Trial record 11 of 25 for:    Open Studies | "Astigmatism"

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

This study is currently recruiting participants.
Verified October 2013 by Technolas Perfect Vision GmbH
Sponsor:
Information provided by (Responsible Party):
Technolas Perfect Vision GmbH
ClinicalTrials.gov Identifier:
NCT01885780
First received: June 11, 2013
Last updated: October 18, 2013
Last verified: October 2013
  Purpose

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
Astigmatism
Device: Laser-assisted Astigmatic keratotomy
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    • 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.


Estimated Enrollment: 50
Study Start Date: January 2013
Estimated Study Completion Date: May 2014
Estimated 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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01885780

Locations
Czech Republic
Gemini Eye Clinic Recruiting
Zlin, Czech Republic, 76001
Contact: Pavel Stodulka, Dr. med    +420734575158    barinkova@gemini.cz   
Contact: Eliška Bařinková    +420734575158    barinkova@gemini.cz   
Principal Investigator: Pavel Stodulka, Dr. med         
Sponsors and Collaborators
Technolas Perfect Vision GmbH
Investigators
Principal Investigator: Pavel Stodulka, Dr. med Gemini clinic, Zlin
Principal Investigator: Pavel Stodulka, Dr. med Gemini eye clinic
  More Information

No publications provided

Responsible Party: Technolas Perfect Vision GmbH
ClinicalTrials.gov Identifier: NCT01885780     History of Changes
Other Study ID Numbers: 1212
Study First Received: June 11, 2013
Last Updated: October 18, 2013
Health Authority: Czech Republic: Ethics Committee

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

Additional relevant MeSH terms:
Astigmatism
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on April 17, 2014