Femtosecond Laser-assisted Astigmatism Treatment

Medical University of Vienna130 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

130

Conditions

Age Related Cataracts Astigmatism

Interventions

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Corneal Astigmatism one year after the intervention

H0: no change in postoperative refraction astigmatism H1: change in postoperative refraction astigmatism