Femtosecond Laser-assisted Astigmatism Treatment

Femtosecond Laser-assisted Astigmatism Treatment (FLAAT)

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04321226

Acronym

FLAAT

Enrollment

130

Registered

2020-03-25

Start date

2017-07-10

Completion date

2022-04-01

Last updated

2021-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age Related Cataracts, Astigmatism

Keywords

Laser Cataract Surgery, Arcuate Keratotomy

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

Interventions

DEVICEFemtosecond Laser guided Arcuate Keratotomy

Astigmatism will be reduced in cataract surgery using a low energy Femtosecond Laser device

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Prospective interventional case series

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Austria

Contacts

Primary ContactLuca Schwarzenbacher, MD

luca.schwarzenbacher@meduniwien.ac.at0140400

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026