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

Astigmatism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01885780
• Other study ID #: 1212
• Status: Completed
• Phase: Phase 4
• First received: June 11, 2013
• Last updated: May 30, 2014
• Start date: January 2013
• Est. completion date: March 2014

Study information

• Verified date: May 2014
• Source: Technolas Perfect Vision GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Astigmatism

Intervention

Device:
• Laser-assisted Astigmatic keratotomy
Laser-assisted Astigmatic keratotomy are performed by the VICTUS™ Femtosecond Laser Platform.

Locations

Country	Name	City	State
Czech Republic	Gemini Eye Clinic	Zlin

Sponsors (1)

Lead Sponsor	Collaborator
Technolas Perfect Vision GmbH

Country where clinical trial is conducted

Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	No