Trial Outcomes & Findings for Comparison of Epinephrine and Phenylephrine/Ketorolac With Regards to Pupil Size (NCT NCT02895035)
NCT ID: NCT02895035
Last Updated: 2020-01-31
Results Overview
Mean area under the curve was calculated by assessing the pupil diameter at baseline and then again at 1 minute intervals until the surgery was complete (max 20 minutes). Units are in millimeters\*seconds
TERMINATED
PHASE4
59 participants
During cataract surgery, with maximum end time of 20 minutes
2020-01-31
Participant Flow
All patients who presented to one of two attending ophthalmologist's (MCC or SMP) clinics at Penn State Eye Center for cataract evaluation between November 10, 2016 and February 8, 2018 and met inclusion/exclusion criteria were invited to participate in the study. There were no incentives provided to patients for enrolling in the study.
Participant milestones
| Measure |
Epinephrine (1 Day), Washout (21 Days), Then Omidria (1 Day)
Patients in this arm received epinephrine during the first eye surgery. Patients then waited (washout) 21 days before proceeding with second eye surgery. Patients then received Omidria during the second eye surgery.
|
Omidria (1 Day), Washout (21 Days), Then Epinephrine (1 Day)
Patients in this arm received Omidria during the first eye surgery. Patients then waited (washout) 21 days before proceeding with second eye surgery. Patients then received epinephrine during the second eye surgery.
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
36
|
|
Overall Study
COMPLETED
|
18
|
24
|
|
Overall Study
NOT COMPLETED
|
5
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Epinephrine and Phenylephrine/Ketorolac With Regards to Pupil Size
Baseline characteristics by cohort
| Measure |
All Participants
n=42 Participants
All Participants were randomized to receive all interventions. Therefore, the baseline characteristics are grouped as "all participants"
|
|---|---|
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Age, Continuous
|
73.1 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
40 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
42 participants
n=5 Participants
|
|
Tamsulosin Use
Tamsulosin
|
1 Participants
n=5 Participants
|
|
Tamsulosin Use
No Tamsulosin
|
41 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During cataract surgery, with maximum end time of 20 minutesPopulation: Two eyes from each participant were included for all outcome measures.
Mean area under the curve was calculated by assessing the pupil diameter at baseline and then again at 1 minute intervals until the surgery was complete (max 20 minutes). Units are in millimeters\*seconds
Outcome measures
| Measure |
Epinephrine
n=42 Eyes
Epinephrine is the intracameral additive during cataract surgery.
Epinephrine: Epinephrine is a nonselective adrenergic agonist added to the irrigation solution during cataract surgery.
|
Omidria
n=42 Eyes
Omidria is the intracameral additive during cataract surgery.
Phenylephrine-ketorolac: Pehnylephrine-ketorolac is a combination of an alpha-one agonist (phenylephrine) and an NSAID (ketorolac). One 4-mL bottle of 1% phenylephrine/3% ketorolac is added to the irrigation solution during cataract surgery.
|
|---|---|---|
|
Mean Area Under the Curve Change From Baseline in Pupil Diameter Over Time to the End of Cataract Surgery
|
1.76 millimeters * seconds
Standard Deviation 6.51
|
0.8 millimeters * seconds
Standard Deviation 12.01
|
SECONDARY outcome
Timeframe: During cataract surgery, with maximum end time of 20 minutesPopulation: Two eyes from each participant were included
This is the maximum observed change in pupil diameter, as measured compared to baseline.
Outcome measures
| Measure |
Epinephrine
n=42 Eyes
Epinephrine is the intracameral additive during cataract surgery.
Epinephrine: Epinephrine is a nonselective adrenergic agonist added to the irrigation solution during cataract surgery.
|
Omidria
n=42 Eyes
Omidria is the intracameral additive during cataract surgery.
Phenylephrine-ketorolac: Pehnylephrine-ketorolac is a combination of an alpha-one agonist (phenylephrine) and an NSAID (ketorolac). One 4-mL bottle of 1% phenylephrine/3% ketorolac is added to the irrigation solution during cataract surgery.
|
|---|---|---|
|
Maximum Intraoperative Change in Pupil Diameter
|
-0.71 millimeters
Standard Deviation 0.57
|
-0.66 millimeters
Standard Deviation 0.79
|
SECONDARY outcome
Timeframe: During cataract surgery, with maximum end time of 20 minutesPopulation: Each participant had two eyes included in the study
Number of eyes with a measured pupil diameter less than 6 mm at any time during surgery
Outcome measures
| Measure |
Epinephrine
n=42 Eyes
Epinephrine is the intracameral additive during cataract surgery.
Epinephrine: Epinephrine is a nonselective adrenergic agonist added to the irrigation solution during cataract surgery.
|
Omidria
n=42 Eyes
Omidria is the intracameral additive during cataract surgery.
Phenylephrine-ketorolac: Pehnylephrine-ketorolac is a combination of an alpha-one agonist (phenylephrine) and an NSAID (ketorolac). One 4-mL bottle of 1% phenylephrine/3% ketorolac is added to the irrigation solution during cataract surgery.
|
|---|---|---|
|
Number of Eyes With Pupil Diameter Less Than 6 mm at Any Time During Surgery
|
3 Eyes
|
2 Eyes
|
SECONDARY outcome
Timeframe: During cataract surgery, cortical clean-up stage, up to 5 minsPopulation: Each participant had two eyes included in the study
Number of eyes with a measured pupil diameter less than 6 mm during cortical clean-up
Outcome measures
| Measure |
Epinephrine
n=42 Eyes
Epinephrine is the intracameral additive during cataract surgery.
Epinephrine: Epinephrine is a nonselective adrenergic agonist added to the irrigation solution during cataract surgery.
|
Omidria
n=42 Eyes
Omidria is the intracameral additive during cataract surgery.
Phenylephrine-ketorolac: Pehnylephrine-ketorolac is a combination of an alpha-one agonist (phenylephrine) and an NSAID (ketorolac). One 4-mL bottle of 1% phenylephrine/3% ketorolac is added to the irrigation solution during cataract surgery.
|
|---|---|---|
|
Number of Eyes With Pupil Diameter Less Than 6 mm During Cortical Clean-up
|
3 Eyes
|
2 Eyes
|
Adverse Events
Epinephrine
Omidria
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place