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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01706237
• Other study ID #: NVS-SOVR-001
• Status: Withdrawn
• Phase: Phase 4
• First received: October 11, 2012
• Last updated: June 3, 2014
• Start date: May 2012

Study information

• Verified date: June 2014
• Source: Durrie Vision
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Nexisvision shield
A shield is placed on the eye after LASIK. The shield is similar to a contact lens.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Durrie Vision	Nexisvision

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No