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

Primary Purpose

Myopia

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Nexisvision shield
Sponsored by
Durrie Vision
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia focused on measuring Myopia, LASIK

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Shield

    Arm Description

    A shield (similar to a contact lens) is placed on the eye after myopic LASIK procedure.

    Outcomes

    Primary Outcome Measures

    Visual Acuity over time
    Progress of the change in visual acuity will be measured at specific time intervals directly after LASIK surgery.
    Contrast Sensitivity
    Change in contrast sensitivity compared to baseline will be documented at specific time intervals beginning immediately after LASIK surgery.

    Secondary Outcome Measures

    Full Information

    First Posted
    October 11, 2012
    Last Updated
    June 3, 2014
    Sponsor
    Durrie Vision
    Collaborators
    Nexisvision
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01706237
    Brief Title
    Visual Outcomes And Contrast Sensitivity After Myopic Wavefront-Optimized Lasik With Nexisvision Shield Or Bandage Contact Lens
    Official Title
    Evaluation Of Visual Outcomes And Contrast Sensitivity After Myopic Wavefront-Optimized Lasik With Nexisvision Shield Or Bandage Contact Lens
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2014
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Nexis Vision was unable to provide the shields to continue with the study.
    Study Start Date
    May 2012 (undefined)
    Primary Completion Date
    June 2014 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Durrie Vision
    Collaborators
    Nexisvision

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myopia
    Keywords
    Myopia, LASIK

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Shield
    Arm Type
    Experimental
    Arm Description
    A shield (similar to a contact lens) is placed on the eye after myopic LASIK procedure.
    Intervention Type
    Device
    Intervention Name(s)
    Nexisvision shield
    Intervention Description
    A shield is placed on the eye after LASIK. The shield is similar to a contact lens.
    Primary Outcome Measure Information:
    Title
    Visual Acuity over time
    Description
    Progress of the change in visual acuity will be measured at specific time intervals directly after LASIK surgery.
    Time Frame
    Immediate, 30 minutes, 1 hour, 2 hour, and 4 hours
    Title
    Contrast Sensitivity
    Description
    Change in contrast sensitivity compared to baseline will be documented at specific time intervals beginning immediately after LASIK surgery.
    Time Frame
    Immediate, 30 minutes, 1 hour, 2 hour, and 4 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Daniel S Durrie, MD
    Organizational Affiliation
    Durrie Vision
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Stephen G. Slade, MD
    Organizational Affiliation
    Slade & Baker Vision
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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