Phase IV Study_Prospective Evaluation of the Effectiveness of the Femtosecond Laser-assisted Refractive Astigmatic Keratotomy Following the Cataract Surgery.
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Astigmatism
- Sponsor
- Technolas Perfect Vision GmbH
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Keratomic corneal astigmatism
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Keratomic corneal astigmatism
Time Frame: The study endpoints will be calculated for the 3-Months follow-up examination.
The postoperative keratomic corneal astigmatism is in 60% of all eyes equal or better than 1.0D
Secondary Outcomes
- Topographic corneal and subjective cylinder(This end point is measured at the 3 Months Follow Up.)