NCT01061294

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2009

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 3, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

January 13, 2011

Status Verified

January 1, 2011

Enrollment Period

1 year

First QC Date

February 1, 2010

Last Update Submit

January 12, 2011

Conditions

Vision Correction

Keywords

Assess the efficacy, predictability and safety of the Advanced CustomVue™ iLASIK procedure.

Outcome Measures

Primary Outcomes (1)

  • Postoperative visit procedures will include visual acuity and quality assessments and monitoring for surgical complications necessitating retreatment.

    1 year

Study Arms (1)

Advanced CustomVue™ iLASIK procedure

OTHER
Procedure: Advanced CustomVue™ iLASIK procedureDevice: WaveScan WaveFront® System, STAR S4 IR™ Excimer Laser System and IntraLase™ FS System

Interventions

Advanced CustomVue™ iLASIK procedurePROCEDURE
Advanced CustomVue™ iLASIK procedure
WaveScan WaveFront® System, STAR S4 IR™ Excimer Laser System and IntraLase™ FS SystemDEVICE
Advanced CustomVue™ iLASIK procedure

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • the subject must be male or female, of any race, and at least 21 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 -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;
  • 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.

You may not qualify if:

  • 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. .
  • the 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 do not achieve Iris registration at the time of their wavescan; and
  • patients seeking monovision.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

William Trattler

Miami, Florida, 33176, United States

Location

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 1, 2010

First Posted

February 3, 2010

Study Start

December 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

January 13, 2011

Record last verified: 2011-01

Locations

US(1)