Status:
COMPLETED
Prospective Evaluation of the Effectiveness of the Femtosecond Laser-assisted Refractive Astigmatic Keratotomy.
Lead Sponsor:
Technolas Perfect Vision GmbH
Conditions:
Astigmatism
Eligibility:
All Genders
40+ years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT01885780
Start Date
January 1 2013
End Date
March 1 2014
Last Update
June 2 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Gemini Eye Clinic
Zlín, Czechia, 76001