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

NCT02164994 | Unknown

• 1 other identifier: 1402
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Astigmatism

Keywords

Astigmatism, arcuate incisions, astigmatic keratotomy

Outcome Measures

Primary Outcomes (1)

• Postoperative keratometric cylinder

  Postoperative Astigmatism (keratometry) ≤ 1.0 D in 60% of eyes

  18 months after the VICTUS femtosecond laser-assisted arcuate incisions.

Secondary Outcomes (2)

• Postoperative Manifest Cylinder

  19 months after VICTUS femtosecond laser-assisted arcuate incisions treatment.

• Postoperative Objective Cylinder

  18 months after VICTUS femtosecond laser-assisted arcuate incisions treatment.

Eligibility Criteria

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

Study Population

Only the patients who were previously treated with VICTUS™ femtosecond laser-assisted arcuate incisions and successfully pass the eligibility criteria are eligible for this follow-up extension study.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Technolas Perfect Vision GmbH: lead

Study Sites (1)

Gemini Eye Clinic

Zlín, 76001, Czechia

RECRUITING

MeSH Terms

Conditions

Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Pavel Stodulka, Dr. med, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pavel Stodulka, Dr. med, PhD

CONTACT

+420734575158; barinkova@gemini.cz

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2014
• First Posted: June 17, 2014
• Study Start: April 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: November 1, 2015
• Last Updated: April 24, 2015

Record last verified: 2015-04

Locations

CZ (1)