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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Technolas Perfect Vision GmbH
ClinicalTrials.gov Identifier:
NCT01752218
First received: December 14, 2012
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Astigmatism
Device: arcuate incision

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single Centre Study to Address Precision and Refractive Predictability of Femtosecond Laser-assisted Astigmatic Keratotomy Following the Cataract Surgery

Resource links provided by NLM:


Further study details as provided by Technolas Perfect Vision GmbH:

Primary Outcome Measures:
  • subjective cylinder [ Time Frame: 3 month postoperative ] [ Designated as safety issue: No ]
    At the 3 month visit the subjective cylinder as measured with phoropter or trial frame is ≤ 0.75 D in 60% of the eyes.


Secondary Outcome Measures:
  • topographic corneal cylinder [ Time Frame: 3 month postoperative ] [ Designated as safety issue: No ]
    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

  • abberrometric corneal astigmatism [ Time Frame: 3 month postoperative ] [ Designated as safety issue: No ]
    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.

  • keratomic corneal astigmatism [ Time Frame: 3 month postoperative ] [ Designated as safety issue: No ]
    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

  • correction index based on keratometric corneal astigmatism [ Time Frame: 3 month postoperative ] [ Designated as safety issue: No ]
    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.

  • correction index based on [ Time Frame: 3 month postoperative ] [ Designated as safety issue: No ]
    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.


Enrollment: 43
Study Start Date: January 2013
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arcuate Incision
Study arm will consist of patients who show cataract and corneal astigmatism.
Device: arcuate incision

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01752218

Locations
Germany
Augen- & Laserklinik Castrop-Rauxel GmbH
Castrop-Rauxel, Germany, 44575
Sponsors and Collaborators
Technolas Perfect Vision GmbH
Investigators
Principal Investigator: Peter Hoffmann, Dr. Augen- & Laserklinik Castrop-Rauxel GmbH
  More Information

Additional Information:
No publications provided

Responsible Party: Technolas Perfect Vision GmbH
ClinicalTrials.gov Identifier: NCT01752218     History of Changes
Other Study ID Numbers: 1209
Study First Received: December 14, 2012
Last Updated: May 21, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by Technolas Perfect Vision GmbH:
Femto-second Laser
arcuate incision
corneal astigmatism
astigmatic keratotomy
Cataract

Additional relevant MeSH terms:
Astigmatism
Cataract
Eye Diseases
Lens Diseases
Refractive Errors

ClinicalTrials.gov processed this record on November 20, 2014