AstigmatismNCT02164994
Prospective Evaluation of the Long-term Effectiveness of the Femtosecond Laser-assisted Arcuate Incisions
An observational study of Astigmatism, run by Technolas Perfect Vision GmbH at 1 site in Czechia.
Trial summary
This clinical study is an open, controlled, prospective, single center, single-surgeon, post-market-clinical-follow-up study to evaluate the long-term (18 months) effectiveness of the femtolaser-assisted astigmatic keratotomy. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Astigmatism
- How many people
- 100 participants
- Where
- 1 siteCzechia
- Study dates
- Apr 2014to Nov 2015
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Only the patients who were previously treated with VICTUS™ femtosecond laser-assisted arcuate incisions and successfully pass the eligibility criteria are eligible for this follow-up extension study.
Who may be able to join
- Clear corneal media
- Patients must be at least 40 years of age
- VICTUS™ femtosecond laser-assisted arcuate incisions surgery
- Preoperative Keratometric astigmatism: ≥ 1.0D and ≤ 3D
- Patients must have read, understood the Patient Information and signed the informed consent form
- Patients are willing and able to return for follow-up examinations
Who cannot join
- Corneal disease or pathology, such as corneal scaring
- Subjects with a poorly dilating pupil or other defect of the pupil that prevents the iris from adequate retraction peripherally
- Lens/zonular instability such as, but not restricted to, Marfan's Syndrome, Pseudoexfoliation Syndrome, etc.
- Manifest Glaucoma
- Known sensitivity to planned concomitant medications
- Patients regularly taking medicines that could influence the result of the treatment respectively the vision
Show all 16Show fewer
- Patients with disorders of the ocular muscle, such as nystagmus or strabismus
- Patients with keratoconus, keratectasia or other irregular cornea changes
- Patients with connective tissue weakness
- Subjects who are immune compromised or carrying diagnosis of connective tissue disease, clinically significant atopic disease, insulin dependent diabetes mellitus, autoimmune diseases, ocular herpes zoster or simplex, endocrine diseases, lupus, rheumatoid arthritis, collagenosis and other acute or chronic illnesses that will increase the risk to the subject or confound the outcomes of this study.
- Abnormal examination results from slit lamp, fundus examination or IOLMaster; age related changes are acceptable
- Patients with eye diseases which decreases the visual acuity such as macular degeneration, macular edema, proliferative diabetic retinopathy
- Abnormal examination results from topography, age related changes are acceptable
- Patients who are pregnant or nursing
- Patients with concentration disorders, epilepsy and other complicating diseases
- Patients who are participating in another clinical study 30 days before
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
Gemini Eye Clinic
Zlín, 76001
Pavel Stodulka, Dr. med, PhD, +420734575158, barinkova@gemini.cz
Eliška Bařinková, +420734575158, barinkova@gemini.cz
About this study
Official title: Prospective Evaluation of the Long-term (18 Months) Effectiveness of the Femtosecond Laser-assisted Arcuate Incisions Following Cataract Surgery
This clinical study is an open, controlled, prospective, single center, single-surgeon, post-market-clinical-follow-up study to evaluate the long-term (18 months) effectiveness of the femtolaser-assisted astigmatic keratotomy.
Read the detailed description
The purpose of this prospective post-market-clinical-follow-up study is to address the long-term effectiveness of arcuate incisions, in eyes after VICTUS femtosecond laser-assisted astigmatic keratotomy.
This study will be conducted at Gemini eye clinic in Zlin, Czech Republic by Dr. Pavel Stodulka who will examine up to 100 eyes who previously received VICTUS femtolaser-assisted arcuate incisions treatment.
Patients will be recruited according to the study inclusion/exclusion criteria.
- Conditions
- Astigmatism
- Keywords
- Astigmatism, arcuate incisions, astigmatic keratotomy
- Medical subject headings
- Astigmatism
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative keratometric cylinder
Postoperative Astigmatism (keratometry) ≤ 1.0 D in 60% of eyes
Measured: 18 months after the VICTUS femtosecond laser-assisted arcuate incisions.
