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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Myopia
• Intervention / Treatment: Device: Nexisvision shield

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 Type: Interventional
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

INCLUSION CRITERIA:

• Male or female in good general health, 18 years of age or older at the time of the pre-operative examination
• Patient must be able to read, comprehend and willing to give HIPPA and informed consent
• Patient is planning to undergo a bilateral LASIK procedure
• Both eyes must have a manifest refractive error from -1.00 D to -7.00 spherical equivalent with less than or equal to 3.00D of refractive astigmatism as expressed in spectacle minus cylinder form
• Both eyes must have a BSCVA of 20/20 or better
• Both eyes must demonstrate refractive stability confirmed by clinical records, previous glasses, or investigator's discretion.
• Patient must be willing to comply with study dosing and complete the entire course of the study.

EXCLUSION CRITERIA:

• A patient with evidence of keratoconus, corneal irregularity, or abnormal videokeratography in either eye
• A patient seeking monovision
• A patient with a known hypersensitivity to any of the components of the procedural or post-LASIK medications
• A patient requiring the use of any ocular drop(s) and/or medication(s) in either eye during the study period with the exception of ocular drops and/or medications provided by the investigator
• A patient having any surgical procedure within a week preceding the scheduled LASIK surgery
• A patient with any UNCONTROLLED systemic disease (i.e., a potential patient in whom therapy for a systemic disease is not yet stabilized )
• A patient with a history of prior intraocular or corneal surgery (including cataract extraction), active ophthalmic disease or abnormality (including, but not limited to, blepharitis, recurrent corneal erosion, dry eye syndrome, neovascularization > 1mm from limbus), clinically significant lens opacity, clinical evidence of trauma (including scarring), or evidence of glaucoma or propensity for narrow angle glaucoma in either eye
• A patient with a significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, may increase the risk associated with study participation or may interfere with the interpretation of study results
• A patient with a history of any of the following medical conditions, or any other condition that could affect wound healing: uncontrolled diabetes, collagen vascular disease, autoimmune disease, immunodeficiency diseases, ocular herpes zoster or simplex, endocrine disorders (including, but not limited to unstable thyroid disorders and diabetes), lupus, and rheumatoid arthritis
• Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Shield; A shield (similar to a contact lens) is placed on the eye after myopic LASIK procedure.	Device: Nexisvision shield; A shield is placed on the eye after LASIK. The shield is similar to a contact lens.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Durrie Vision
• Collaborators: Nexisvision
• Investigators: Principal Investigator: Daniel S Durrie, MD, Durrie Vision; Principal Investigator: Stephen G. Slade, MD, Slade & Baker Vision

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: October 11, 2012
• First Submitted That Met QC Criteria: October 12, 2012
• First Posted (Estimate): October 15, 2012

Study Record Updates

• Last Update Posted (Estimate): June 4, 2014
• Last Update Submitted That Met QC Criteria: June 3, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: Myopia; LASIK
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: NVS-SOVR-001