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The purpose of this study is to determine if Lotemax eye drops are at least as effective as Pred Forte eye drops, which are the standard of care after cataract surgery.
Prednisolone 1%, a topical steroid, is considered standard of care following cataract surgery to reduce inflammation. We aim to determine if Lotemax is at least as effective as Prednisolone. If so, these findings would demonstrate that physicians have other treatment options to consider.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pred Forte | Active Comparator | Patients scheduled to undergo phacoemulsification will be randomized in a 1:1 schedule to receive Pred Forte BID for 4 weeks postop. All patients will receive Xibrom BID for one month and Besifloxacin BID for 7 to 10 days postop. |
|
| Lotemax | Active Comparator | patients scheduled to undergo phacoemulsification will be randomized in a 1:1 schedule to receive Lotemax BID for 4 weeks postop. All patients will receive Xibrom BID for one month and Besifloxacin BID for 7 to 10 days postop. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pred Forte | Drug | Pred Forte BID for 4 weeks postop |
| |
| Lotemax |
| Measure | Description | Time Frame |
|---|---|---|
| Prevention Of Retinal Thickening |
| 1 Year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jenna Piel | Contact | (951)653-5566 | j.piel@imedsonline.com |
| Name | Affiliation | Role |
|---|---|---|
| William Trattler, MD | The Center for Excellence in Eye Care | Principal Investigator |
| John Hovanesian, MD | Harvard Eye Associates | Principal Investigator |
| Bonnie Henderson, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harvard Eye Associates | Recruiting | Laguna Hills | California | 92653 | United States |
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| Drug |
Lotemax BID for 4 weeks postop. |
|
| Ophthalmic Consultants of Boston |
| Principal Investigator |
| The Center For Excellence in Eye care | Recruiting | Miami | Florida | 33176 | United States |
|
| Ophthalmic Consultants of Boston | Completed | Waltham | Massachusetts | 02451 | United States |
| ID | Term |
|---|---|
| D019591 | Pseudophakia |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C009935 | prednisolone acetate |
| D000069559 | Loteprednol Etabonate |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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