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

Therapuetic Areas:Ophthalmology
Age Range:Any
Start Date:May 2012
Contact:Brigette L Ellis, BSE

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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.

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.


- 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

- 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.


- 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

- 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

- 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.
We found this trial at
Overland Park, Kansas 66211
Overland Park, KS
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Austin, Texas 77027
Austin, TX
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