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A Prospective Safety and Effectiveness Study of the 500 Hz Technolas Perfect Vision Excimer Laser Using LASIK

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: NCT02071576
Recruitment Status : Unknown
Verified November 2014 by Technolas Perfect Vision GmbH.
Recruitment status was:  Recruiting
First Posted : February 26, 2014
Last Update Posted : November 20, 2014
Sponsor:
Information provided by (Responsible Party):
Technolas Perfect Vision GmbH

Tracking Information
First Submitted Date  ICMJE January 30, 2014
First Posted Date  ICMJE February 26, 2014
Last Update Posted Date November 20, 2014
Study Start Date  ICMJE February 2014
Estimated Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 21, 2014)
The percentage of treated eyes within +/- 0.50D of target refraction [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
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 A Prospective Safety and Effectiveness Study of the 500 Hz Technolas Perfect Vision Excimer Laser Using LASIK
Official Title  ICMJE A Prospective Safety and Effectiveness Study of the 500 Hz Technolas Perfect Vision Excimer Laser Using LASIK
Brief Summary This clinical study has been planned to evaluate the safety and effectiveness of a common treatment algorithms (Proscan) using 500 Hz laser repetition rate.
Detailed Description This clinical study has been planned to evaluate the safety and effectiveness of the excimer laser treatment algorithm Proscan of the 500 Hz laser system for ametropia when performed on the cornea of virgin eyes.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Myopia
  • Hyperopia
Intervention  ICMJE Device: Proscan
One device (500 Hz Excimer Laser - TENEO) with one intervention (Proscan)
Study Arms  ICMJE Experimental: Proscan
Ametropia Lasik treatment of virgin eyes
Intervention: Device: Proscan
Publications * Not Provided

*   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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 21, 2014)
42
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2016
Estimated Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects have to be at least 18 years of age.
  • Subjects have to be able to read, understand, and sign a statement of Informed Consent.
  • Subjects have to be willing and able to return for scheduled follow-up examinations for up to 6 and 12 months respectively after surgery.
  • Corneal topography should be qualified
  • High contrast, manifest, best spectacle-corrected distance visual acuity correctable binocular to at least 1.0 (Snellen 20/20 or 6/6) and monocular to at least 0.8 (Snellen 20/25 or 6/7.5). In case of a monocular surgery the eye which should not be treated must have a best corrected distance visual acuity of at least 0.8 (Snellen 20/25 or 6/7.5).
  • Mesopic pupil size measured with the Zywave II WaveFront Aberrometer must be < 7.0 mm and photopic pupil size measured with the Orbscan II/ IIz must be > 2.9 mm.
  • Myopic subjects require a sphere between -0.5 D up to -10.0 D and cylinder between -0.5 D up to -4.0 D (not corneal astigmatism) and SE up to -12.0 D
  • Hyperopic subjects require a sphere between +0.5 D up to +4.0 D and cylinder between +0.5 D up to +4.0 D (not corneal astigmatism) and SE up to +6.0 D.

Exclusion Criteria:

  • Subjects for whom the combination of their baseline corneal thickness and the planned operative parameters for the LASIK procedure would result in less than 250 microns of remaining posterior corneal thickness below the flap postoperatively.
  • Hyperopic eyes for which the baseline manifest subjective refraction exhibits a difference of greater than ± 0.75 D in sphere power, or a difference of greater than ± 0.50 D in cylinder power, or a difference in cylinder axis of more than 15 degrees compared to the baseline cycloplegic subjective refraction. For manifest cylinder of less than ±0.75 D, the differ-ence in cylinder axis would not be taken into consideration.
  • Subjects with anterior segment pathology, including dry eye syndrome and cataracts, which in the Investigator's opinion would interfere with best spectacle-corrected visual acuity or a successful treatment.
  • Subjects with evidence of retinal vascular disease. Subjects with any residual, recurrent, or active ocular disease, or corneal abnormality that in the Investigator's opinion would interfere with BSCVA or a successful treatment.
  • Subjects with signs of keratoconus or Subjects with unstable central keratometry readings with irregular mires.
  • Subjects who had previous intraocular or corneal surgery of any kind, including any type of Excimer laser surgery for either refractive or therapeutic purposes.
  • Subjects who have a history of Herpes simplex or Herpes zoster keratitis or history of glaucoma or glaucoma suspect, corneal edema, or increased IOP > 22mmHg or risk for angle closure.
  • Subjects immunocompromised or carrying diagnosis of connective tissue disease, clinically significant atopic disease, diabetes, autoimmune diseases and other acute or chronic illnesses that will increase the risk to the subject or confound the outcomes of this study.
  • Subject taking systemic medications likely to affect wound healing such as corticosteroids or antimetabolites.
  • Subjects who are known to be pregnant, lactating, or who plans to become pregnant over the course of the study.
  • Subjects with an ocular muscle disorder including a strabismus or nystagmus, or other disorders affecting fixation.
  • Subjects with cognitive impairments or other vulnerable persons.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02071576
Other Study ID Numbers  ICMJE 1215
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Technolas Perfect Vision GmbH
Study Sponsor  ICMJE Technolas Perfect Vision GmbH
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Victor Woo, MD Hong Kong Laser Eye Centre
PRS Account Technolas Perfect Vision GmbH
Verification Date November 2014

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