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Evaluation of the Accuracy and Safety of the LaserArcs Femtosecond Cataract Surgery Arcuate Incision Nomogram in Patients Undergoing Cataract Surgery and Astigmatism Reduction
Femtosecond lasers allow the precise placement of arcuate keratotomy incisions in patients undergoing cataract surgery. Though these surgical devices have been available for several years, most current nomograms designed to reduce astigmatism with these incisions are derived from those developed for metal or diamond knives. Anecdotal reports from surgeons indicate that the previous nomograms have limited accuracy in the setting of femtosecond laser surgery.
LaserArcs.com is an online arcuate incision nomogram calculator initially developed on the basis of 12 months of data tabulation of patients undergoing femtosecond surgery with arcuate incisions. since that time, its user base has grown because of the high accuracy its model provides. Currently over 3500 calculations are performed each month on this platform.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LaserArc | Other | LaserArcs.com is an online arcuate incision nomogram calculator initially developed on the basis of 12 months of data tabulation of patients undergoing femtosecond surgery with arcuate incisions |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Endpoint -Postoperative magnitude of manifest astigmatism (diopters) divided by preoperative magnitude of manifest astigmatism (diopters) | Percent change in absolute magnitude of astigmatism | Up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Attempted vs Achieved Correction (see description) | Mean attempted vs achieved correction. Attempted correction=postop target astigmatism-pre-op corneal astigmatism), achieved correction=postop manifest cylinder-pre-op corneal astigmatism, attempted vs achieved=achieved correction-attempted correction mean attempted vs achieved=average of all individual calculated values for attempted vs achieved correction |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory Endpoint - Postoperative manifest refraction cylinder and axis is the measured magnitude of spherical and cylindrical refraction at the postoperative visit. | Postoperative manifest refraction for sphere, cylinder, and axis. | Up to 3 months |
Inclusion Criteria:
Exclusion Criteria:
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The study aims to enroll 50 patients that had previous cataract surgery performed with femtosecond lasers.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quantum Vision Centers | Belleville | Illinois | 62226 | United States |
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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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| Up to 3 months |
| Secondary Endpoint - Standard deviation of attempted vs achieved correction = standard deviation of of all individual calculated values for attempted vs achieved correction | Standard deviation of attempted vs number of achieved correction of corneal astigmatism. | Up to 3 months |