CClinicalTrials.gg
Sign In
Status unknownNCT02164994Updated Apr 24, 2015

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

An observational study in Astigmatism, sponsored by Technolas Perfect Vision GmbH. Status unknown at 1 site in Czech Republic. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-04-24.

Sponsored by Technolas Perfect Vision GmbH · Observational

The sponsor has not verified this record recently (last verified Apr 2015), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
40 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Astigmatism

Browse trials for

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 planned enrollment of 100 is close to the median of 93 across 84 observational 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
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.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Postoperative keratometric cylinder

    Postoperative Astigmatism (keratometry) ≤ 1.0 D in 60% of eyes

    Time frame: 18 months after the VICTUS femtosecond laser-assisted arcuate incisions.

Secondary outcomes

  1. Postoperative Manifest Cylinder

    Postoperative Manifest Astigmatism (manifest refraction) ≤ 1.0 D in 60% of eyes

    Time frame: 19 months after VICTUS femtosecond laser-assisted arcuate incisions treatment.

  2. Postoperative Objective Cylinder

    Postoperative Objective Astigmatism (manifest refraction) ≤ 1.0 D in 60% of eyes

    Time frame: 18 months after VICTUS femtosecond laser-assisted arcuate incisions treatment.

07

Study locations

1 of 1 sites recruiting
  • Gemini Eye Clinic
    Zlin, 76001, Czech Republic
    • Pavel Stodulka, Dr. med, PhD · Contact · barinkova@gemini.cz · +420734575158
    • Eliška Bařinková · Contact · barinkova@gemini.cz · +420734575158
    • Pavel Stodulka, Dr. med, PhD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 24, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02164994
Lead sponsor
Technolas Perfect Vision GmbH
Responsible party
Sponsor
First posted
Jun 17, 2014
Start date
Apr 2014
Primary completion
Sep 2015 (estimated)
Completion
Nov 2015 (estimated)
Last update
Apr 24, 2015

Study contacts

Pavel Stodulka, Dr. med, PhD
Contact
barinkova@gemini.cz
+420734575158
Pavel Stodulka, Dr. med, PhD
principal investigator · Gemini clinic, Zlin Pavel Stodulka, Dr. med Study Principal Investigator Gemini eye clinic

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Astigmatism→

Other studies from this sponsor

Technolas Perfect Vision GmbH

Start the discussion