. It could be due to patient's inability to self administer the drops, lack of understanding of the importance of using the prophylactic treatment as well as understanding the instructions of how to administer the drops and its storage, or just forgetfulness or the fact that they don't like to put the drops multiple times a day for 2-4 weeks, therefore they just avoid doing it.

There is a new option called "Dropless cataract surgery". This modality of treatment involves the injection of an eye compatible compound at time of cataract surgery.

The purpose of is to assess the efficacy the compound injected during routine cataract surgery and intraocular (IOL) implantation with and without a topical NSAID compared to standard prophylactic treatment that includes the topical use of Moxifloxacin, Ilevro, and Prednisolone acetate 1%.

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Bloomington, Minnesota, United States, 55431
        • Minnesota Eye Consultants, P.A.
      • Stillwater, Minnesota, United States, 55082
        • Associated Eye Care
    • New York
      • Garden City, New York, United States, 11530
        • Ophthalmic Consultants of Long Island
    • South Carolina
      • Mount Pleasant, South Carolina, United States, 29464
        • Carolina Eyecare Physicians, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: TriMoxiVanc
The formulation containing triamcinolone acetonide, moxifloxacin hydrochloride and vancomycin used as an injection at the end of the uneventful phacoemulsification procedure. The compounded Tri-Moxy-Vanco will be delivered into the vitreous cavity using a transzonular approach after IOL implantation before removal of the OVD.
Drug: TriMoxiVanc
triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml to be injected at time of cataract surgery.
Other Names:
  • Dropless
Active Comparator: TriMoxiVanc + Ilevro
Nepafenac ophthalmic suspension 0.3% will be started 3 days prior to surgery QD and continue QD for 4 weeks after surgery. The compounded Tri-Moxy-Vanco will be injected into the vitreous cavity using a transzonular approach after IOL implantation before removal of the OVD.
Drug: TriMoxiVanc
triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml to be injected at time of cataract surgery.
Other Names:
  • Dropless
Drug: Ilevro
NSAID to be used 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery.
Other Names:
  • Nepafenac 0.3%
Active Comparator: Control

Moxifloxacin HCl 0.1%, 1 drop, QID for 3 days prior to surgery and will continue for 2 weeks after surgery and then discontinue.

Nepafenac ophthalmic suspension 0.3% : 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery.

Prednisolone acetate 1% will be started after surgery QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued.
Drug: Ilevro
NSAID to be used 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery.
Other Names:
  • Nepafenac 0.3%
Drug: Moxifloxacin HCl 0.5%
Antibiotic to be used 1 drop, QID for 3 days prior to surgery and will continue for 2 weeks after surgery and then discontinue.
Other Names:
  • Vigamox, Moxeza
Drug: Prednisolone acetate 1%
Steroid to be started after surgery 1 drop QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued.
Other Names:
  • Pred Forte, Econopred Plus, Omnipred

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline (Preoperative Exam) in Macular Thickness
Time Frame: Month 1.
Macula is the area in the retina that is responsible for the best central vision. Changes in its thickness may occur after cataract surgery due to the normal inflammatory process that occurs postoperatively but it returns to preoperative values unless there is an underlying disease.
Month 1.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline (Preoperative Exam) in Pachymetry (Corneal Thickness)
Time Frame: Month 1

Cornea is the clear part of the front of the eye. Normal corneal thickness is in average 0.540 mm. The corneal thickness is measured with a handheld device called pachymeter.

An increase in corneal thickness may indicate corneal edema (swelling of the cornea) that could be seen after ocular surgery.
Month 1
Change From Baseline (Preoperative Exam) in Intraocular Pressure (IOP)
Time Frame: Month 1.
Intraocular pressure refers to the pressure inside the eye. It is measured in mmHg using a device called a tonometer. The mean IOP is 15.5 mmHg. Raised IOP after cataract surgery is common and in most cases it is transient and benign.
Month 1.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carolina Eyecare Physicians, LLC

Collaborators

Science in Vision

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

July 29, 2015

First Submitted That Met QC Criteria

July 31, 2015

First Posted (Estimate)

August 4, 2015

Study Record Updates

Last Update Posted (Actual)

February 23, 2018

Last Update Submitted That Met QC Criteria

January 29, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEP 14-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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