Visual Outcomes And Contrast Sensitivity After Myopic Wavefront-Optimized Lasik With Nexisvision Shield Or Bandage Contact Lens

Phase 4

Withdrawn

• Conditions: Myopia
• Interventions: Device: Nexisvision shield

• Registration Number: NCT01706237
• Lead Sponsor: Durrie Vision

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-10-11
• Study First Submitted QC: 2012-10-12
• Study First Posted: 2012-10-15
• Status Verified: 2014-06
• Primary Completion: 2014-06
• Last Update Submitted: 2014-06-03
• Last Update Posted: 2014-06-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Shield	Nexisvision shield	A shield (similar to a contact lens) is placed on the eye after myopic LASIK procedure.

Primary Outcome Measures

Name	Time	Method
Visual Acuity over time	Immediate, 30 minutes, 1 hour, 2 hour, and 4 hours	Progress of the change in visual acuity will be measured at specific time intervals directly after LASIK surgery.
Contrast Sensitivity	Immediate, 30 minutes, 1 hour, 2 hour, and 4 hours	Change in contrast sensitivity compared to baseline will be documented at specific time intervals beginning immediately after LASIK surgery.