Back to resultsFemtosecond Laser-assisted Astigmatism Treatment (FLAAT)
Primary Purpose
Age Related Cataracts, Astigmatism
Status
Unknown status
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
Femtosecond Laser guided Arcuate Keratotomy
Sponsored by
About this trial
This is an interventional treatment trial for Age Related Cataracts focused on measuring Laser Cataract Surgery, Arcuate Keratotomy
Eligibility Criteria
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
Sites / Locations
- Medical University of ViennaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Femtosecond Laser guided Arcuate Keratotomy
Arm Description
Arcuate keratotomy will be performed together with Laser cataract surgery
Outcomes
Primary Outcome Measures
Corneal Astigmatism one year after the intervention
H0: no change in postoperative refraction astigmatism H1: change in postoperative refraction astigmatism
Secondary Outcome Measures
Precision and reproducibility of corneal cut depth
Corneal Incisions will be measured using an anterior segment SS-OCT
Full Information
NCT ID
NCT04321226
First Posted
March 23, 2020
Last Updated
February 23, 2021
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT04321226
Brief Title
Femtosecond Laser-assisted Astigmatism Treatment
Acronym
FLAAT
Official Title
Femtosecond Laser-assisted Astigmatism Treatment (FLAAT)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 10, 2017 (Actual)
Primary Completion Date
March 5, 2022 (Anticipated)
Study Completion Date
April 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age Related Cataracts, Astigmatism
Keywords
Laser Cataract Surgery, Arcuate Keratotomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Prospective interventional case series
Masking
None (Open Label)
Allocation
N/A
Enrollment
130 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Femtosecond Laser guided Arcuate Keratotomy
Arm Type
Experimental
Arm Description
Arcuate keratotomy will be performed together with Laser cataract surgery
Intervention Type
Device
Intervention Name(s)
Femtosecond Laser guided Arcuate Keratotomy
Intervention Description
Astigmatism will be reduced in cataract surgery using a low energy Femtosecond Laser device
Primary Outcome Measure Information:
Title
Corneal Astigmatism one year after the intervention
Description
H0: no change in postoperative refraction astigmatism H1: change in postoperative refraction astigmatism
Time Frame
1 year follow-up
Secondary Outcome Measure Information:
Title
Precision and reproducibility of corneal cut depth
Description
Corneal Incisions will be measured using an anterior segment SS-OCT
Time Frame
1 year follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luca Schwarzenbacher, MD
Phone
0140400
Ext
79450
Email
luca.schwarzenbacher@meduniwien.ac.at
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rupert Menapace, MD
Phone
+43140400
Ext
66300
Email
rupert.menapace@meduniwien.ac.at
First Name & Middle Initial & Last Name & Degree
Christina Leydolt, MD
Phone
+43140400
Ext
79480
Email
christina.leydolt@meduniwien.ac.at
12. IPD Sharing Statement
Learn more about this trial
Femtosecond Laser-assisted Astigmatism Treatment
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