Dropless vs. Standard Drops Contralateral Eye Study
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| ClinicalTrials.gov Identifier: NCT02515045 |
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Recruitment Status :
Completed
First Posted : August 4, 2015
Results First Posted : August 22, 2017
Last Update Posted : February 23, 2018
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cataract | Drug: TriMoxiVanc Drug: Moxifloxacin HCl 0.5% Drug: Ilevro Drug: Prednisolone acetate 1% | Phase 4 |
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 (Clinical Trial) |
| Actual Enrollment : | 59 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | Comparison of Dropless Prophylaxis After Routine Phacoemulsification to Standard Drops Regimen |
| Study Start Date : | January 2015 |
| Actual Primary Completion Date : | March 2016 |
| Actual Study Completion Date : | March 2016 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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 |
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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.
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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: 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% |
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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: 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 |
- 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.
- 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.
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| Ages Eligible for Study: | 50 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02515045
| United States, Minnesota | |
| Minnesota Eye Consultants, P.A. | |
| Bloomington, Minnesota, United States, 55431 | |
| Associated Eye Care | |
| Stillwater, Minnesota, United States, 55082 | |
| United States, New York | |
| Ophthalmic Consultants of Long Island | |
| Garden City, New York, United States, 11530 | |
| United States, South Carolina | |
| Carolina Eyecare Physicians, LLC | |
| Mount Pleasant, South Carolina, United States, 29464 | |
| Principal Investigator: | Kerry D Solomon, MD | Carolina Eyecare Physicians, LLC |
| Responsible Party: | Carolina Eyecare Physicians, LLC |
| ClinicalTrials.gov Identifier: | NCT02515045 |
| Other Study ID Numbers: |
CEP 14-002 |
| First Posted: | August 4, 2015 Key Record Dates |
| Results First Posted: | August 22, 2017 |
| Last Update Posted: | February 23, 2018 |
| Last Verified: | January 2018 |
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Cataract Surgery Prophylaxis |
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Cataract Lens Diseases Eye Diseases Moxifloxacin Prednisolone Methylprednisolone Acetate Methylprednisolone Methylprednisolone Hemisuccinate Prednisolone acetate Nepafenac Prednisolone hemisuccinate Prednisolone phosphate Anti-Inflammatory Agents Glucocorticoids Hormones |
Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents Neuroprotective Agents Protective Agents Anti-Bacterial Agents Anti-Infective Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors |