Age Related CataractsPhase 4FLAATNCT04321226
Femtosecond Laser-assisted Astigmatism Treatment
A Phase 4 study testing Femtosecond Laser guided Arcuate Keratotomy in people with Age Related Cataracts and Astigmatism, run by Medical University of Vienna at 1 site in Austria.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Age Related Cataracts, Astigmatism
- What is being tested?
- Femtosecond Laser guided Arcuate Keratotomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteAustria
- Study dates
- 10 Jul 2017to 1 Apr 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Corneal abnormality
- Preceding ocular surgery or trauma
- Uncontrolled glaucoma
- Proliferative diabetic retinopathy
- Iris neovascularization
- History of uveitis/iritis
Show all 10Show fewer
- Microphthalmus
- Recurrent intraocular inflammation of unknown etiology
- Blind fellow eye
- Uncontrolled systemic or ocular disease
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, 1090
Rupert Menapace, MD, +43140400 ext. 66300, rupert.menapace@meduniwien.ac.at
Christina Leydolt, MD, +43140400 ext. 79480, christina.leydolt@meduniwien.ac.at
About this study
Official title: Femtosecond Laser-assisted Astigmatism Treatment (FLAAT)
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
- Being tested
- Femtosecond Laser guided Arcuate Keratotomy
- Keywords
- Laser Cataract Surgery, Arcuate Keratotomy
- Medical subject headings
- Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femtosecond Laser guided Arcuate KeratotomyDevice
Astigmatism will be reduced in cataract surgery using a low energy Femtosecond Laser device
| Study group | Role | What they receive |
|---|---|---|
| Femtosecond Laser guided Arcuate Keratotomy | Experimental | Arcuate keratotomy will be performed together with Laser cataract surgery Receives: Device: Femtosecond Laser guided Arcuate Keratotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal Astigmatism one year after the intervention
H0: no change in postoperative refraction astigmatism H1: change in postoperative refraction astigmatism
Measured: 1 year follow-up
Secondary outcomes (1)
Precision and reproducibility of corneal cut depth
Corneal Incisions will be measured using an anterior segment SS-OCT
Measured: 1 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2020
- Study start10 Jul 2017
- Primary completion5 Mar 2022 (estimated)
- Study completion1 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age Related CataractsStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective interventional case series
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rupert Menapace, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04321226
- Sponsor's protocol ID
- 1422/2017
- Acronym
- FLAAT
- Status last verified
- Feb 2021
- First submitted
- 23 Mar 2020
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Femtosecond Laser-assisted Astigmatism Treatment (FLAAT)
- ClinicalTrials.gov ID
- NCT04321226
- Acronym / sponsor ID
- FLAAT / 1422/2017
- Conditions
- Age Related Cataracts, Astigmatism
- Keywords
- Laser Cataract Surgery, Arcuate Keratotomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 10 Jul 2017 (actual)
- Primary completion
- 5 Mar 2022 (estimated)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 25 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective interventional case series
| Arm | Type | Receives |
|---|---|---|
| Femtosecond Laser guided Arcuate Keratotomy | Experimental | Device: Femtosecond Laser guided Arcuate KeratotomyArcuate keratotomy will be performed together with Laser cataract surgery |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (10 listed)
- Corneal abnormality
- Preceding ocular surgery or trauma
- Uncontrolled glaucoma
- Proliferative diabetic retinopathy
- Iris neovascularization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Femtosecond Laser guided Arcuate KeratotomyAstigmatism will be reduced in cataract surgery using a low energy Femtosecond Laser device | Device | Femtosecond Laser guided Arcuate Keratotomy |
Primary outcome
Corneal Astigmatism one year after the intervention
Time frame: 1 year follow-up
H0: no change in postoperative refraction astigmatism H1: change in postoperative refraction astigmatism
1 secondary outcome
Precision and reproducibility of corneal cut depth
Time frame: 1 year follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Femtosecond Laser guided Arcuate Keratotomy in people with Age Related Cataracts and Astigmatism, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luca Schwarzenbacher, MD (0140400 ext. 79450, luca.schwarzenbacher@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corneal Astigmatism one year after the intervention (time frame: 1 year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2021.