A Randomized Study in Children Ages Birth Through Three Years Undergoing Unilateral Cataract Extr… (NCT02132312) | Clinical Trial Compass
CompletedPhase 3
A Randomized Study in Children Ages Birth Through Three Years Undergoing Unilateral Cataract Extraction With or Without Lens Replacement
United States78 participantsStarted 2014-07
Plain-language summary
The purpose of this study is to evaluate the effect of OMS302 compared to phenylephrine when administered in irrigation solution during cataract extraction on intraoperative pupil diameter, acute postoperative pain, and safety in children birth through 3 years.
Who can participate
Age range1 Day – 47 Months
SexALL
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Inclusion criteria
✓. Are 0 through three years of age at the time of surgery.
✓. Are to undergo unilateral primary cataract extraction with or without lens replacement.
✓. Have informed consent and Health Insurance Portability and Accountability Act (HIPAA) Authorization provided by a parent or legal guardian in accordance with local regulations and governing IRB/IEC requirements prior to any procedures or evaluations performed specifically for the sole purpose of this study.
✓. A parent or legal guardian has indicated that they understand and are able, willing, and likely to fully comply with study procedures and restrictions.
Exclusion criteria
✕. Corneal diameter less than nine millimeters in the study eye.
✕. Hypersensitivity to phenylephrine, ketorolac, or other NSAIDs, including aspirin, or latex.
✕. Surgeon's expectation that the protocol-specified mydriatic regimen will not be adequate to perform the procedure and that additional mydriatic treatment (pharmacological or mechanical) will be required.
✕. Presence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, endocrine, neurological, psychiatric, respiratory, or other medical condition that could increase the risk to the subject as determined by the Investigator.
✕. Presence of active or suspected viral, bacterial, or fungal disease in the study eye.
✕. Use of any topical medication in the study eye within seven days prior to surgery, except for medications needed to examine the eye or prepare for surgery.
What they're measuring
1
Intraoperative Pupil Diameter
Timeframe: From surgery baseline (pre-incision) through surgery end (time of cortical clean-up/wound closure), the mean time of surgery duration is 35.46 minutes with a standard deviation of 19.98.
2
Acute Postoperative Pain
Timeframe: 24 hours
3
Safety as Measured by Treatment-emergent Adverse Events, the Number of Affected Patients/at Risk (%) and the Number of Events.