Phase 4
N=118
Dropless vs. Standard Drops Contralateral Eye Study
Cataract
Bottom Line
View on ClinicalTrials.gov: NCT02515045 ↗Enrolled (actual)
118
Serious AEs
0.0%
Results posted
Aug 2017
Primary outcome: Primary: Change From Baseline (Preoperative Exam) in Macular Thickness — 12.34; 10.96; 9.84 Microns
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- TriMoxiVanc (Drug); Moxifloxacin HCl 0.5% (Drug); Ilevro (Drug); Prednisolone acetate 1% (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Carolina Eyecare Physicians, LLC
- Primary completion
- Mar 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline (Preoperative Exam) in Macular Thickness |
12.34; 10.96; 9.84 | — |
| SECONDARY Change From Baseline (Preoperative Exam) in Pachymetry (Corneal Thickness) |
14.44; 5.94; 4.47 | — |
| SECONDARY Change From Baseline (Preoperative Exam) in Intraocular Pressure (IOP) |
-0.5; -1.03; -1.1 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02515045). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.