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NCT04321226: FLAAT
Femtosecond Laser-assisted Astigmatism Treatment
Phase 4 trial testing Femtosecond Laser guided Arcuate Keratotomy in Age Related Cataracts in 130 participants. Status unknown.
5 March 2022
Quick facts
| Lead sponsor | Medical University of Vienna |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 130 |
| Start date | 10 July 2017 |
| Primary completion | 5 March 2022 |
| Estimated completion | 1 April 2022 |
| Sites | 1 location across Austria |
Drugs / interventions tested
- Femtosecond Laser guided Arcuate Keratotomy
Conditions studied
- Age Related Cataracts — all drugs for Age Related Cataracts →
- Astigmatism — all drugs for Astigmatism →
Sponsor
Medical University of Vienna
Who can join
40 and older, any sex, with Age Related Cataracts or Astigmatism. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04321226
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04321226 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Medical University of Vienna
- Last refreshed: 24 February 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04321226.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing