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Peripheral PresbyLASIK Using the Allegretto Wavelight System For The Treatment of Presbyopia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01059006
Recruitment Status : Withdrawn (Lead researcher completed fellowship and never got study off ground)
First Posted : January 29, 2010
Last Update Posted : August 5, 2011
Sponsor:
Information provided by:
University of California, San Diego

Tracking Information
First Submitted Date  ICMJE January 28, 2010
First Posted Date  ICMJE January 29, 2010
Last Update Posted Date August 5, 2011
Study Start Date  ICMJE January 2010
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 28, 2010)
  • Uncorrected near visual acuity [ Time Frame: 1 Day, 1 Week, 3 and 6 Months ]
  • Best corrected near visual acuity [ Time Frame: 1 Day, 1 Week, 3 and 6 Months ]
  • Intermediate visual acuity [ Time Frame: 1 Day, 1 Week, 3 and 6 Months ]
  • Stereoacuity test [ Time Frame: 1 Day, 1 Week, 3 and 6 Months ]
  • Psychometric questionnaire [ Time Frame: 1 Day, 1 Week, 3 and 6 Months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01059006 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Peripheral PresbyLASIK Using the Allegretto Wavelight System For The Treatment of Presbyopia
Official Title  ICMJE Peripheral PresbyLASIK Using the Allegretto Wavelight System For The Treatment of Presbyopia
Brief Summary The aim of this study is to analyze the results of PresbyLASIK performed using the wavefront-optimized LASIK for the treatment of presbyopia on low hyperopic and low myopic patients with astigmatism. Visual performance will be assessed using clinical outcome measures of the following: refraction, near, intermediate and distance visual acuity, stereoacuity and contrast sensitivity. Questionnaires will also be used to evaluate how the patient's vision is before and after surgery.
Detailed Description

Presbyopia is a physiologic change related to age in which there is reduction in the eye's ability to focus in order to obtain clear vision for near distance. At approximately age 40 the range of accommodation begins to decrease and there is a diminishing capacity of the eye to focus on the nearest point it can focus on. This makes the need for corrective lenses a necessity in order to read at near as well as focus at an intermediate distance.

Presbyopia correction is one of the most frequently discussed topics in refractive surgery today. The idea of a creating a multifocal cornea using refractive surgery has sparked tremendous interest in finding a solution for this growing population throughout the world, especially amongst surgeons and the ophthalmic industry

PresbyLASIK essentially involves the creation of a multifocal surface able to correct any visual defect for distance while simultaneously allowing freedom from near spectacle dependency in presbyopic patients. PresbyLASIK is currently being offered routinely to patients in the San Diego area, across the country as well as in numerous centers around the world.

Conclusions from this study would serve as a guide for keratorefractive surgeons, who are pursuing peripheral PresbyLASIK, in determining the preoperative patient features in order to achieve the best outcome using the Wavelight-Allegretto System.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Refractive Error
  • Presbyopia
Intervention  ICMJE Procedure: PresbyLASIK
PresbyLASIK essentially involves the creation of a multifocal surface able to correct any visual defect for distance while simultaneously allowing freedom from near spectacle dependency in presbyopic patients.
Other Names:
  • Presbyopia
  • Presbyopic Symptoms
Study Arms  ICMJE Experimental: PresbyLASIK
Male or female patients with presbyopic symptoms who underwent PresbyLASIK.
Intervention: Procedure: PresbyLASIK
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: November 22, 2010)
0
Original Estimated Enrollment  ICMJE
 (submitted: January 28, 2010)
100
Actual Study Completion Date  ICMJE July 2010
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female, of any race, and at least 35 to 80 years old with significant presbyopic symptoms at the time of the preoperative examination, and have signed an informed consent. The lower age limit of 35 is the earliest age in which reduction in accommodation occurs.
  • Refractive error between +3.00 to -5.00 diopters (D) sphere at the spectacle plane with no more than 3.00D of refractive astigmatism (negative cylinder format)
  • Best spectacle corrected visual acuity of at least 20/20 and J3 in both eyes.
  • Residual corneal bed thickness of ≥ to 330 microns
  • Demonstrated refractive stability, confirmed by clinical records. Neither the spherical nor the cylindrical portion of the refraction may have changed more than 0.50D during the 12-month period immediately preceding the baseline examination.
  • Soft contact lens users must have removed their lenses at least one week before baseline measurements. Hard contact lens users (PMMA or rigid gas permeable lenses) must have removed their lenses at least 4 weeks prior to baseline measurements and have two central keratometry readings and two manifest refractions taken at least one week apart that do not differ by more than 0.50 diopter in either meridian; mires should be regular.
  • Located in the greater San Diego area for a 6-month period.
  • Exhibit strong motivation for attending the follow-up visits.
  • Access to transportation to meet follow-up requirements.

Exclusion Criteria:

  • Patients that have previously been treated for refractive surgery (LASIK and/or PRK)
  • Patients with known history or have concurrent dry eye disease (e.g. keratoconjunctivitis sicca)
  • Patients who have less than 5 mm pupil size in dimlight
  • Female subjects who are pregnant, breast-feeding or intend to become pregnant during the first six months of the study.
  • Concurrent topical or systemic medications that may impair healing, including corticosteroids, antimetabolites, isotretinoin (Accutane), amiodarone hydrochloride (Cordarone) and/or sumatriptan (Imitrex) or any other triptan.
  • Medical condition(s), which, in the judgment of the investigator, may impair healing, including but not limited to: collagen vascular disease, autoimmune disease, immunodeficiency diseases, and ocular herpes zoster or simplex.
  • Active ophthalmic disease, neovascularization of the cornea within 1mm of the intended ablation zone, or lens opacity.
  • Evidence of glaucoma or an intraocular pressure greater than 22 mm Hg at baseline.
  • Evidence of keratoconus, corneal irregularity, or abnormal videokeratography in either eye.
  • Corneal thickness insufficient to allow the residual remaining stromal bed to be at least 300 microns in each eye. The residual stromal bed thickness will be determined by subtracting both the LASIK flap thickness and depth of the ablation from the total central corneal thickness measured by pachymetry
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT01059006
Other Study ID Numbers  ICMJE 091460
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David Schanzlin, MD, UCSD Shiley Eye Center
Study Sponsor  ICMJE University of California, San Diego
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David J Schanzlin, MD UCSD Shiley Eye Center
PRS Account University of California, San Diego
Verification Date August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP