Cataract
Conditions
Keywords
OMIDRIA
Brief summary
This is a multicenter, 2-arm, randomized, prospective study of patients slated for bilateral cataract extraction. One eye will be randomized to the Study Arm, and the fellow eye will be randomized to the Control Arm.
Detailed description
For the control arm interventions: Preoperatively, the Control Arm (control eye) will self-administer a regimen of ketorolac four times daily (QID) x 1 day and moxifloxacin drops three times daily (TID) x 1 day before surgery. On the Day of Surgery, eyes in the Control Arm will receive in-office drops administered by study staff according to the following schedule: * In pre-operative holding: 1 drop ketorolac, 1 drop moxifloxacin * Immediately prior to surgery: 1 drop ketorolac, 1 drop moxifloxacin * At the conclusion of surgery while still in the operating room: 1 drop ketorolac, 1 drop moxifloxacin, 1 drop prednisolone acetate * Any time in postoperative recovery: 1 drop ketorolac, 1 drop moxifloxacin, 1 drop prednisolone acetate Eyes in the Control Arm will then self-administer the following postoperative interventions: ketorolac drops QID x 1 month, prednisolone acetate tapering QID x1 week, TID x 1 week, twice daily (BID) x 1 week, and once daily (QD) x 1 week; and moxifloxacin drops TID x 1 week. For the study arm interventions: Eyes will receive in-office drops on the Day of Surgery administered by study staff according to the following schedule: * In pre-operative holding: 1 drop ketorolac, 1 drop moxifloxacin * Immediately prior to surgery: 1 drop ketorolac, 1 drop moxifloxacin * At the conclusion of surgery while still in the operating room: 1 drop ketorolac, 1 drop moxifloxacin, 1 drop prednisolone acetate * Any time in postoperative recovery: 1 drop ketorolac, 1 drop moxifloxacin, 1 drop prednisolone acetate. Eyes in the Study Arm will be treated with the following intraoperative interventions: intracameral phenylephrine 1.0%/ketorolac 0.3%, intracameral moxifloxacin, and subconjunctival triamcinolone acetonide. The following study assessments will take place for all subjects: Visual acuity measured by the Early Treatment of Diabetic Retinopathy Study (ETDRS) chart (pinhole visual acuity \[VA\] or best corrected visual acuity \[BCVA\]) * Slit lamp examination, including intraocular pressure (IOP) measurement * Grading of inflammation * Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire * Pain assessment on a 0-4 scale * Overall participant satisfaction on a 0-10 scale * Optical coherence tomography (OCT) imaging Eyes in the Study Arm will also receive in-office drops administered by study staff at the end of the 1-day visit: 1 drop ketorolac, 1 drop moxifloxacin, 1 drop prednisolone acetate. Rescue therapy for postoperative inflammation will be allowed for Study Arm participants, if necessary, at the discretion of the evaluating physician and will consist of prednisolone acetate QID (taper also at the discretion of the evaluating physician).
Interventions
DRUGOmidria, {0.3%-1% Intraocular Solution}, VIGAMOX {0.5% moxifloxacin hydrochloride}, Kenalog {0.4 ml, 10mg/ml, triamcinolone acetonide}
Eyes in the Study Arm will be treated with the following intraoperative interventions: Intracameral (OMIDRIA) phenylephrine 1.0%/ketorolac 0.3%, intracameral moxifloxacin (0.5%), and subconjunctival triamcinolone acetonide (0.4 mL, 10mgs/mL).
DRUGKetorolac (0.5%) {Toradol}, moxifloxacin (0.5%) {VIGAMOX}, prednisolone acetate (1%) {Pred Forte}
On the Day of Surgery, eyes in the Control Arm will receive in-office drops administered by study staff according to the following schedule: * In pre-operative holding: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%) * Immediately prior to surgery: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%) * At the conclusion of surgery while still in the operating room: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%), 1 drop prednisolone acetate (1%) * Any time in postoperative recovery: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%), 1 drop prednisolone acetate (1%)
Sponsors
The Eye Associates
Inder Paul Singh, M.D.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
The biostatistician analyzing the data will be masked to both treatment arm and surgery center. When the Investigators or Sponsor look at the data, they will also be masked to treatment arm and surgery center.
Intervention model description
This is a 2-arm non-inferiority trial with the following arms: * Control arm: Participants undergoing cataract surgery using conventional standard of care peri-operative eyedrops. * Study arm: Participants undergoing cataract surgery with a regimen of peri-operative topical eyedrops administered to the participant by study staff, in combination with intracameral phenylephrine 1.0%/ketorolac 0.3%, subconjunctival triamcinolone acetonide, and intracameral moxifloxacin.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult participants \> 18 years of age undergoing bilateral cataract surgery * Able to provide written informed consent prior to any study related procedure * Able and willing, as assessed by the Investigator, to follow study instructions, complete study assessments, comply with the protocol, and attend study visits for the duration of the study * Patients deemed to be higher risk for postoperative complications (e.g., well-controlled diabetes (HbA1c ≤7.0), history of uveitis, history of retinal vein occlusion, history of epiretinal membrane, history of vitreomacular traction, evidence of posterior synechiae, etc.) MAY be enrolled provided there has been no evidence of active disease or treatment in the prior 12 months * Participants who do not meet the
Exclusion criteria
may be enrolled.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| inflammation | 8 days | The proportion of participants with inflammation on Day 8. (Participants will be considered to have no inflammation (Grade 0) if they have ≤ 2 anterior chamber cells and are asymptomatic.) {Anterior Inflammation Scale, 0-4 with 4 being the worst or most severe score} |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SPEED Questionnaire | 30 days | Mean change in SPEED Questionnaire from baseline to Day 8 and baseline to Day 30 |
Countries
United States
Contacts
Primary ContactPaul Singh, MD
Backup ContactCathleen McCabe, MD
Outcome results
None listed