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NCT04321226 Clinical Trial

Femtosecond Laser-assisted Astigmatism Treatment

Astigmatism Clinical Trial

— FLAAT  

Official title:
Femtosecond Laser-assisted Astigmatism Treatment (FLAAT)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04321226
Other study ID # 1422/2017
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date July 10, 2017
Est. completion date April 1, 2022

Study information
Verified date February 2021
Source Medical University of Vienna
Contact Luca Schwarzenbacher, MD
Phone 0140400
Email luca.schwarzenbacher@meduniwien.ac.at
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The investigational device is an approved femtosecond laser (FSL) device with an integrated imaging system to perform certain steps of the cataract procedure including arcuate incisions (AI) correcting astigmatism, also referred to as arcuate keratotomy (AK). The FSL will perform anterior capsulotomy and lens fragmentation in individuals suffering from age-related cataract with need of cataract surgery and additionally perform arcuate keratotomy in individuals with more than 1.0 Diopter (dpt) of astigmatism. Cataract surgery will be performed in subjects who have signed an informed consent form. Postoperative examinations will be implemented in accordance with the approved Investigational Plan on subjects and includes: postoperative refraction, visual acuity, slitlamp examination, and corneal topography

Recruitment information / eligibility
Status Recruiting
Enrollment 130
Est. completion date April 1, 2022
Est. primary completion date March 5, 2022
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility Inclusion Criteria: - Age-related cataract necessitating lens extraction and posterior IOL implantation - Regular corneal astigmatism between 1.0 and 2.5 DPT - Age 40 and older (females of childbearing age will be interviewed if pregnancy is possible) Exclusion Criteria: - Corneal abnormality - Preceding ocular surgery or trauma - Uncontrolled glaucoma - Proliferative diabetic retinopathy - Iris neovascularization - History of uveitis/iritis - Microphthalmus - Recurrent intraocular inflammation of unknown etiology - Blind fellow eye - Uncontrolled systemic or ocular disease

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Femtosecond Laser guided Arcuate Keratotomy
Astigmatism will be reduced in cataract surgery using a low energy Femtosecond Laser device

Locations
Country Name City State
Austria Medical University of Vienna Vienna

Sponsors (1)
Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary Corneal Astigmatism one year after the intervention H0: no change in postoperative refraction astigmatism H1: change in postoperative refraction astigmatism 1 year follow-up
Secondary Precision and reproducibility of corneal cut depth Corneal Incisions will be measured using an anterior segment SS-OCT 1 year follow-up
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