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

Phase IV Study_Prospective Evaluation of the Effectiveness of the Femtosecond Laser-assisted Refractive Astigmatic Keratotomy Following the Cataract Surgery.

This clinical phase IV study is an open, prospective phase IV study and acts to evaluate the effectiveness of the femtolaser-assisted astigmatic keratotomy.

Study Overview

• Status: Completed
• Conditions: Astigmatism
• Intervention / Treatment: Device: Laser-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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 4

Contacts and Locations

Study Locations

• Czech Republic
  • Zlin, Czech Republic, 76001
    • Gemini Eye Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Astigmatic keratotomy	Device: Laser-assisted Astigmatic keratotomy; Laser-assisted Astigmatic keratotomy are performed by the VICTUS™ Femtosecond Laser Platform.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Keratomic corneal astigmatism	The postoperative keratomic corneal astigmatism is in 60% of all eyes equal or better than 1.0D	The study endpoints will be calculated for the 3-Months follow-up examination.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	This end point is measured at the 3 Months Follow Up.

Collaborators and Investigators

• Sponsor: Technolas Perfect Vision GmbH
• Investigators: Principal Investigator: Pavel Stodulka, Dr. med, Gemini clinic, Zlin; Principal Investigator: Pavel Stodulka, Dr. med, Gemini Eye Clinic

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: June 11, 2013
• First Submitted That Met QC Criteria: June 20, 2013
• First Posted (Estimate): June 25, 2013

Study Record Updates

• Last Update Posted (Estimate): June 2, 2014
• Last Update Submitted That Met QC Criteria: May 30, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Astigmatism, arcuate incisions, astigmatic keratotomy
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: 1212 (Copenhagen University)