Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Dropless vs. Standard Drops Contralateral Eye Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02515045
Recruitment Status : Completed
First Posted : August 4, 2015
Results First Posted : August 22, 2017
Last Update Posted : February 23, 2018
Sponsor:
Collaborator:
Science in Vision
Information provided by (Responsible Party):
Carolina Eyecare Physicians, LLC

Tracking Information
First Submitted Date  ICMJE July 29, 2015
First Posted Date  ICMJE August 4, 2015
Results First Submitted Date  ICMJE July 24, 2017
Results First Posted Date  ICMJE August 22, 2017
Last Update Posted Date February 23, 2018
Study Start Date  ICMJE January 2015
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 29, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 31, 2015)
Change From Baseline (Preoperative Exam) in Macular Thickness [ Time Frame: Baseline, week 2 and month 1. ]
Change History Complete list of historical versions of study NCT02515045 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2018)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dropless vs. Standard Drops Contralateral Eye Study
Official Title  ICMJE Comparison of Dropless Prophylaxis After Routine Phacoemulsification to Standard Drops Regimen
Brief 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Cataract
Intervention  ICMJE
  • 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 Name: Dropless
  • 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 Name: Vigamox, Moxeza
  • Drug: Ilevro
    NSAID to be used 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery.
    Other Name: Nepafenac 0.3%
  • 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 Name: Pred Forte, Econopred Plus, Omnipred
Study Arms  ICMJE
  • 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.
    Intervention: Drug: TriMoxiVanc
  • 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.
    Interventions:
    • Drug: TriMoxiVanc
    • Drug: Ilevro
  • 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.

    Interventions:
    • Drug: Moxifloxacin HCl 0.5%
    • Drug: Ilevro
    • Drug: Prednisolone acetate 1%
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 25, 2016)
59
Original Estimated Enrollment  ICMJE
 (submitted: July 31, 2015)
66
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02515045
Other Study ID Numbers  ICMJE CEP 14-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Carolina Eyecare Physicians, LLC
Study Sponsor  ICMJE Carolina Eyecare Physicians, LLC
Collaborators  ICMJE Science in Vision
Investigators  ICMJE
Principal Investigator: Kerry D Solomon, MD Carolina Eyecare Physicians, LLC
PRS Account Carolina Eyecare Physicians, LLC
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP