Femtosecond Laser-assisted Astigmatism Treatment

NCT ID: NCT04321226

Last Updated: 2021-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-10

Study Completion Date

2022-04-01

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

Detailed Description

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Conditions

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Age Related Cataracts Astigmatism

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective interventional case series
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Femtosecond Laser guided Arcuate Keratotomy

Arcuate keratotomy will be performed together with Laser cataract surgery

Group Type EXPERIMENTAL

Femtosecond Laser guided Arcuate Keratotomy

Intervention Type DEVICE

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

Interventions

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Femtosecond Laser guided Arcuate Keratotomy

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

Intervention Type DEVICE

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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Rupert Menapace

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Medical University of Vienna

Vienna, , Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Luca Schwarzenbacher, MD

Role: CONTACT

0140400 ext. 79450

Facility Contacts

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Rupert Menapace, MD

Role: primary

+43140400 ext. 66300

Christina Leydolt, MD

Role: backup

+43140400 ext. 79480

Other Identifiers

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1422/2017

Identifier Type: -

Identifier Source: org_study_id

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