Cataract
Conditions
Keywords
Cataract, Surgery, Prophylaxis
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%.
Interventions
Steroid to be started after surgery 1 drop QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued.
DRUGTriMoxiVanc
triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml to be injected at time of cataract surgery.
DRUGMoxifloxacin 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.
DRUGIlevro
NSAID to be used 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery.
Sponsors
Science in Vision
Carolina Eyecare Physicians, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline (Preoperative Exam) in Macular Thickness | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline (Preoperative Exam) in Pachymetry (Corneal Thickness) | 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) | 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. |
Countries
United States
Participant flow
Recruitment details
Study recruitment started on December 2014 and ended in March 2016. Potential subjects were identified from the patients presenting at the clinics for eye evaluation.
Pre-assignment details
No significant events in the study occurred after participant enrollment, but prior to randomization.
Participants by arm
| Arm | Count |
|---|---|
| TriMoxiVanc One Eye + Control Fellow Eye Subject's eyes were randomized to either TriMoxiVan or Control group.
TriMoxiVanc group:
Triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml used as an injection delivered into the vitreous cavity using a transzonular approach at the end of the uneventful phacoemulsification procedure after IOL implantation before removal of the OVD.
Control group:
Moxifloxacin HCl 0.5%: 1 drop, QID for 3 days prior to surgery and continued for 2 weeks after surgery and then discontinued.
Ilevro (Nepafenac ophthalmic suspension 0.3%): 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery.
Prednisolone acetate 1%: Started after surgery 1 drop QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued. | 29 |
| TriMoxiVanc + Ilevro One Eye + Control Fellow Eye Subject's eyes were randomized to either TriMoxiVan + Ilevro or Control group.
TriMoxiVan + Ilevro group:
Nepafenac ophthalmic suspension 0.3% started 3 days prior to surgery QD and continued QD for 4 weeks after surgery. The compounded Tri-Moxy-Vanco (triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml ) injected into the vitreous cavity using a transzonular approach after IOL implantation before removal of the OVD.
Control group:
Moxifloxacin HCl 0.5%: 1 drop, QID for 3 days prior to surgery and continued for 2 weeks after surgery and then discontinued.
Ilevro (Nepafenac ophthalmic suspension 0.3%): 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery.
Prednisolone acetate 1%: Started after surgery 1 drop QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued. | 30 |
| Total | 59 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 3 | 3 |
| Overall Study | Lost to Follow-up | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | TriMoxiVanc One Eye + Control Fellow Eye | TriMoxiVanc + Ilevro One Eye + Control Fellow Eye | Total |
|---|---|---|---|
| Age, Continuous | 67.9 Years STANDARD_DEVIATION 7.5 | 69.3 Years STANDARD_DEVIATION 6.8 | 68.5 Years STANDARD_DEVIATION 7.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants | 30 Participants | 59 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 29 participants | 30 participants | 59 participants |
| Sex: Female, Male Female | 21 Participants | 18 Participants | 39 Participants |
| Sex: Female, Male Male | 8 Participants | 12 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 3 / 29 | 1 / 26 | 5 / 55 |
| serious Total, serious adverse events | 0 / 29 | 0 / 26 | 0 / 55 |
Outcome results
Primary
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.
Time frame: Month 1.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TriMoxiVanc | Change From Baseline (Preoperative Exam) in Macular Thickness | 12.34 Microns | Standard Deviation 13.05 |
| TriMoxiVanc + Ilevro | Change From Baseline (Preoperative Exam) in Macular Thickness | 10.96 Microns | Standard Deviation 11.55 |
| Control | Change From Baseline (Preoperative Exam) in Macular Thickness | 9.84 Microns | Standard Deviation 15.84 |
Secondary
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.
Time frame: Month 1.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TriMoxiVanc | Change From Baseline (Preoperative Exam) in Intraocular Pressure (IOP) | -0.5 mmHg | Standard Deviation 2.8 |
| TriMoxiVanc + Ilevro | Change From Baseline (Preoperative Exam) in Intraocular Pressure (IOP) | -1.03 mmHg | Standard Deviation 3.3 |
| Control | Change From Baseline (Preoperative Exam) in Intraocular Pressure (IOP) | -1.1 mmHg | Standard Deviation 3 |
Secondary
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.
Time frame: Month 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TriMoxiVanc | Change From Baseline (Preoperative Exam) in Pachymetry (Corneal Thickness) | 14.44 Microns | Standard Deviation 13.95 |
| TriMoxiVanc + Ilevro | Change From Baseline (Preoperative Exam) in Pachymetry (Corneal Thickness) | 5.94 Microns | Standard Deviation 14.07 |
| Control | Change From Baseline (Preoperative Exam) in Pachymetry (Corneal Thickness) | 4.47 Microns | Standard Deviation 15.63 |