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

Astigmatism Clinical Trial

Official title:

Prospective Evaluation of the Long-term (18 Months) Effectiveness of the Femtosecond Laser-assisted Arcuate Incisions Following Cataract Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02164994
• Other study ID #: 1402
• Status: Recruiting
• Phase: N/A
• First received: June 13, 2014
• Last updated: April 23, 2015
• Start date: April 2014
• Est. completion date: November 2015

Study information

• Verified date: April 2015
• Source: Technolas Perfect Vision GmbH
• Contact: Pavel Stodulka, Dr. med, PhD
• Phone: +420734575158
• Email: barinkova[@]gemini.cz
• Is FDA regulated: No
• Health authority: Czech Republic: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Astigmatism

Locations

Country	Name	City	State
Czech Republic	Gemini Eye Clinic	Zlin

Sponsors (1)

Lead Sponsor	Collaborator
Technolas Perfect Vision GmbH

Country where clinical trial is conducted

Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative keratometric cylinder	Postoperative Astigmatism (keratometry) = 1.0 D in 60% of eyes	18 months after the VICTUS femtosecond laser-assisted arcuate incisions.	No
Secondary	Postoperative Manifest Cylinder	Postoperative Manifest Astigmatism (manifest refraction) = 1.0 D in 60% of eyes	19 months after VICTUS femtosecond laser-assisted arcuate incisions treatment.	No
Secondary	Postoperative Objective Cylinder	Postoperative Objective Astigmatism (manifest refraction) = 1.0 D in 60% of eyes	18 months after VICTUS femtosecond laser-assisted arcuate incisions treatment.	No