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

Primary Purpose

Astigmatism

Status
Completed
Phase
Phase 4
Locations
Czech Republic
Study Type
Interventional
Intervention
Laser-assisted Astigmatic keratotomy
Sponsored by
Technolas Perfect Vision GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Astigmatism focused on measuring Astigmatism, arcuate incisions, astigmatic keratotomy

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:

  • 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

Sites / Locations

  • Gemini Eye Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Astigmatic keratotomy

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
June 11, 2013
Last Updated
May 30, 2014
Sponsor
Technolas Perfect Vision GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT01885780
Brief Title
Prospective Evaluation of the Effectiveness of the Femtosecond Laser-assisted Refractive Astigmatic Keratotomy.
Official Title
Phase IV Study_Prospective Evaluation of the Effectiveness of the Femtosecond Laser-assisted Refractive Astigmatic Keratotomy Following the Cataract Surgery.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technolas Perfect Vision GmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Astigmatism
Keywords
Astigmatism, arcuate incisions, astigmatic keratotomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Astigmatic keratotomy
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Laser-assisted Astigmatic keratotomy
Intervention Description
Laser-assisted Astigmatic keratotomy are performed by the VICTUS™ Femtosecond Laser Platform.
Primary Outcome Measure Information:
Title
Keratomic corneal astigmatism
Description
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 Outcome Measure Information:
Title
Topographic corneal and subjective cylinder
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pavel Stodulka, Dr. med
Organizational Affiliation
Gemini clinic, Zlin
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pavel Stodulka, Dr. med
Organizational Affiliation
Gemini Eye Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gemini Eye Clinic
City
Zlin
ZIP/Postal Code
76001
Country
Czech Republic

12. IPD Sharing Statement

Learn more about this trial

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

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