Clinical trial NCT02515045: Dropless vs. Standard Drops Contralateral Eye Study
Official title: Comparison of Dropless Prophylaxis After Routine Phacoemulsification to Standard Drops Regimen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cataract
Keywords: Cataract
Surgery
Prophylaxis
Lead sponsor: Carolina Eyecare Physicians, LLC
Sponsor class: OTHER
Collaborators: name: Science in Vision
First posted: 2015-08-04
Enrollment: 59
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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%.

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.

Primary outcomes:
measure: Change From Baseline (Preoperative Exam) in Macular Thickness
timeFrame: Month 1.
Secondary outcomes:
measure: Change From Baseline (Preoperative Exam) in Pachymetry (Corneal Thickness)
timeFrame: Month 1
measure: Change From Baseline (Preoperative Exam) in Intraocular Pressure (IOP)
timeFrame: Month 1.
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: Minnesota Eye Consultants, P.A.
state: Minnesota
city: Stillwater
country: United States
facility: Associated Eye Care
state: Minnesota
city: Garden City
country: United States
facility: Ophthalmic Consultants of Long Island
state: New York
city: Mount Pleasant
country: United States
facility: Carolina Eyecare Physicians, LLC
state: South Carolina
Study officials:
affiliation: Carolina Eyecare Physicians, LLC
name: Kerry D Solomon, MD
role: PRINCIPAL_INVESTIGATOR
References: