Femtosecond Laser-assisted Astigmatism Treatment
FLAAT
1 other identifier
interventional
130
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jul 2017
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 10, 2017
CompletedFirst Submitted
Initial submission to the registry
March 23, 2020
CompletedFirst Posted
Study publicly available on registry
March 25, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 5, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2022
CompletedFebruary 24, 2021
February 1, 2021
4.7 years
March 23, 2020
February 23, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Precision and reproducibility of corneal cut depth
1 year follow-up
Study Arms (1)
Femtosecond Laser guided Arcuate Keratotomy
EXPERIMENTALArcuate keratotomy will be performed together with Laser cataract surgery
Interventions
Astigmatism will be reduced in cataract surgery using a low energy Femtosecond Laser device
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of Vienna
Vienna, 1090, Austria
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
March 23, 2020
First Posted
March 25, 2020
Study Start
July 10, 2017
Primary Completion
March 5, 2022
Study Completion
April 1, 2022
Last Updated
February 24, 2021
Record last verified: 2021-02