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| ID | Type | Description | Link |
|---|---|---|---|
| 11-095 | Other Identifier | Wills Eye IRB |
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A controlled clinical study comparing the effect of topical aqueous suppressants on intraocular gas duration.
A Prospective, Randomized Study Comparing the Effects of Topical Aqueous Suppressants on Intraocular Gas Duration following Scleral Buckling and Pneumatic Retinopexy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Post surgery without glaucoma drops | Active Comparator | 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. |
|
| Post surgery with glaucoma drops | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Timolol-dorzolamide (Glaucoma drops) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Resolution of Intraocular Gas Bubble | This will be reported by the patient when they see/feel the gas bubble disappear. | Following surgery, until gas bubble is gone. Up to 2 months. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Month 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason Hsu, MD | Wills Eye Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mid Atlantic Retina- Wills Eye Institute | Philadelphia | Pennsylvania | 19107 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Complete Resolution of Intraocular Gas Bubble | This will be reported by the patient when they see/feel the gas bubble disappear. | Posted | Mean | Full Range | Duration in days, gas bubble | Following surgery, until gas bubble is gone. Up to 2 months. |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jason Hsu, MD | Mid Atlantic Retina | 215-928-3092 | research@midatlanticretina.com |
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| ID | Term |
|---|---|
| C479140 | dorzolamide-timolol combination |
| C062765 | dorzolamide |
| D059039 | Standard of Care |
| D000305 | Adrenal Cortex Hormones |
| D011239 | Prednisolone |
| D011112 | Polymyxin B |
| D014295 | Trimethoprim |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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|
| standard post-operative topical drops | Drug | 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 |
|
|
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | 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 |
|
|
| 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 | Posted | Count of Participants | Participants | Month 2 |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | 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 | 0 | 9 | 0 | 9 |
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| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011113 | Polymyxins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D055666 | Lipopeptides |
| D008055 | Lipids |
| D023181 | Antimicrobial Cationic Peptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000089882 | Antimicrobial Peptides |
| D052899 | Pore Forming Cytotoxic Proteins |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| Low IOP at Month 2 |
|
| Data Not Available |
|