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To determine clinically significant difference in results obtained from cataract surgery using IA. One eye will receive aphakic measurements only and the fellow eye will receive aphakic and then pseudophakic measurements when implanting a toric IOL.
To determine if there is a clinically significant difference in the results obtained for the toric IOL implantation when using IA to measure the aphakic eye only and when using IA to measure the aphakic eye and then the pseudophakic eye, with toric IOL implantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aphakic Measure only | No Intervention | Eye measured in aphakic state only | |
| Pseudophakic measure | Active Comparator | Eye measured in aphakic state then again in pseudophakic state with toric IOL using the ORA System. Pseudophakic measurement obtained will provide data about placement of toric iol and the surgeon will use that data to rotate the iol if necessary. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pseudophakic Measurement | Diagnostic Test | standard aphakic measurements will be taken and then pseudophakic measurements will be taken after toric iol implantation. The data produced will aid the surgeon in proper placement of toric iol orientation |
| Measure | Description | Time Frame |
|---|---|---|
| Clinically significant difference in results obtained for tori iol implantation when using IA | Difference in magnitude of residual refractive astigmatism between groups Percentage of eyes with 0.50D or less of postoperative residual refractive astigmatism at 1 month post-op in each sub-group
| 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alterman Modi and Wolter Ophthalmic Physicians and Surgeons | Poughkeepsie | New York | 12603 | United States |
Results of the study may be shared at international meetings and submitted for peer review
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| ID | Term |
|---|---|
| D002386 | Cataract |
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D012030 | Refractive Errors |
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