NCT01752218

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 19, 2012

Completed
13 days until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

May 22, 2014

Status Verified

May 1, 2014

Enrollment Period

1.2 years

First QC Date

December 14, 2012

Last Update Submit

May 21, 2014

Conditions

Astigmatism

Keywords

Femto-second Laserarcuate incisioncorneal astigmatismastigmatic keratotomyCataract

Outcome Measures

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.

    3 month postoperative

Secondary Outcomes (5)

  • topographic corneal cylinder

    3 month postoperative

  • abberrometric corneal astigmatism

    3 month postoperative

  • keratomic corneal astigmatism

    3 month postoperative

  • correction index based on keratometric corneal astigmatism

    3 month postoperative

  • correction index based on

    3 month postoperative

Study Arms (1)

Arcuate Incision

EXPERIMENTAL

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

Device: arcuate incision

Interventions

arcuate incisionDEVICE
Arcuate Incision

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clear corneal media
  • Patients must be at least 40 years of age
  • mono- or bilateral Cataract with uncorrected distance visual acuity (UCDVA)
  • or glare sensitivity
  • Vectorial averaged astigmatism of keratometric and topographic astigmatism:
  • 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

You may not qualify if:

  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Augen- & Laserklinik Castrop-Rauxel GmbH

Castrop-Rauxel, 44575, Germany

Location

Related Publications (1)

  • 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.

    PMID: 34464547DERIVED

Related Links

MeSH Terms

Conditions

AstigmatismCataract

Condition Hierarchy (Ancestors)

Refractive ErrorsEye DiseasesLens Diseases

Study Officials

  • Peter Hoffmann, Dr.

    Augen- & Laserklinik Castrop-Rauxel GmbH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2012

First Posted

December 19, 2012

Study Start

January 1, 2013

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

May 22, 2014

Record last verified: 2014-05

Locations

DE(1)