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CompletedNCT01885780Updated Jun 2, 2014

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

A Phase 4 interventional study of Laser-assisted Astigmatic keratotomy in Astigmatism, sponsored by Technolas Perfect Vision GmbH. Completed at 1 site in Czech Republic. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-06-02.

Sponsored by Technolas Perfect Vision GmbH · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
45
Allocation
Not applicable
Ages
40 Years and older
Sex
All
01

Study summary

This clinical phase IV study is an open, prospective phase IV study and acts to evaluate the effectiveness of the femtolaser-assisted astigmatic keratotomy.

Read the 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.

02

Conditions studied

  • Astigmatism

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Keywords

  • Astigmatism, arcuate incisions, astigmatic keratotomy
03

In context

Astigmatism

413 studies on the registry are indexed under Astigmatism; 55 are open to participants now.

This study's enrollment of 45 is below the median of 55 across 321 interventional studies indexed under Astigmatism.

Browse Astigmatism studies →

Lead sponsor

Technolas Perfect Vision GmbH is the lead sponsor of 18 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
45 participants (actual)

Study arms

  • Experimental
    Astigmatic keratotomy

    Device: Laser-assisted Astigmatic keratotomy

Interventions

  • DeviceLaser-assisted Astigmatic keratotomy

    Laser-assisted Astigmatic keratotomy are performed by the VICTUS™ Femtosecond Laser Platform.

06

What researchers measure

Primary outcomes

  1. Keratomic corneal astigmatism

    The postoperative keratomic corneal astigmatism is in 60% of all eyes equal or better than 1.0D

    Time frame: The study endpoints will be calculated for the 3-Months follow-up examination.

Secondary outcomes

  1. Topographic corneal and subjective cylinder

    * 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.

    Time frame: This end point is measured at the 3 Months Follow Up.

07

Study locations

1 site
  • Gemini Eye Clinic
    Zlin, 76001, Czech Republic
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 2, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01885780
Lead sponsor
Technolas Perfect Vision GmbH
Responsible party
Sponsor
First posted
Jun 25, 2013
Start date
Jan 2013
Primary completion
Mar 2014
Completion
Mar 2014
Last update
Jun 2, 2014

Study contacts

Pavel Stodulka, Dr. med
principal investigator · Gemini clinic, Zlin
Pavel Stodulka, Dr. med
principal investigator · Gemini Eye Clinic

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.

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