Secondary outcomes (2)
Postoperative Manifest Cylinder
Postoperative Manifest Astigmatism (manifest refraction) ≤ 1.0 D in 60% of eyes
Measured: 19 months after VICTUS femtosecond laser-assisted arcuate incisions treatment.
Postoperative Objective Cylinder
Postoperative Objective Astigmatism (manifest refraction) ≤ 1.0 D in 60% of eyes
Measured: 18 months after VICTUS femtosecond laser-assisted arcuate incisions treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2014 (estimated)
- Study startApr 2014
- Primary completionSep 2015 (estimated)
- Study completionNov 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AstigmatismStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technolas Perfect Vision GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pavel Stodulka, Dr. med, PhD, Principal investigator, Gemini clinic, Zlin Pavel Stodulka, Dr. med Study Principal Investigator Gemini eye clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02164994
- Sponsor's protocol ID
- 1402
- Status last verified
- Apr 2015
- First submitted
- 13 Jun 2014
- Last updated
- 24 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of the Long-term (18 Months) Effectiveness of the Femtosecond Laser-assisted Arcuate Incisions Following Cataract Surgery
- ClinicalTrials.gov ID
- NCT02164994
- Acronym / sponsor ID
- 1402
- Conditions
- Astigmatism
- Keywords
- Astigmatism, arcuate incisions, astigmatic keratotomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Technolas Perfect Vision GmbHIndustry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Nov 2015 (estimated)
- First posted
- 17 Jun 2014 (estimated)
- 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.
This clinical study is an open, controlled, prospective, single center, single-surgeon, post-market-clinical-follow-up study to evaluate the long-term (18 months) effectiveness of the femtolaser-assisted astigmatic keratotomy.
Detailed description
The purpose of this prospective post-market-clinical-follow-up study is to address the long-term effectiveness of arcuate incisions, in eyes after VICTUS femtosecond laser-assisted astigmatic keratotomy.
This study will be conducted at Gemini eye clinic in Zlin, Czech Republic by Dr. Pavel Stodulka who will examine up to 100 eyes who previously received VICTUS femtolaser-assisted arcuate incisions treatment.
Patients will be recruited according to the study inclusion/exclusion criteria.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Only the patients who were previously treated with VICTUS™ femtosecond laser-assisted arcuate incisions and successfully pass the eligibility criteria are eligible for this follow-up extension study.
Key inclusion criteria (6 listed)
- Clear corneal media
- Patients must be at least 40 years of age
- VICTUS™ femtosecond laser-assisted arcuate incisions surgery
- Preoperative Keratometric astigmatism: ≥ 1.0D and ≤ 3D
- Patients must have read, understood the Patient Information and signed the informed consent form
Key exclusion criteria (16 listed)
- Corneal disease or pathology, such as corneal scaring
- Subjects with a poorly dilating pupil or other defect of the pupil that prevents the iris from adequate retraction peripherally
- Lens/zonular instability such as, but not restricted to, Marfan's Syndrome, Pseudoexfoliation Syndrome, etc.
- Manifest Glaucoma
- Known sensitivity to planned concomitant medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postoperative keratometric cylinder
Time frame: 18 months after the VICTUS femtosecond laser-assisted arcuate incisions.
Postoperative Astigmatism (keratometry) ≤ 1.0 D in 60% of eyes
2 secondary outcomes
Postoperative Manifest Cylinder
Time frame: 19 months after VICTUS femtosecond laser-assisted arcuate incisions treatment.
Postoperative Objective Cylinder
Time frame: 18 months after VICTUS femtosecond laser-assisted arcuate incisions treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2015.
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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.
Pavel Stodulka, Dr. med, PhD principal investigator
Gemini clinic, Zlin Pavel Stodulka, Dr. med Study Principal Investigator Gemini eye clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Astigmatism, run by Technolas Perfect Vision GmbH at 1 site in Czechia.
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 6 inclusion and 16 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 Apr 2015. 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 Czechia. 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.
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 Pavel Stodulka, Dr. med, PhD (+420734575158, barinkova@gemini.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative keratometric cylinder (time frame: 18 months after the VICTUS femtosecond laser-assisted arcuate incisions.). 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 Apr 2015.