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Nexis Vision was unable to provide the shields to continue with the study.
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| Name | Class |
|---|---|
| Nexisvision | UNKNOWN |
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Evaluate visual outcomes and contrast sensitivity for subjects undergoing bilateral myopic LASIK with a Nexisvision Shield or bandage contact lens placed postoperatively. Early speed of visual recovery results indicate that the visual recovery in the first 4 hours after the LASIK procedure show the most variability. A patient's ability to drive after their LASIK procedure would potentially alleviate a challenge that patients often face in taking additional time off work or simply finding a ride to there LASIK procedure.
Laser in situ keratomileusis (LASIK) surgery has been performed worldwide since 1990. Historically, LASIK has been reported to decrease contrast sensitivity post operatively and patients have been advised to take the day off of work and potentially the day after LASIK. More recently, utilizing advanced laser technology for optimized corneal ablation and creation of the flap has the potential for improved LASIK surgery results and improved recovery time. Visual recovery and management of immediate post operative visual acuity is important for patient satisfaction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Shield | Experimental | A shield (similar to a contact lens) is placed on the eye after myopic LASIK procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nexisvision shield | Device | A shield is placed on the eye after LASIK. The shield is similar to a contact lens. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity over time | Progress of the change in visual acuity will be measured at specific time intervals directly after LASIK surgery. | Immediate, 30 minutes, 1 hour, 2 hour, and 4 hours |
| Contrast Sensitivity | Change in contrast sensitivity compared to baseline will be documented at specific time intervals beginning immediately after LASIK surgery. | Immediate, 30 minutes, 1 hour, 2 hour, and 4 hours |
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INCLUSION CRITERIA:
EXCLUSION CRITERIA:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel S Durrie, MD | Durrie Vision | Principal Investigator |
| Stephen G. Slade, MD | Slade & Baker Vision | Principal Investigator |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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