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Dropless vs. Standard Drops Contralateral Eye Study

Primary Purpose

Cataract

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
TriMoxiVanc
Moxifloxacin HCl 0.5%
Ilevro
Prednisolone acetate 1%
Sponsored by
Carolina Eyecare Physicians, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cataract focused on measuring Cataract, Surgery, Prophylaxis

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Minnesota Eye Consultants, P.A.
  • Associated Eye Care
  • Ophthalmic Consultants of Long Island
  • Carolina Eyecare Physicians, LLC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

TriMoxiVanc

TriMoxiVanc + Ilevro

Control

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Change From Baseline (Preoperative Exam) in Macular Thickness
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.

Secondary Outcome Measures

Change From Baseline (Preoperative Exam) in Pachymetry (Corneal Thickness)
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)
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.

Full Information

First Posted
July 29, 2015
Last Updated
January 29, 2018
Sponsor
Carolina Eyecare Physicians, LLC
Collaborators
Science in Vision
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1. Study Identification

Unique Protocol Identification Number
NCT02515045
Brief Title
Dropless vs. Standard Drops Contralateral Eye Study
Official Title
Comparison of Dropless Prophylaxis After Routine Phacoemulsification to Standard Drops Regimen
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Carolina Eyecare Physicians, LLC
Collaborators
Science in Vision

4. Oversight

Data Monitoring Committee
No

5. Study Description

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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Cataract, Surgery, Prophylaxis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TriMoxiVanc
Arm Type
Active Comparator
Arm Description
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.
Arm Title
TriMoxiVanc + Ilevro
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
TriMoxiVanc
Other Intervention Name(s)
Dropless
Intervention Description
triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml to be injected at time of cataract surgery.
Intervention Type
Drug
Intervention Name(s)
Moxifloxacin HCl 0.5%
Other Intervention Name(s)
Vigamox, Moxeza
Intervention Description
Antibiotic to be used 1 drop, QID for 3 days prior to surgery and will continue for 2 weeks after surgery and then discontinue.
Intervention Type
Drug
Intervention Name(s)
Ilevro
Other Intervention Name(s)
Nepafenac 0.3%
Intervention Description
NSAID to be used 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery.
Intervention Type
Drug
Intervention Name(s)
Prednisolone acetate 1%
Other Intervention Name(s)
Pred Forte, Econopred Plus, Omnipred
Intervention Description
Steroid to be started after surgery 1 drop QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued.
Primary Outcome Measure Information:
Title
Change From Baseline (Preoperative Exam) in Macular Thickness
Description
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.
Time Frame
Month 1.
Secondary Outcome Measure Information:
Title
Change From Baseline (Preoperative Exam) in Pachymetry (Corneal Thickness)
Description
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.
Time Frame
Month 1
Title
Change From Baseline (Preoperative Exam) in Intraocular Pressure (IOP)
Description
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.
Time Frame
Month 1.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kerry D Solomon, MD
Organizational Affiliation
Carolina Eyecare Physicians, LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Minnesota Eye Consultants, P.A.
City
Bloomington
State/Province
Minnesota
ZIP/Postal Code
55431
Country
United States
Facility Name
Associated Eye Care
City
Stillwater
State/Province
Minnesota
ZIP/Postal Code
55082
Country
United States
Facility Name
Ophthalmic Consultants of Long Island
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Facility Name
Carolina Eyecare Physicians, LLC
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States

12. IPD Sharing Statement

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Dropless vs. Standard Drops Contralateral Eye Study

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