Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Prospective Evaluation of the Effectiveness of the Femtosecond Laser-assisted Refractive Astigmatic Keratotomy.

This study has been completed.
Information provided by (Responsible Party):
Technolas Perfect Vision GmbH Identifier:
First received: June 11, 2013
Last updated: May 30, 2014
Last verified: May 2014
This clinical phase IV study is an open, prospective phase IV study and acts to evaluate the effectiveness of the femtolaser-assisted astigmatic keratotomy.

Condition Intervention Phase
Device: Laser-assisted Astigmatic keratotomy
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase IV Study_Prospective Evaluation of the Effectiveness of the Femtosecond Laser-assisted Refractive Astigmatic Keratotomy Following the Cataract Surgery.

Further study details as provided by Technolas Perfect Vision GmbH:

Primary Outcome Measures:
  • Keratomic corneal astigmatism [ Time Frame: The study endpoints will be calculated for the 3-Months follow-up examination. ]
    The postoperative keratomic corneal astigmatism is in 60% of all eyes equal or better than 1.0D

Secondary Outcome Measures:
  • Topographic corneal and subjective cylinder [ Time Frame: This end point is measured at the 3 Months Follow Up. ]
    • The postoperative astigmatism in topography is in 60% of all eyes equal or better than 1.0D
    • The postoperative subjective astigmatism in manifest refraction is in 60% of all eyes equal or better than 1D.

Enrollment: 45
Study Start Date: January 2013
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Astigmatic keratotomy Device: Laser-assisted Astigmatic keratotomy
Laser-assisted Astigmatic keratotomy are performed by the VICTUS™ Femtosecond Laser Platform.

Detailed Description:

The purpose of this prospective phase IV study acts to address the predictability and effectiveness of astigmatic keratotomy in eyes after femtolaser-assisted cataract surgery. Within this prospective data collection the laser-assisted Arcuate Incisions are performed by the VICTUS™ Femtosecond Laser Platform.

This study will be conducted at Gemini eye clinic in Zlin, Czech Republic by Dr. Pavel Stodulka who will treat up to 50 eyes. Patients will be recruited according to the study inclusion/exclusion criteria.


Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Clear corneal media
  • Patients must be at least 40 years of age
  • Mono- or bilateral Cataract treatment
  • Keratometric astigmatism: ≥ 1.0 D and ≤ 3 D
  • Patients must have read, understood the Patient Information and signed the informed consent form
  • Patients are willing and able to return for follow-up examinations

Exclusion Criteria:

  • The maximum K- value may not exceed 60D, the minimal value may not be smaller than 37D
  • Pachymetry data for 7-8 mm zone are not available.
  • Corneal disease or pathology, such as corneal scaring or opacity, that precludes transmission of laser wavelength or that distorts laser light
  • Subjects with a poorly dilating pupil or other defect of the pupil that prevents the iris from adequate retraction peripherally
  • Lens/zonular instability such as, but not restricted to, Marfan's Syndrome, Pseudoexfoliation Syndrome, etc.
  • Manifest Glaucoma
  • Previous intraocular or corneal surgery of any kind, including any type of surgery for either refractive or therapeutic purposes in either eye
  • Known sensitivity to planned concomitant medications
  • Patients regularly taking medicines that could influence the result of the treatment respectively the vision
  • Patients with disorders of the ocular muscle, such as nystagmus or strabismus
  • Patients with keratoconus, keratectasia or other irregular cornea changes
  • Patients with connective tissue weakness
  • Patients who are blind on one eye
  • Subjects who are immune compromised or carrying diagnosis of connective tissue disease, clinically significant atopic disease, insulin dependent diabetes mellitus, autoimmune diseases, ocular herpes zoster or simplex, endocrine diseases, lupus, rheumatoid arthritis, collagenosis and other acute or chronic illnesses that will increase the risk to the subject or confound the outcomes of this study.
  • Abnormal examination results from slit lamp, fundus examination or IOL Master, age related changes are acceptable
  • Patients with eye diseases which decreases the visual acuity such as macular degeneration, macular edema, proliferative diabetic Retinopathy
  • Abnormal examination results from Topography, age related changes are acceptable
  • Patients who are pregnant or nursing
  • Patients with concentration disorders, epilepsy and other complicating diseases
  • Patients who are participating in another clinical study 30 days before
  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 identifier: NCT01885780

Czech Republic
Gemini Eye Clinic
Zlin, Czech Republic, 76001
Sponsors and Collaborators
Technolas Perfect Vision GmbH
Principal Investigator: Pavel Stodulka, Dr. med Gemini clinic, Zlin
Principal Investigator: Pavel Stodulka, Dr. med Gemini eye clinic
  More Information

Responsible Party: Technolas Perfect Vision GmbH Identifier: NCT01885780     History of Changes
Other Study ID Numbers: 1212
Study First Received: June 11, 2013
Last Updated: May 30, 2014

Keywords provided by Technolas Perfect Vision GmbH:
Astigmatism, arcuate incisions, astigmatic keratotomy

Additional relevant MeSH terms:
Refractive Errors
Eye Diseases processed this record on May 23, 2017