Trial Outcomes & Findings for Steroids After Laser Trabeculoplasty for Glaucoma (NCT NCT00981435)
NCT ID: NCT00981435
Last Updated: 2019-08-07
Results Overview
IOP will be measured before and at 6 and 12 weeks after intervention using Goldman tonometry.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
97 participants
Primary outcome timeframe
Baseline to Week 12
Results posted on
2019-08-07
Participant Flow
Participant milestones
| Measure |
Artificial Tears
Artificial Tears: Artificial saline tears to lasered eye 4 times/day for 4.5 days
|
Non-steroidal Anti-inflammatory
Diclofenac 0.1%: Diclofenac sodium 0.1% to lasered eye 4 times/day for 4.5 days
|
Steroid
Prednisolone 1%: Prednisolone 1% to lasered eye 4 times/day for 4.5 days
|
|---|---|---|---|
|
Overall Study
STARTED
|
31
|
29
|
37
|
|
Overall Study
COMPLETED
|
31
|
29
|
37
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Steroids After Laser Trabeculoplasty for Glaucoma
Baseline characteristics by cohort
| Measure |
Artificial Tears
n=31 Participants
Artificial Tears: Artificial saline tears to lasered eye 4 times/day for 4.5 days
|
Non-steroidal Anti-inflammatory
n=29 Participants
Diclofenac 0.1%: Diclofenac sodium 0.1% to lasered eye 4 times/day for 4.5 days
|
Steroid
n=37 Participants
Prednisolone 1%: Prednisolone 1% to lasered eye 4 times/day for 4.5 days
|
Total
n=97 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
66 years
STANDARD_DEVIATION 15 • n=93 Participants
|
60 years
STANDARD_DEVIATION 11 • n=4 Participants
|
67 years
STANDARD_DEVIATION 14 • n=27 Participants
|
65 years
STANDARD_DEVIATION 14 • n=483 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
56 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
41 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
26 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
67 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
21 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
29 Participants
n=27 Participants
|
75 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: Patient data was incomplete due to inadequate measurement or follow up as follows: Artificial tears (31 enrolled, 27 available at 6 weeks, 25 at 12 weeks); Non-steroidal anti-inflammatory (28 enrolled, 27 available at 6 and 12 weeks); Steroid (37 enrolled, 33 available at 6 weeks, 29 at 12 weeks).
IOP will be measured before and at 6 and 12 weeks after intervention using Goldman tonometry.
Outcome measures
| Measure |
Artificial Tears
n=25 Participants
Artificial Tears: Artificial saline tears to lasered eye 4 times/day for 4.5 days
|
Non-steroidal Anti-inflammatory
n=27 Participants
Diclofenac 0.1%: Diclofenac sodium 0.1% to lasered eye 4 times/day for 4.5 days
|
Steroid
n=29 Participants
Prednisolone 1%: Prednisolone 1% to lasered eye 4 times/day for 4.5 days
|
|---|---|---|---|
|
Intraocular Pressure (IOP) Change
|
-3.0 mmHg
Standard Deviation 4.3
|
-6.2 mmHg
Standard Deviation 3.1
|
-5.2 mmHg
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: Up to week 12Population: Patient data was incomplete due to inadequate measurement or follow up as follows: Artificial tears (31 enrolled, 31 available for data acquisition); Non-steroidal anti-inflammatory (29 enrolled, 26 available for data acquisition); Steroid (37 enrolled, 35 available for data acquisition).
The count of patients with inflammation defined as anterior chamber cells was measured in each study arm.
Outcome measures
| Measure |
Artificial Tears
n=31 Participants
Artificial Tears: Artificial saline tears to lasered eye 4 times/day for 4.5 days
|
Non-steroidal Anti-inflammatory
n=26 Participants
Diclofenac 0.1%: Diclofenac sodium 0.1% to lasered eye 4 times/day for 4.5 days
|
Steroid
n=35 Participants
Prednisolone 1%: Prednisolone 1% to lasered eye 4 times/day for 4.5 days
|
|---|---|---|---|
|
Intraocular Inflammation
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Artificial Tears
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-steroidal Anti-inflammatory
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Steroid
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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