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CompletedNCT01173198Updated Jun 14, 2012

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

A Phase 4 interventional study of WAVEFRONT Optimized LASIK and WAVEFRONT GUIDED LASIK in Myopia, sponsored by Innovative Medical. Completed at 1 site in United States. Open to participants aged 21 Years to 35 Years. Per ClinicalTrials.gov, last updated 2012-06-14.

Sponsored by Innovative Medical · Phase 4, Interventional, and Diagnostic

Phase
Phase 4
Study type
Interventional
Enrollment
37
Allocation
Non-randomized
Ages
21 Years to 35 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Myopia

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Keywords

  • LOW TO MODERATE MYOPIC PATIENTS
03

In context

Myopia

1,007 studies on the registry are indexed under Myopia; 210 are open to participants now.

This study's enrollment of 37 is below the median of 80 across 803 interventional studies indexed under Myopia.

Browse Myopia studies →

Lead sponsor

Innovative Medical is the lead sponsor of 51 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
37 participants (actual)

Study arms

  • Active comparator
    WAVEFRONT GUIDED LASIK

    Device: WAVEFRONT Optimized LASIK

  • Active comparator
    WAVEFRONT OPTIMIZED

    Device: WAVEFRONT GUIDED LASIK

Interventions

  • DeviceWAVEFRONT Optimized LASIK

    30 patients

  • DeviceWAVEFRONT GUIDED LASIK

    30 patients

06

What researchers measure

Primary outcomes

  1. Reduction or elimination of myopia and myopic astigmatism

    Time frame: 12 months

07

Study locations

1 site
  • Midwest Eye Center
    Cincinnati, Ohio 45246, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2009, a primary completion of May 2012 and a completion of May 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 1, 2010
First posted
Jul 30, 2010
Start
Nov 2009
Primary completionActual
May 2012
CompletionActual
May 2012
Last update
Jun 14, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 14, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01173198
Lead sponsor
Innovative Medical
First posted
Jul 30, 2010
Start date
Nov 2009
Primary completion
May 2012
Completion
May 2012
Last update
Jun 14, 2012

Study contacts

David Schneider, MD
principal investigator · MIdwest Eye Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.

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