Dropless™ vs. Less Drops™ Pharmaceutical Regimens After Cataract Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02819908|
Recruitment Status : Completed
First Posted : June 30, 2016
Last Update Posted : June 30, 2016
To compare the relative effectiveness of the Imprimis Dropless™ (TriMoxiVanc) intraocular solution with the Less Drops™ topical formulation of PredMoxiKeterolac (given for the first week post op) followed by PredKeterolac (given for weeks 2 to 4 after surgery).
The hypothesis is that the "dropless" regimen will be non-inferior to the "less drops" regimen in terms of post-operative IOP changes, post-operative healing, and visual quality.
|Condition or disease||Intervention/treatment||Phase|
|Intraocular Lens Associated Postoperative Inflammation||Drug: Imprimis Dropless Drug: Imprimis Less Drops||Phase 4|
Modern cataract surgery has become a relatively short out-patient procedure with small incisions and short post-operative recovery time. Surgery can be influenced by surgical technique and experience. Prophylactic pharmaceutical regimens are designed to control post-operative pain and to reduce the potential for inflammation (i.e. macular edema, CME) and infection (i.e. endophthalmitis).
The most serious potential infection related to cataract surgery is endophthalmitis. Endophthalmitis is a result of microorganisms entering the eye, either during the surgical procedure or before surgical incisions have healed completely. The risk of infection can be reduced in several ways. Pre-operatively, reducing the bacteria on the cornea and ocular adnexa can be helpful. During surgery, appropriate technique can reduce the potential for ingress. Post-operatively, prophylactic antibiotics can eliminate organisms once they have entered the eye. Topical drops, intracameral antibiotics and subconjunctival injections are typical options in current use, usually selected on the basis of spectrum of coverage, cost, efficacy and/or expected side effects.
With regard to inflammation, one of the most common post-operative responses is cystoid macular edema (CME). Steroids and non-steroidal anti-inflammatory drugs (NSAIDs) appear effective in reducing the incidence of CME, with NSAIDs posing a lower risk for IOP spikes and showing greater efficacy some studies.
While there is documented evidence of the utility of prophylactic post-operative treatment for pain and infection, patient compliance remains a significant concern. The regimen is often complex, with multiple drops several times per day. Inability to instill the drops, forgetfulness and a lack of appreciation for the importance of compliance can all be contributing factors.
There are several new options to try to address the potential issues related to poor patient compliance. One is referred to as "dropless" cataract surgery, which involves injection of a multi-drug compound into the eye at time of cataract surgery; one such compound includes triamcinolone acetonide, moxifloxacin hydrochloride and vancomycin (TriMoxiVanc). Another alternative is to reduce the burden of the pharmaceutical regimen using a compounded topical medication; this is termed "less drops" cataract surgery. An option in this regard is a topical formulation of prednisolone acetate, moxifloxacin hydrochloride and ketorolac tromethamine (PredMoxiKetorolac), given for one week post-operatively followed by a topical formulation of prednisolone acetate and ketorolac tromethamine (PredKeterolac) given for weeks 2 to 4 after surgery.
The purpose of this study is to evaluate the differences in performance between the dropless and less-drops pharmaceutical regimens after cataract surgery.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Dropless™ vs. Less Drops™ Pharmaceutical Regimens After Cataract Surgery|
|Study Start Date :||September 2015|
|Actual Primary Completion Date :||April 2016|
|Actual Study Completion Date :||April 2016|
Active Comparator: Imprimis Dropless
TriMoxiVanc 0.2cc intravitreal one time
Drug: Imprimis Dropless
Tri-Moxi-Vanc transzonular intravitreal injection
Active Comparator: Imprimis Less Drops
Pred Moxi, 1 drop tid for 1 week then, PredKeterolac bid for 2-4 weeks.
Drug: Imprimis Less Drops
Pred-Moxi-Ketorolac and Pred-Ketorolac topical instillation qd postoperatively
- The change in intraocular pressure (IOP) from baseline [ Time Frame: To end of study (1 month postop) ]Based on Goldmann tonometry
- Change in corneal thickness [ Time Frame: To end of study (1 month postop) ]Based on corneal pachymetry
- Slit lamp (cornea exam) [ Time Frame: To end of study (1 month postop) ]
- Subject reporting no eye pain [ Time Frame: To end of study (1 month postop) ]"0"( on the eye pain/discomfort scale)
- Change from baseline eye pain/discomfort [ Time Frame: To end of study (1 month postop) ]eye pain/discomfort scale
- The proportion of subjects reporting no visual symptoms ("0" ) [ Time Frame: To end of study (1 month postop) ]visual symptom scale
- The change from baseline in visual symptoms [ Time Frame: To end of study (1 month postop) ]visual symptom scale
- The change from baseline in central corneal thickness measurements [ Time Frame: To end of study (1 month postop) ]corneal pachymetry
- The change from baseline in macular thickness measurements [ Time Frame: To end of study (1 month postop) ]based on optical coherence tomography (OCT) measurement
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): NCT02819908
|United States, Florida|
|Eye Center of North Florida|
|Panama city, Florida, United States, 32409|
|Principal Investigator:||Bret L Fisher, MD||Eye Center of North Florida|