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The purpose of this study is to compare the efficacy and side effects of topical Loteprendol etabonate 0.5% (Lotemax) versus Dexamethasone 0.1% (Sterodex) following strabismus surgery.
This is a randomized prospective study that will involve 100 patients (males and females) undergoing strabismus surgery. All patients will be randomly assigned to receive one of the study drugs (Loteprendol etabonate 0.5% (Lotemax) drops or Dexamethasone 0.1% (Sterodex) drops) after undergoing strabismus surgery. In addition to the study drug all patients (in both groups) will receive topical Ofloxacin 0.3% (Oflox) eye drops. All patients will undergo a complete ophthalmological evaluation before surgery including orthoptic assessment of their strabismus and measurement of intraocular pressure (IOP). Topical treatment with the study drug and topical Ofloxacin 0.3% (Oflox) eye drops will begin on the evening of the surgery, following a schedule that will be the same for both groups: 4 times daily during the first week, 3 times daily for the second group, twice daily for the third week, and as needed for the fourth week. All patients will be examined at 1 day, 1 week, 2 weeks and 4 weeks after surgery by a masked investigator (not the strabismus surgeon).
The parameters to be checked will include:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Loteprendol | Experimental | Topical Loteprendol used after strabismus surgery |
|
| Dexamethasone | Experimental | Topical Dexamethasone used after strabismus surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Loteprendol etabonate 0.5% | Drug | Steroid eye drops used after strabismus surgery. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline - Intraocular pressure (IOP) | IOP will be measured by Goldmann applantation tonometry one day before surgery (baseline IOP). In patients in whom Goldmann tonometry is impossible, ICARE tonometer will be used instead. IOP will be measured 1 day, 1 week, 2 weeks, 4 weeks after surgery, at each time point change from baseline IOP will be recorded. | 1 day before surgery (basline), and 1 day, 1 week, 2 weeks, 4 weeks after surgery |
| Change from baseline - Conjunctival hyperemia | Conjunctival hyepremia will be measured one day before surgery (basline measurement) using the following scale: 0=no hyperemia, 1=mild (less than one quadrant), 2=moderate (less than half of the conjunctival surface), 3= severe (less than half of the conjunctival surface). Conjunctival hyperemia will be measured 1 day, 1 week, 2 weeks, 4 weeks after surgery, at each time point change from baseline measurement will be recorded. | 1 day before surgery (basline), and 1 day, 1 week, 2 weeks, 4 weeks after surgery |
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Inclusion Criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Ophthalmology, Tel Aviv Sourasky Medical Center | Tel Aviv | 64239 | Israel |
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| Dexamethasone 0.1% |
| Drug |
|