The TRIBECA Study (TRIessence/Byqlovi for Easier CAtaract Surgery)
Research Insight LLC
Summary
A self-controlled, prospective clinical study of the safety, clinical efficacy, and patient acceptance of subconjunctival delivery of triamcinolone 40 mg/mL (Triesence) at the conclusion of cataract surgery or topical clobetasol 0.05 (Byqlovi) BID for 14 days, with intracameral moxifloxacin 0.5%, and topical nepafenac 0.3% (Ilevro) for 14 days, as compared to traditional topical postoperative prednisolone acetate 1% QID, moxifloxacin 0.5% drops QID, and ketorolac 0.5% QID in controlling postoperative pain and inflammation in subjects undergoing sequential bilateral cataract surgery.
Description
Drug delivery is one of the most exciting advances in ophthalmology, and with new products available comes the opportunity for an improved patient experience in cataract surgery. Frequent use of topical medications is associated with difficulty in application and compliance for many patients and create a burden for family members. In addition there is a cost to many patients that presents financial obstacles. The purpose of this study is to evaluate the safety, effectiveness and patient acceptance of two post cataract surgery drug treatment regimens that minimize the use of topical medication…
Eligibility
- Age range
- 22+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * A male or female subject in good general health, \> 22 years of age at the time of the screening visit * A subject must be able to comprehend and willing to give informed consent * A woman of child-bearing potential must not be pregnant or lactating. * A subject has the availability, willingness and sufficient cognitive awareness to comply with exam procedures and able to return for all scheduled study visits * A subject with a cataract for which routine phacoemulsification extraction and implantation of an intraocular lens has been planned * A subject with clear ocular…
Interventions
- DrugTriamcinolone (Optional)
triamcinolone 40mg/ml or topical clobetasol 0.05% with nepafenac 0.3% QD for 14 days
- Drugcontrol group
topical medication regimen will include prednisolone acetate 1% QID, ketorolac 0.5% QID, and moxifloxacin 0.5% topical drops QID.
Location
- Harvard Eye AssociatesLaguna Hills, California