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CompletedNCT01752218Updated May 22, 2014

A Study to Address Precision and Refractive Predictability of Femtosecond Laser-assisted Astigmatic Keratotomy Following the Cataract Surgery

An interventional study of arcuate incision in Astigmatism, sponsored by Technolas Perfect Vision GmbH. Completed at 1 site in Germany. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2014-05-22.

Sponsored by Technolas Perfect Vision GmbH · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
43
Allocation
Not applicable
Ages
40 Years and older
Sex
All
01

Study summary

The purpose of this open, prospective study is to address the effectiveness and precision of the VICTUS™ Femtosecond Laser Platform-assisted astigmatic keratotomy after femtolaser-assisted cataract surgery.

Read the detailed description

Corneal astigmatism after cataract surgery represents a considerable obstacle in the visual rehabilitation of patients. Up-to-date astigmatic keratotomy represents a standardized and effective procedure that allows decreasing of naturally occurring and surgically induced astigmatism. The shape and architecture of the Arcuate Incisions are pre-calculated based on a particular chosen nomogram. The different parameters of the Arcuate Incisions as radius, opening and position angle and cutting depth can be achieved precisely by the laser technology.

The laser-assisted Cataract surgery and the Arcuate Incisions are performed by means of a femtosecond laser (VICTUS™ FEMTOSECOND LASER PLATFORM®, Technolas Perfect Vision GmbH, Munich, Germany) which is in the presented study under investigation and is already CE-approved.

For this open, prospective data collection several selection criteria have been defined in order to obtain a data set of minimal 43 eyes and maximal 50 eyes. Depending on whether they will be treated unilateral or bilateral the number of subjects enrolled within this study sums up to 22-50 patients. The data is gathered in the Castrop-Rauxel Augenklinik and only from one experienced surgeon.

02

Conditions studied

  • Astigmatism

Keywords

  • Femto-second Laser
  • arcuate incision
  • corneal astigmatism
  • astigmatic keratotomy
  • Cataract
03

In context

Cataract

1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.

This study's enrollment of 43 is below the median of 80 across 1,155 interventional studies indexed under Cataract.

Browse Cataract 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
No

Inclusion criteria

  • Clear corneal media
  • Patients must be at least 40 years of age

  • mono- or bilateral Cataract with uncorrected distance visual acuity (UCDVA)

    • 0.63 or glare sensitivity

  • Vectorial averaged astigmatism of keratometric and topographic astigmatism:

    • 1.0 D and ≤ 2.0 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 does not include examination results at an radius of 4.25 mm
  • 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
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
43 participants (actual)

Study arms

  • Experimental
    Arcuate Incision

    Study arm will consist of patients who show cataract and corneal astigmatism.

    Device: arcuate incision

Interventions

  • Devicearcuate incision
06

What researchers measure

Primary outcomes

  1. subjective cylinder

    At the 3 month visit the subjective cylinder as measured with phoropter or trial frame is ≤ 0.75 D in 60% of the eyes.

    Time frame: 3 month postoperative

Secondary outcomes

  1. topographic corneal cylinder

    At the 3 month visit the value of postoperative corneal astigmatism of the central 3 mm zone, measured with topography, is ≤ 1.0 D in 60% of the eyes

    Time frame: 3 month postoperative

  2. abberrometric corneal astigmatism

    At the 3 month visit the value of postoperative corneal astigmatism of the central 3 mm zone, measured with aberrometry, is ≤ 1.0 D in 60% of the eyes.

    Time frame: 3 month postoperative

  3. keratomic corneal astigmatism

    At the 3 month visit the value of postoperative corneal astigmatism of the central 3 mm zone, measured with keratometry, is ≤ 1.0 D in 60% of the eyes

    Time frame: 3 month postoperative

  4. correction index based on keratometric corneal astigmatism

    At 3 month visit the value of the correction index based on preoperative and postoperative keratometric corneal astigmatism is 0.9+- 0,35 in 70% of the eyes.

    Time frame: 3 month postoperative

  5. correction index based on

    At 3 month visit the value of the correction index based on preoperative keratometric corneal astigmatism and postoperative subjective astigmatism is 0.9+- 0,35 in 70% of the eyes.

    Time frame: 3 month postoperative

07

Study locations

1 site
  • Augen- & Laserklinik Castrop-Rauxel GmbH
    Castrop-Rauxel, 44575, Germany
08

References and documents

Publications

  • Wendelstein JA, Hoffmann PC, Schwarzenbacher L, Fischinger IR, Hirnschall N, Menapace R, Langenbucher A, Findl O, Bolz M. Lasting Effects: Seven Year Results of the Castrop Nomogram for Femtosecond Laser-Assisted Paired Corneal Arcuate Incisions. Curr Eye Res. 2022 Feb;47(2):225-232. doi: 10.1080/02713683.2021.1975761. Epub 2021 Sep 7. PubMed 34464547 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01752218
Lead sponsor
Technolas Perfect Vision GmbH
Responsible party
Sponsor
First posted
Dec 19, 2012
Start date
Jan 2013
Primary completion
Apr 2014
Completion
Apr 2014
Last update
May 22, 2014

Study contacts

Peter Hoffmann, Dr.
principal investigator · Augen- & Laserklinik Castrop-Rauxel GmbH

Oversight

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

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