Femtosecond Laser-assisted Astigmatism Treatment

Phase 4

• Conditions: Age Related Cataracts; Astigmatism

• Registration Number: NCT04321226
• Lead Sponsor: Medical University of Vienna

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-10
• Study First Submitted: 2020-03-23
• Study First Submitted QC: 2020-03-23
• Study First Posted: 2020-03-25
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-23
• Last Update Posted: 2021-02-24
• Primary Completion: 2022-03-05
• Study Completion: 2022-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 130

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Corneal Astigmatism one year after the intervention	1 year follow-up	H0: no change in postoperative refraction astigmatism H1: change in postoperative refraction astigmatism

Secondary Outcome Measures

Name	Time	Method
Precision and reproducibility of corneal cut depth	1 year follow-up	Corneal Incisions will be measured using an anterior segment SS-OCT

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria