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Prospective Evaluation of the Long-term Effectiveness of the Femtosecond Laser-assisted Arcuate Incisions

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ClinicalTrials.gov Identifier: NCT02164994
Recruitment Status : Unknown
Verified April 2015 by Technolas Perfect Vision GmbH.
Recruitment status was:  Recruiting
First Posted : June 17, 2014
Last Update Posted : April 24, 2015
Sponsor:
Information provided by (Responsible Party):
Technolas Perfect Vision GmbH

Brief Summary:
This clinical study is an open, controlled, prospective, single center, single-surgeon, post-market-clinical-follow-up study to evaluate the long-term (18 months) effectiveness of the femtolaser-assisted astigmatic keratotomy.

Condition or disease
Astigmatism

Detailed Description:

The purpose of this prospective post-market-clinical-follow-up study is to address the long-term effectiveness of arcuate incisions, in eyes after VICTUS femtosecond laser-assisted astigmatic keratotomy.

This study will be conducted at Gemini eye clinic in Zlin, Czech Republic by Dr. Pavel Stodulka who will examine up to 100 eyes who previously received VICTUS femtolaser-assisted arcuate incisions treatment.

Patients will be recruited according to the study inclusion/exclusion criteria.


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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Evaluation of the Long-term (18 Months) Effectiveness of the Femtosecond Laser-assisted Arcuate Incisions Following Cataract Surgery
Study Start Date : April 2014
Estimated Primary Completion Date : September 2015
Estimated Study Completion Date : November 2015



Primary Outcome Measures :
  1. Postoperative keratometric cylinder [ Time Frame: 18 months after the VICTUS femtosecond laser-assisted arcuate incisions. ]
    Postoperative Astigmatism (keratometry) ≤ 1.0 D in 60% of eyes


Secondary Outcome Measures :
  1. Postoperative Manifest Cylinder [ Time Frame: 19 months after VICTUS femtosecond laser-assisted arcuate incisions treatment. ]
    Postoperative Manifest Astigmatism (manifest refraction) ≤ 1.0 D in 60% of eyes

  2. Postoperative Objective Cylinder [ Time Frame: 18 months after VICTUS femtosecond laser-assisted arcuate incisions treatment. ]
    Postoperative Objective Astigmatism (manifest refraction) ≤ 1.0 D in 60% of eyes



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Only the patients who were previously treated with VICTUS™ femtosecond laser-assisted arcuate incisions and successfully pass the eligibility criteria are eligible for this follow-up extension study.
Criteria

Inclusion Criteria:

  • Clear corneal media
  • Patients must be at least 40 years of age
  • VICTUS™ femtosecond laser-assisted arcuate incisions surgery
  • Preoperative Keratometric astigmatism: ≥ 1.0D and ≤ 3D
  • 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:

  • Corneal disease or pathology, such as corneal scaring
  • 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
  • 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
  • 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 IOLMaster; 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02164994


Contacts
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Contact: Pavel Stodulka, Dr. med, PhD +420734575158 barinkova@gemini.cz

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

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Responsible Party: Technolas Perfect Vision GmbH
ClinicalTrials.gov Identifier: NCT02164994     History of Changes
Other Study ID Numbers: 1402
First Posted: June 17, 2014    Key Record Dates
Last Update Posted: April 24, 2015
Last Verified: April 2015

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

Additional relevant MeSH terms:
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Surgical Wound
Astigmatism
Wounds and Injuries
Refractive Errors
Eye Diseases