Trial Outcomes & Findings for Effect of Topical Aqueous Suppressants on Intraocular Gas Duration Following Pars Plana Vitrectomy (NCT NCT01257698)
NCT ID: NCT01257698
Last Updated: 2019-09-04
Results Overview
Patients will self-monitor gas bubble duration and will receive weekly phone calls by the study coordinator until gas disappearance is confirmed.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
21 participants
Primary outcome timeframe
Up to 4 weeks
Results posted on
2019-09-04
Participant Flow
Participant milestones
| Measure |
Dorzolamide-timolol Topical Drops
Dorzolamide 2%-timolol 0.5% topical eyedrops: Dorzolamide 2%-timolol 0.5%, 1 drop in operated eye twice daily until gas bubble completely resorbed. Patients randomized to this arm are instructed to use this drop in addition to standard post-operative eye drops.
|
Standard of Care
Standard post-operative drops
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
9
|
|
Overall Study
COMPLETED
|
8
|
9
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
| Measure |
Dorzolamide-timolol Topical Drops
Dorzolamide 2%-timolol 0.5% topical eyedrops: Dorzolamide 2%-timolol 0.5%, 1 drop in operated eye twice daily until gas bubble completely resorbed. Patients randomized to this arm are instructed to use this drop in addition to standard post-operative eye drops.
|
Standard of Care
Standard post-operative drops
|
|---|---|---|
|
Overall Study
Protocol Violation
|
4
|
0
|
Baseline Characteristics
Effect of Topical Aqueous Suppressants on Intraocular Gas Duration Following Pars Plana Vitrectomy
Baseline characteristics by cohort
| Measure |
Dorzolamide-timolol Topical Drops
n=8 Participants
Dorzolamide 2%-timolol 0.5% topical eyedrops: Dorzolamide 2%-timolol 0.5%, 1 drop in operated eye twice daily until gas bubble completely resorbed. Patients randomized to this arm are instructed to use this drop in addition to standard post-operative eye drops.
|
Standard of Care
n=9 Participants
Standard post-operative drops
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
9 participants
n=7 Participants
|
17 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 4 weeksPatients will self-monitor gas bubble duration and will receive weekly phone calls by the study coordinator until gas disappearance is confirmed.
Outcome measures
| Measure |
Dorzolamide-timolol Topical Drops
n=8 Participants
Dorzolamide 2%-timolol 0.5% topical eyedrops: Dorzolamide 2%-timolol 0.5%, 1 drop in operated eye twice daily until gas bubble completely resorbed. Patients randomized to this arm are instructed to use this drop in addition to standard post-operative eye drops.
|
Standard of Care
n=9 Participants
|
|---|---|---|
|
Duration of Intraocular Gas
|
17.1 days
Standard Deviation 1.6
|
18.1 days
Standard Deviation 2.4
|
Adverse Events
Dorzolamide-timolol Topical Drops
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard of Care
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