Trial Outcomes & Findings for The Effect of Glaucoma Drops on of the Duration of a Pure Intraocular Gas Bubble (NCT NCT01843920)
NCT ID: NCT01843920
Last Updated: 2018-05-30
Results Overview
This will be reported by the patient when they see/feel the gas bubble disappear.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
21 participants
Primary outcome timeframe
Following surgery, until gas bubble is gone. Up to 2 months.
Results posted on
2018-05-30
Participant Flow
Participant milestones
| Measure |
Post Surgery Without Glaucoma Drops
This will be for the group that had gas duration surgery using SF6 (Sulfur Hexafluoride) or C3F8 (perfluoropropane gas tamponade) and only uses the standard post-operative topical drops.
standard post-operative topical drops: Patients will receive the standard post-operative drops regardless of what group ther are in. The standard post-operative drops are Prednisolone acetate,Polymyxin B and Trimethoprim
|
Post Surgery With Glaucoma Drops
This will be for the group that had gas duration surgery (using SF6 or C3F8). In addition to the standard post-operative topical drops, glaucoma drops, Timolol-dorzolamide (timolol 0.5%-dorzolamide 2%) will be given.
Timolol-dorzolamide (Glaucoma drops): Patients will receive the standard post-operative drops regardless of what group you are in. The glaucoma drops will only be given to the experimental group.
standard post-operative topical drops: Patients will receive the standard post-operative drops regardless of what group ther are in. The standard post-operative drops are Prednisolone acetate,Polymyxin B and Trimethoprim
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
9
|
|
Overall Study
COMPLETED
|
12
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effect of Glaucoma Drops on of the Duration of a Pure Intraocular Gas Bubble
Baseline characteristics by cohort
| Measure |
Post Surgery Without Glaucoma Drops
n=12 Participants
This will be for the group that had gas duration surgery using SF6 (Sulfur Hexafluoride) or C3F8 (perfluoropropane gas tamponade) and only uses the standard post-operative topical drops.
standard post-operative topical drops: Patients will receive the standard post-operative drops regardless of what group ther are in. The standard post-operative drops are Prednisolone acetate,Polymyxin B and Trimethoprim
|
Post Surgery With Glaucoma Drops
n=9 Participants
This will be for the group that had gas duration surgery (using SF6 or C3F8). In addition to the standard post-operative topical drops, glaucoma drops, Timolol-dorzolamide (timolol 0.5%-dorzolamide 2%) will be given.
Timolol-dorzolamide (Glaucoma drops): Patients will receive the standard post-operative drops regardless of what group you are in. The glaucoma drops will only be given to the experimental group.
standard post-operative topical drops: Patients will receive the standard post-operative drops regardless of what group ther are in. The standard post-operative drops are Prednisolone acetate,Polymyxin B and Trimethoprim
|
Total
n=21 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
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
9 participants
n=7 Participants
|
21 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Following surgery, until gas bubble is gone. Up to 2 months.This will be reported by the patient when they see/feel the gas bubble disappear.
Outcome measures
| Measure |
Post Surgery Without Glaucoma Drops
n=12 Participants
This will be for the group that had gas duration surgery using SF6 (Sulfur Hexafluoride) or C3F8 (perfluoropropane gas tamponade) and only uses the standard post-operative topical drops.
standard post-operative topical drops: Patients will receive the standard post-operative drops regardless of what group ther are in. The standard post-operative drops are Prednisolone acetate,Polymyxin B and Trimethoprim
|
Post Surgery With Glaucoma Drops
n=9 Participants
This will be for the group that had gas duration surgery (using SF6 or C3F8). In addition to the standard post-operative topical drops, glaucoma drops, Timolol-dorzolamide (timolol 0.5%-dorzolamide 2%) will be given.
Timolol-dorzolamide (Glaucoma drops): Patients will receive the standard post-operative drops regardless of what group you are in. The glaucoma drops will only be given to the experimental group.
standard post-operative topical drops: Patients will receive the standard post-operative drops regardless of what group ther are in. The standard post-operative drops are Prednisolone acetate,Polymyxin B and Trimethoprim
|
|---|---|---|
|
Complete Resolution of Intraocular Gas Bubble
|
40.4 Duration in days, gas bubble
Interval 27.0 to 51.0
|
37.8 Duration in days, gas bubble
Interval 29.0 to 50.0
|
SECONDARY outcome
Timeframe: Month 2Number of participants with a normal intraocular pressure of 10-21 mm Hg at the Month 2 visit
Outcome measures
| Measure |
Post Surgery Without Glaucoma Drops
n=12 Participants
This will be for the group that had gas duration surgery using SF6 (Sulfur Hexafluoride) or C3F8 (perfluoropropane gas tamponade) and only uses the standard post-operative topical drops.
standard post-operative topical drops: Patients will receive the standard post-operative drops regardless of what group ther are in. The standard post-operative drops are Prednisolone acetate,Polymyxin B and Trimethoprim
|
Post Surgery With Glaucoma Drops
n=9 Participants
This will be for the group that had gas duration surgery (using SF6 or C3F8). In addition to the standard post-operative topical drops, glaucoma drops, Timolol-dorzolamide (timolol 0.5%-dorzolamide 2%) will be given.
Timolol-dorzolamide (Glaucoma drops): Patients will receive the standard post-operative drops regardless of what group you are in. The glaucoma drops will only be given to the experimental group.
standard post-operative topical drops: Patients will receive the standard post-operative drops regardless of what group ther are in. The standard post-operative drops are Prednisolone acetate,Polymyxin B and Trimethoprim
|
|---|---|---|
|
Number of Participants With Return of Intraocular Pressure to Normal Levels
High IOP at Month 2
|
1 Participants
|
0 Participants
|
|
Number of Participants With Return of Intraocular Pressure to Normal Levels
Normal IOP at Month 2
|
7 Participants
|
7 Participants
|
|
Number of Participants With Return of Intraocular Pressure to Normal Levels
Low IOP at Month 2
|
1 Participants
|
0 Participants
|
|
Number of Participants With Return of Intraocular Pressure to Normal Levels
Data Not Available
|
3 Participants
|
2 Participants
|
Adverse Events
Post Surgery Without Glaucoma Drops
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Post Surgery With Glaucoma Drops
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