Scleral Buckling
Conditions
Keywords
eye, pneumatic retinopexy, topical
Brief summary
A controlled clinical study comparing the effect of topical aqueous suppressants on intraocular gas duration.
Detailed description
A Prospective, Randomized Study Comparing the Effects of Topical Aqueous Suppressants on Intraocular Gas Duration following Scleral Buckling and Pneumatic Retinopexy
Interventions
DRUGTimolol-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.
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
Sponsors
Jason Hsu, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ability to provide written informed consent and comply with study assessments for the full duration of the study. * Have undergone eye surgery including scleral buckling or pneumatic retinopexy for treatment of retinal detachment other condition at the discretion of the investigator.
Exclusion criteria
* Prior surgery to treat glaucoma. * Current use of glaucoma eye drops. * Absence of a lens in the eye or presence of a lens implant in front of the iris (colored part of your eye). * Allergy or contraindication to any of the glaucoma drops being used in this study (e.g., sulfa allergy, asthma, chronic obstructive pulmonary disease (bronchitis or emphysema), slow heart rate).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Resolution of Intraocular Gas Bubble | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Return of Intraocular Pressure to Normal Levels | Month 2 | Number of participants with a normal intraocular pressure of 10-21 mm Hg at the Month 2 visit |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 12 |
| 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 | 9 |
| Total | 21 |
Baseline characteristics
| Characteristic | Post Surgery Without Glaucoma Drops | Post Surgery With Glaucoma Drops | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 2 Participants | 7 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 7 Participants | 14 Participants |
| Region of Enrollment United States | 12 participants | 9 participants | 21 participants |
| Sex: Female, Male Female | 5 Participants | 3 Participants | 8 Participants |
| Sex: Female, Male Male | 7 Participants | 6 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 12 | 0 / 9 |
| serious Total, serious adverse events | 0 / 12 | 0 / 9 |
Outcome results
Primary
Complete Resolution of Intraocular Gas Bubble
This will be reported by the patient when they see/feel the gas bubble disappear.
Time frame: Following surgery, until gas bubble is gone. Up to 2 months.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Post Surgery Without Glaucoma Drops | Complete Resolution of Intraocular Gas Bubble | 40.4 Duration in days, gas bubble |
| Post Surgery With Glaucoma Drops | Complete Resolution of Intraocular Gas Bubble | 37.8 Duration in days, gas bubble |
Secondary
Number of Participants With Return of Intraocular Pressure to Normal Levels
Number of participants with a normal intraocular pressure of 10-21 mm Hg at the Month 2 visit
Time frame: Month 2
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Post Surgery Without Glaucoma Drops | Number of Participants With Return of Intraocular Pressure to Normal Levels | High IOP at Month 2 | 1 Participants |
| Post Surgery Without Glaucoma Drops | Number of Participants With Return of Intraocular Pressure to Normal Levels | Normal IOP at Month 2 | 7 Participants |
| Post Surgery Without Glaucoma Drops | Number of Participants With Return of Intraocular Pressure to Normal Levels | Low IOP at Month 2 | 1 Participants |
| Post Surgery Without Glaucoma Drops | Number of Participants With Return of Intraocular Pressure to Normal Levels | Data Not Available | 3 Participants |
| Post Surgery With Glaucoma Drops | Number of Participants With Return of Intraocular Pressure to Normal Levels | Data Not Available | 2 Participants |
| Post Surgery With Glaucoma Drops | Number of Participants With Return of Intraocular Pressure to Normal Levels | High IOP at Month 2 | 0 Participants |
| Post Surgery With Glaucoma Drops | Number of Participants With Return of Intraocular Pressure to Normal Levels | Low IOP at Month 2 | 0 Participants |
| Post Surgery With Glaucoma Drops | Number of Participants With Return of Intraocular Pressure to Normal Levels | Normal IOP at Month 2 | 7 Participants |