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Withdrawn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
About this trial
This is an interventional treatment trial for Myopia focused on measuring Myopia, LASIK
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.
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
NCT ID
NCT01706237
First Posted
October 11, 2012
Last Updated
June 3, 2014
Sponsor
Durrie Vision
Collaborators
Nexisvision
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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