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

Technolas Perfect Vision

Status and phase

Completed

Phase 4

Conditions

Astigmatism

Treatments

Device: Laser-assisted Astigmatic keratotomy

Study type

Interventional

Funder types

Industry

Identifiers

NCT01885780

1212

Details and patient eligibility

About

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

Full 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.

Enrollment

45 patients

Sex

All

Ages

40+ years old

Volunteers

Accepts 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