Evaluation of Outcomes Using the AMO Advanced Customvue™ iLasik Procedure

This study has been completed.
Sponsor:
Information provided by:
Innovative Medical
ClinicalTrials.gov Identifier:
NCT01061294
First received: February 1, 2010
Last updated: January 12, 2011
Last verified: January 2011
  Purpose

The purpose of this study is to assess the efficacy, predictability and safety of the Advanced CustomVue™ iLASIK procedure (WaveScan WaveFront® System, STAR S4 IR™ Excimer Laser System and IntraLase™ FS System). Patient data will be collected electronically and analyzed to determine improvements in postoperative visual acuity, visual quality and residual error.


Condition Intervention Phase
Vision Correction
Procedure: Advanced CustomVue™ iLASIK procedure
Device: WaveScan WaveFront® System, STAR S4 IR™ Excimer Laser System and IntraLase™ FS System
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Outcomes Using the AMO Advanced Customvue™ iLasik Procedure (Wavescan Wavefront® System, Star S4 IR™ Excimer Laser System and Intralse™ FS System)

Further study details as provided by Innovative Medical:

Primary Outcome Measures:
  • Postoperative visit procedures will include visual acuity and quality assessments and monitoring for surgical complications necessitating retreatment. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: December 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Advanced CustomVue™ iLASIK procedure Procedure: Advanced CustomVue™ iLASIK procedure Device: WaveScan WaveFront® System, STAR S4 IR™ Excimer Laser System and IntraLase™ FS System

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. the subject must be male or female, of any race, and at least 21 years old at the time of the pre-operative examination;
  2. both eyes must have a BSCVA of 20/20 or better;
  3. both eyes must have a manifest refractive error from -0.50 D to -6.00 D, a cylinder component up to -3.00 D, and a maximum manifest spherical equivalent of -6.00 D;
  4. both eyes must have a minimum pupil size of at least 6.0mm in dim illumination on wavescan;
  5. 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
  6. subjects should be willing and capable of returning for follow-up examinations for the duration of the study.

Exclusion Criteria:

  1. 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.
  2. 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.
  3. 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. .
  4. the subject must not have any evidence of keratoconus, corneal irregularity, or abnormal videokeratography in either eye;
  5. subjects with known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course;
  6. patients who do not achieve Iris registration at the time of their wavescan; and
  7. patients seeking monovision.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01061294

Locations
United States, Florida
William Trattler
Miami, Florida, United States, 33176
Sponsors and Collaborators
Innovative Medical
  More Information

No publications provided

Responsible Party: William Trattler, The Center for Excellence in Eye Care
ClinicalTrials.gov Identifier: NCT01061294     History of Changes
Other Study ID Numbers: iLASIK
Study First Received: February 1, 2010
Last Updated: January 12, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Innovative Medical:
Assess the efficacy, predictability and safety of the Advanced CustomVue™ iLASIK procedure.

ClinicalTrials.gov processed this record on July 22, 2014