Intraocular Lens Associated Postoperative Inflammation Clinical Trial
Official title:
Dropless™ vs. Less Drops™ Pharmaceutical Regimens After Cataract Surgery
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.
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06294405 -
Intraocular Lens Implant Registry Study
|