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Femtosecond Laser-assisted Astigmatism Treatment

NCT04321226 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2021-02-24

No results posted yet for this study

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

Conditions

  • Age Related Cataracts
  • Astigmatism

Interventions

DEVICE

Femtosecond Laser guided Arcuate Keratotomy

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

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-10
Primary Completion
2022-03-05
Completion
2022-04-01

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04321226 on ClinicalTrials.gov