Femtosecond Laser-assisted Astigmatism Treatment

Study Overview
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Brief Summary
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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

Official Title
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Femtosecond Laser-assisted Astigmatism Treatment (FLAAT)

Conditions
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Age Related Cataracts, Astigmatism

Intervention / Treatment
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* Device: Femtosecond Laser guided Arcuate Keratotomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective interventional case series
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Femtosecond Laser guided Arcuate Keratotomy<br>Arcuate keratotomy will be performed together with Laser cataract surgery | Device: Femtosecond Laser guided Arcuate Keratotomy<br>* Astigmatism will be reduced in cataract surgery using a low energy Femtosecond Laser device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Precision and reproducibility of corneal cut depth | Corneal Incisions will be measured using an anterior segment SS-OCT | 1 year follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laser Cataract Surgery, Arcuate Keratotomy