An Evaluation of Outcomes Following Wavefront Optimized or Wavefront Guided Lasik Procedure in Low to Moderate Myopic Patients

Myopia Clinical Trial

Official title:

A Prospective Evaluation of Outcomes Following Wavefront Optimized or Wavefront Guided Lasik Procedure in Low to Moderate Myopic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01173198
• Other study ID #: WFG-002-WFO
• Status: Completed
• Phase: Phase 4
• First received: February 1, 2010
• Last updated: June 13, 2012
• Start date: November 2009
• Est. completion date: May 2012

Study information

• Verified date: June 2012
• Source: Innovative Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

To compare post-surgical outcomes in patients who have undergone Wavefront Guided LASIK (iLASIK platform) compared with patients who have undergone Wavefront Optimized LASIK (Wavelight Allegretto 400 Hz platform).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 35 Years

Eligibility

Inclusion Criteria:

• The subject must be male or female, of any race, and at least 21 years old and not older than 35 years old at the time of the pre-operative examination;

• Both eyes must have a BSCVA of 20/20 or better;

• Both eyes must have a manifest refractive error from -2.00 D to -6.00 D, a cylinder component up to -1.50 D, and a maximum manifest spherical equivalent of -6.00 D;

• Both eyes must have at least 0.2 microns RMS HOA

• Both eyes must have a minimum pupil size of at least 6.0mm in dim illumination on wavescan;

• Both eyes must demonstrate refractive stability confirmed by clinical records or previous glasses. Refractive stability shall be documented by a change of less than or equal to 0.50 diopter (sphere and cylinder) at an exam at least 12 months prior to the baseline examination. The astigmatic axis must also be within 15 degrees for eyes with cylinder greater than 0.50 D; and

• Subjects should be willing and capable of returning for follow-up examinations for the duration of the study.

Exclusion Criteria:

• Use of systemic or ocular medications that may affect vision

• Subjects who use concurrent topical or systemic medications that may impair healing, including but not limited to: antimetabolites, isotretinoin (Accutane®) within 6 months of treatment, and amiodarone hydrochloride (Cordarone®) within 12 months of treatment; NOTE: The use of topical or systemic corticosteroids, whether chronic or acute, is deemed to adversely affect healing and subjects using such medication are specifically excluded from eligibility.

• Subjects with a history of any of the following medical conditions, or any other condition that could affect wound healing: 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; NOTE: The presence of diabetes (either type 1 or 2), regardless of disease duration, severity or control, will specifically exclude subjects from eligibility.

• The subject must not have 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 with evidence of glaucoma or propensity for narrow angle glaucoma in either eye; NOTE: This includes any subject with open angle glaucoma, regardless of medication regimen or control.

• Subjects who have Amblyopia or strabismus

• Subjects with known pathology that may affect visual acuity; particularly retinal changes that affect vision (macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, etc.)

• Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration, or other retinal disorders) that are predicted to cause future acuity losses to a level of 20/30 or worse

• Subjects who may be expected to require retinal laser treatment or other surgical intervention

• Subjects with pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate at least 4.0 mm under mesopic/scotopic conditions)

• Contact lens usage within 6 months for PMMA contacts lenses, 1 month for gas permeable lenses or 1 week for extended-wear and daily-wear soft contact lenses

• Subject must not have any evidence of keratoconus, corneal irregularity, or abnormal videokeratography in either eye;

• Subjects with known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course;

• Patients who cannot obtain a Wavescan capture; and

• patients seeking monovision.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• WAVEFRONT Optimized LASIK
30 patients
• WAVEFRONT GUIDED LASIK
30 patients

Locations

Country	Name	City	State
United States	Midwest Eye Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Innovative Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction or elimination of myopia and myopic astigmatism		12 months	No