Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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 medications. This will be a prospective evaluation of patients having routine, bilateral cataract surgery in which one eye of each subject will be randomized to receive a "conventional" regimen and the other eye will receive a regimen of "less drops". The "less drops" regimen will include EITHER (by randomization) a 0.1 cc subconjunctival injection of triamcinolone 40mg/mL (Triesence) at the end of surgery OR postoperative administration of topical clobetasol 0.05% (Byqlovi) BID for 14 days to deliver corticosteroid. Both steroid regimens will be delivered with nepafenac 0.3% QD for 14 days as a topical NSAID, and intracameral moxifloxacin 0.5% QID for 7 days as an antibiotic. The "conventional" topical medication regimen will include prednisolone acetate 1% QID, ketorolac 0.5% QID , and moxifloxacin 0.5% topical drops QID. With all of these treatment regimens, the patients will be receiving two on-label, FDA approved products and one (intracameral moxifloxacin) that is technically off-label but is so well accepted that it is used in approximately half the cataract surgery performed in the US. . In all patients the fellow eye will act as the control.
Patients will be evaluated at 1 day, 1 week and 1 month postoperatively. Measurements are listed in the visit schedule table below. Patients will also be subjectively asked about their symptoms of pain and photophobia and be asked about their acceptance, cost, and which treatment protocol they preferred.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | Triesence or Byqlovi Arm with nepafenac |
|
| Control Group | Active Comparator | Topical Moxifloxacin, Ketorolac, Prednisolone Acetate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triamcinolone (Optional) | Drug | triamcinolone 40mg/ml or topical clobetasol 0.05% with nepafenac 0.3% QD for 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary | Patient Preference Between Medication Protocols (COMTOL Questionnaire Question 1) | 14 days after cataract surgery in each eye |
| Primary | Patient preference for medication protocol between the two eyes, as reported based on the question, "Thinking about your overall experience taking medications in each eye after surgery, which eye did you prefer?" (question 1 from validated COMTOL questionnaire) | 14 days after cataract surgery in each eye |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-Reported Postoperative Ocular Pain Severity Using a 0-10 Visual Analog Scale | Study subject evaluation of post-op ocular pain using a visual analog scale with pain ranking from 0 to 10 (10 high) with the request, "Please rate the severity of discomfort caused by your eye medicines at their worst point." | 14 days after cataract surgery in each eye |
| Measure | Description | Time Frame |
|---|---|---|
| Summed Ocular Inflammation Score at One Week (Anterior Chamber Cells + Flare) | Summed Ocular Inflammation Score (sum of the mean anterior chamber cells and anterior flare score) at one week. | 7 days after cataract surgery in each eye |
Inclusion Criteria:
Exclusion Criteria:
Intra-Operative Exclusion Criteria (Surgical Complications):
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| John Hovanesian, MD | Contact | 949-951-2020 | jhovanesian@researchinsight.com | |
| Leslie Lemieux, MHA | Contact | research@researchinsightca.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harvard Eye Associates | Laguna Hills | California | 92653 | United States |
Not provided
| ID | Term |
|---|---|
| D014221 | Triamcinolone |
| D002990 | Clobetasol |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| control group | Drug | topical medication regimen will include prednisolone acetate 1% QID, ketorolac 0.5% QID, and moxifloxacin 0.5% topical drops QID. |
|
| D011083 |
| Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001623 | Betamethasone |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |