Prospective Evaluation of the Long-term Effectiveness of the Femtosecond Laser-assisted Arcuate Incisions

NCT ID: NCT02164994

Last Updated: 2015-04-24

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2015-11-30

Brief Summary

This clinical study is an open, controlled, prospective, single center, single-surgeon, post-market-clinical-follow-up study to evaluate the long-term (18 months) effectiveness of the femtolaser-assisted astigmatic keratotomy.

Detailed Description

The purpose of this prospective post-market-clinical-follow-up study is to address the long-term effectiveness of arcuate incisions, in eyes after VICTUS femtosecond laser-assisted astigmatic keratotomy.

This study will be conducted at Gemini eye clinic in Zlin, Czech Republic by Dr. Pavel Stodulka who will examine up to 100 eyes who previously received VICTUS femtolaser-assisted arcuate incisions treatment.

Patients will be recruited according to the study inclusion/exclusion criteria.

Conditions

Astigmatism

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Clear corneal media
• Patients must be at least 40 years of age
• VICTUS™ femtosecond laser-assisted arcuate incisions surgery
• Preoperative Keratometric astigmatism: ≥ 1.0D and ≤ 3D
• 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

• Corneal disease or pathology, such as corneal scaring
• 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
• 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
• 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 IOLMaster; 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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Technolas Perfect Vision GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pavel Stodulka, Dr. med, PhD

Role: PRINCIPAL_INVESTIGATOR

Gemini clinic, Zlin Pavel Stodulka, Dr. med Study Principal Investigator Gemini eye clinic

Locations

Gemini Eye Clinic

Zlín, , Czechia

Site Status: RECRUITING

Countries

Czechia

Central Contacts

Pavel Stodulka, Dr. med, PhD

Role: CONTACT

barinkova@gemini.cz

+420734575158

Facility Contacts

Pavel Stodulka, Dr. med, PhD

Role: primary

barinkova@gemini.cz

+420734575158

Eliška Bařinková

Role: backup

barinkova@gemini.cz

+420734575158

Other Identifiers

1402

Identifier Type: -

Identifier Source: org_study_id