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

This study has been withdrawn prior to enrollment.
(Nexis Vision was unable to provide the shields to continue with the study.)
Sponsor:
Collaborator:
Nexisvision
Information provided by (Responsible Party):
Durrie Vision
ClinicalTrials.gov Identifier:
NCT01706237
First received: October 11, 2012
Last updated: June 3, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Myopia
Device: Nexisvision shield
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation Of Visual Outcomes And Contrast Sensitivity After Myopic Wavefront-Optimized Lasik With Nexisvision Shield Or Bandage Contact Lens

Resource links provided by NLM:


Further study details as provided by Durrie Vision:

Primary Outcome Measures:
  • Visual Acuity over time [ Time Frame: Immediate, 30 minutes, 1 hour, 2 hour, and 4 hours ] [ Designated as safety issue: No ]
    Progress of the change in visual acuity will be measured at specific time intervals directly after LASIK surgery.

  • Contrast Sensitivity [ Time Frame: Immediate, 30 minutes, 1 hour, 2 hour, and 4 hours ] [ Designated as safety issue: No ]
    Change in contrast sensitivity compared to baseline will be documented at specific time intervals beginning immediately after LASIK surgery.


Enrollment: 0
Study Start Date: May 2012
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01706237

Sponsors and Collaborators
Durrie Vision
Nexisvision
Investigators
Principal Investigator: Daniel S Durrie, MD Durrie Vision
Principal Investigator: Stephen G. Slade, MD Slade & Baker Vision
  More Information

No publications provided

Responsible Party: Durrie Vision
ClinicalTrials.gov Identifier: NCT01706237     History of Changes
Other Study ID Numbers: NVS-SOVR-001
Study First Received: October 11, 2012
Last Updated: June 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Durrie Vision:
Myopia
LASIK

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on August 28, 2014