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Intrastromal Correction of Ametropia by a Femtosecond Laser (ISCAF)

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ClinicalTrials.gov Identifier: NCT00928122
Recruitment Status : Unknown
Verified February 2010 by 20/10 Perfect Vision.
Recruitment status was:  Recruiting
First Posted : June 25, 2009
Last Update Posted : February 9, 2010
Sponsor:
Information provided by:
20/10 Perfect Vision

Tracking Information
First Submitted Date  ICMJE June 3, 2009
First Posted Date  ICMJE June 25, 2009
Last Update Posted Date February 9, 2010
Study Start Date  ICMJE July 2008
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2009)
Prove safety and effectiveness as well as improvement in near visual acuity performance and increase in near visual acuity. [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2009)
  • Validate the 3 months results [ Time Frame: 6 months ]
  • Prove stability of distance visual acuity and safety of the procedure regarding infections and inflammatory response as well as corneal endothelial cell counts. [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intrastromal Correction of Ametropia by a Femtosecond Laser
Official Title  ICMJE Intrastromal Correction of Ametropia by a Femtosecond Laser
Brief Summary

This study evaluates the intrastromal correction of ametropia with a femtosecond laser made by 20/10 PERFECT VISION. This laser generates a beam of ultrashort, infrared pulses which enables very precise cuts in the cornea. By these cuts lamellae of the cornea are separated locally, and in the consequence the curvature of the cornea is changed, and the correction of the diagnosed ametropia can be achieved. On the contrary to cuts which are generated with a sharp knife, the cuts generated when using a laser can be generated just inside the cornea without opening the surface of the cornea. This means the procedure is minimal-invasive.

The study hypothesis is: Different types of ametropia can be corrected safely and on long-term by intrastromal cuts.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Presbyopia
  • Myopia
  • Hyperopia
  • Astigmatism
Intervention  ICMJE
  • Device: Intrastromal Correction of Presbyopia
    Applying defined, pre-programmed patterns (e.g. rings and/or radial cuts)into the human eye cornea. It is a minimal-invasive procedure which changes the topography of the cornea and by that the refraction ability.
    Other Names:
    • - FEMTEC Laser System
    • - Patient Interface
  • Device: Intrastromal correction of Myopia
    Applying defined, pre-programmed patterns (e.g. rings and/or radial cuts)into the human eye cornea. It is a minimal-invasive procedure which changes the topography of the cornea and by that the refraction ability.
    Other Name: FEMTEC Laser System
  • Device: Intrastromal Correction of Hyperopia
    Applying defined, pre-programmed patterns (e.g. rings and/or radial cuts)into the human eye cornea. It is a minimal-invasive procedure which changes the topography of the cornea and by that the refraction ability.
    Other Name: FEMTEC Laser System
  • Device: Intrastromal Correction of Myopia incl. Astigmatism
    Applying defined, pre-programmed patterns (e.g. rings and/or radial cuts)into the human eye cornea. It is a minimal-invasive procedure which changes the topography of the cornea and by that the refraction ability.
    Other Name: FEMTEC Laser System
  • Device: Intrastromal Correction of Hyperopia incl. Astigmatism
    Applying defined, pre-programmed patterns (e.g. rings and/or radial cuts)into the human eye cornea. It is a minimal-invasive procedure which changes the topography of the cornea and by that the refraction ability.
    Other Name: FEMTEC Laser System
Study Arms  ICMJE
  • Experimental: 1 / Presbyopia
    Presbyopic patients, slightly hyperopes
    Intervention: Device: Intrastromal Correction of Presbyopia
  • Experimental: 2 / Myopia
    Myopic patients without Astigmatism
    Intervention: Device: Intrastromal correction of Myopia
  • Experimental: 3 / Hyperopia
    Hyperope patients without Astigmatism
    Intervention: Device: Intrastromal Correction of Hyperopia
  • Experimental: 4 / Myopia with Astigmatism
    Myopic patients incl. Astigmatism
    Intervention: Device: Intrastromal Correction of Myopia incl. Astigmatism
  • Experimental: 5 / Hyperopia with Astigmatism
    Hyperope patients incl. Astigmatism
    Intervention: Device: Intrastromal Correction of Hyperopia incl. Astigmatism
Publications * Khoramnia R, Fitting A, Rabsilber TM, Thomas BC, Auffarth GU, Holzer MP. Intrastromal femtosecond laser surgical compensation of presbyopia with six intrastromal ring cuts: 3-year results. Br J Ophthalmol. 2015 Feb;99(2):170-6. doi: 10.1136/bjophthalmol-2014-305642. Epub 2014 Sep 2.

*   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: June 24, 2009)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2012
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • age: > 18 years
  • stable distance refraction for at least one year (i.e. a maximum change of 0.5 D)
  • in the case of presbyopia: minimum near add +2D to + 4D
  • in the case of myopia or hyperopia (without astigmatism): minimal 1D and maximum 3D
  • in the case of myopia or hyperopia (with astigmatism): spherical equivalent of minimal 1D and maximum 3D
  • BSCVA of the eye to be treated >= 0.63
  • patients are willing and in such conditions to come to the follow-up exams
  • no further ocular pathologies

Exclusion Criteria:

  • age: < 18 years
  • refraction less than +/- 1 D or higher than +/- 3 D (not valid for presbyopia patients)
  • minimal pachymetry of < 500µm
  • K-mean < 37 D or > 60 D
  • Difference (K-max minus K-min) > 5D
  • Difference cycloplegic refraction to subjective refraction more than 1 D (valid only for hyperopia correction)
  • patients with previous intraocular or corneal surgeries (e.g. post-LASIK or PRK patients). Exemption: standard cataract surgery.
  • patients with one or more of the following ocular pathologies:

    • keratokonus
    • corneal scars
    • transplanted cornea
    • disorders of wound healing
    • trauma
    • glaucoma
    • epilepsia
    • nystagmus
    • lack of concentration
    • other complicated illnesses
    • diabetes mellitus
    • instable K-readings as a sign of instable cornea
    • weakness of connective tissue
    • sensitivity against the drugs used in the study
    • continuous wearing of contact lenses before the pre-exam, and before the surgery. At least 14 days before these dates patients must abstain from wearing CL.
    • patients in pregnancy or during lactation
    • patients who take part in another clinical trial
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00928122
Other Study ID Numbers  ICMJE ISCAF
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Priv.-Doz. Dr. med. Mike P. Holzer, Universitaets-Augenklinik Heidelberg
Study Sponsor  ICMJE 20/10 Perfect Vision
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gerd U. Auffarth, Prof. Dr. Universitäts-Augenklinik Heidelberg
PRS Account 20/10 Perfect Vision
Verification Date February 2010

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