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

NCT01885780 | Completed Phase 4

• 1 other identifier: 1212
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Astigmatism

Keywords

Astigmatism, arcuate incisions, astigmatic keratotomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Topographic corneal and subjective cylinder

  This end point is measured at the 3 Months Follow Up.

Study Arms (1)

Astigmatic keratotomy

EXPERIMENTAL

Device: Laser-assisted Astigmatic keratotomy

Interventions

Laser-assisted Astigmatic keratotomy DEVICE

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

Astigmatic keratotomy

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Technolas Perfect Vision GmbH: lead

Study Sites (1)

Gemini Eye Clinic

Zlín, 76001, Czechia

Location

MeSH Terms

Conditions

Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Pavel Stodulka, Dr. med

  Gemini clinic, Zlin

  PRINCIPAL INVESTIGATOR

• Pavel Stodulka, Dr. med

  Gemini Eye Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2013
• First Posted: June 25, 2013
• Study Start: January 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: June 2, 2014

Record last verified: 2014-05

Locations

CZ (1)