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Study terminated due to insufficient subject participation
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In this study, the investigators plan to compare the incidence and complications of intraoperative floppy iris syndrome (IFIS) during cataract surgery in patients taking tamsulosin (Flomax) and treated with retrobulbar injection of anesthesia, versus injection of Healon 5 viscoelastic into the anterior chamber.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Healon 5 |
|
| 2 | Experimental | Retrobulbar Anesthetic Injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Healon 5 injection | Procedure | Healon 5 (2.3% Sodium hyaluronate) ophthalmic viscoelastic device will be injected into the anterior chamber as needed for pupillary dilation and adequate cataract extraction with intraocular lens placement. |
| Measure | Description | Time Frame |
|---|---|---|
| Pupil diameter after hydrodissection | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Pupil diameter after nuclear removal | 2 years | |
| Pupil diameter after cortex removal | 2 years | |
| Pupil diameter at conclusion of surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ahmad A Aref, M.D. | The Penn State Hershey Eye Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State Hershey Eye Center | Hershey | Pennsylvania | 17036 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17467530 | Background | Chang DF, Osher RH, Wang L, Koch DD. Prospective multicenter evaluation of cataract surgery in patients taking tamsulosin (Flomax). Ophthalmology. 2007 May;114(5):957-64. doi: 10.1016/j.ophtha.2007.01.011. |
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| Retrobulbar anesthetic injection | Procedure | 3-4cc of anesthetic (1% lidocaine/0.75% bupivicaine) will be injected with a 25 gauge needle into the extraocular muscle cone prior to patient and microscope positioning. Cataract extraction with intraocular lens placement will then proceed in standard fashion. |
|
| 2 years |