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| Name | Class |
|---|---|
| Science in Vision | OTHER |
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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.
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%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TriMoxiVanc | Active Comparator | 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. |
|
| TriMoxiVanc + Ilevro | Active Comparator | 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. |
|
| Control | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TriMoxiVanc | Drug | triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml to be injected at time of cataract surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Month 1. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Month 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kerry D Solomon, MD | Carolina Eyecare Physicians, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minnesota Eye Consultants, P.A. | Bloomington | Minnesota | 55431 | United States | ||
| Associated Eye Care |
No significant events in the study occurred after participant enrollment, but prior to randomization.
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.
| ID | Title | Description |
|---|---|---|
| FG000 | 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. TriMoxiVanc: triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml to be injected at time of cataract surgery. |
| FG001 | 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. TriMoxiVanc: triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml to be injected at time of cataract surgery. Ilevro: NSAID to be used 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery. |
| FG002 | 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. 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. Ilevro: NSAID to be used 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery. Prednisolone acetate 1%: Steroid to be started after surgery 1 drop QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | Microns | Month 1. |
|
In average, adverse event data was collected for 6 weeks from the time the Informed consent was signed until patient exited the study.
Adverse events were classified as related to study treatment or not related. All reported adverse events were considered not related to study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. TriMoxiVanc: triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml to be injected at time of cataract surgery. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry eyes | Eye disorders |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Helga P. Sandoval, MD, MSCR. Director of Research | Carolina Eyecare Physicians, LLC | 8438813937 | helga.sandoval@carolinaeyecare.com |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000077266 | Moxifloxacin |
| C414203 | nepafenac |
| C009935 | prednisolone acetate |
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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|
| Moxifloxacin HCl 0.5% | Drug | Antibiotic to be used 1 drop, QID for 3 days prior to surgery and will continue for 2 weeks after surgery and then discontinue. |
|
|
| Ilevro | Drug | NSAID to be used 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery. |
|
|
| Prednisolone acetate 1% | Drug | Steroid to be started after surgery 1 drop QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued. |
|
|
| 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. | Month 1. |
| Stillwater |
| Minnesota |
| 55082 |
| United States |
| Ophthalmic Consultants of Long Island | Garden City | New York | 11530 | United States |
| Carolina Eyecare Physicians, LLC | Mt. Pleasant | South Carolina | 29464 | United States |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. TriMoxiVanc: triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml to be injected at time of cataract surgery. Ilevro: NSAID to be used 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery. |
| OG002 | 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. 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. Ilevro: NSAID to be used 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery. Prednisolone acetate 1%: Steroid to be started after surgery 1 drop QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued. |
|
|
| 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. | Posted | Mean | Standard Deviation | Microns | Month 1 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | mmHg | Month 1. |
|
|
|
| 0 |
| 29 |
| 3 |
| 29 |
| EG001 | 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. TriMoxiVanc: triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml to be injected at time of cataract surgery. Ilevro: NSAID to be used 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery. | 0 | 26 | 1 | 26 |
| EG002 | 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. 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. Ilevro: NSAID to be used 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery. Prednisolone acetate 1%: Steroid to be started after surgery 1 drop QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued. | 0 | 55 | 5 | 55 |
| Rebound inflammation | Eye disorders |
|
| Allergic conjuctivitis | Eye disorders |
|
| Posterior vitreous detachments | Eye disorders |
|
| Retinal detachment | Eye disorders |
|
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| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |