AstigmatismPhase 4NCT01885780
Prospective Evaluation of the Effectiveness of the Femtosecond Laser-assisted Refractive Astigmatic Keratotomy.
A Phase 4 study testing Laser-assisted Astigmatic keratotomy in people with Astigmatism, run by Technolas Perfect Vision GmbH at 1 site in Czechia.
Trial summary
This clinical phase IV study is an open, prospective phase IV study and acts to evaluate the 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
- What is being tested?
- Laser-assisted Astigmatic keratotomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteCzechia
- Study dates
- Jan 2013to Mar 2014
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clear corneal media
- Patients must be at least 40 years of age
- Mono- or bilateral Cataract treatment
- Keratometric astigmatism: ≥ 1.0 D and ≤ 3 D
- 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
- The maximum K- value may not exceed 60D, the minimal value may not be smaller than 37D
- Pachymetry data for 7-8 mm zone are not available.
- Corneal disease or pathology, such as corneal scaring or opacity, that precludes transmission of laser wavelength or that distorts laser light
- 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
Show all 20Show fewer
- Previous intraocular or corneal surgery of any kind, including any type of surgery for either refractive or therapeutic purposes in either eye
- Known sensitivity to planned concomitant medications
- Patients regularly taking medicines that could influence the result of the treatment respectively the vision
- 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
- Patients who are blind on one eye
- 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 IOL Master, 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.
About this study
Official title: Phase IV Study_Prospective Evaluation of the Effectiveness of the Femtosecond Laser-assisted Refractive Astigmatic Keratotomy Following the Cataract Surgery.
This clinical phase IV study is an open, prospective phase IV study and acts to evaluate the effectiveness of the femtolaser-assisted astigmatic keratotomy.
Read the detailed description
The purpose of this prospective phase IV study acts to address the predictability and effectiveness of astigmatic keratotomy in eyes after femtolaser-assisted cataract surgery. Within this prospective data collection the laser-assisted Arcuate Incisions are performed by the VICTUS™ Femtosecond Laser Platform.
This study will be conducted at Gemini eye clinic in Zlin, Czech Republic by Dr. Pavel Stodulka who will treat up to 50 eyes. Patients will be recruited according to the study inclusion/exclusion criteria.
- Conditions
- Astigmatism
- Being tested
- Laser-assisted Astigmatic keratotomy
- Keywords
- Astigmatism, arcuate incisions, astigmatic keratotomy
- Medical subject headings
- Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser-assisted Astigmatic keratotomyDevice
Laser-assisted Astigmatic keratotomy are performed by the VICTUS™ Femtosecond Laser Platform.
| Study group | Role | What they receive |
|---|---|---|
| Astigmatic keratotomy | Experimental | Not described Receives: Device: Laser-assisted Astigmatic keratotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Keratomic corneal astigmatism
The postoperative keratomic corneal astigmatism is in 60% of all eyes equal or better than 1.0D
Measured: The study endpoints will be calculated for the 3-Months follow-up examination.
Secondary outcomes (1)
Topographic corneal and subjective cylinder
- The postoperative astigmatism in topography is in 60% of all eyes equal or better than 1.0D
- The postoperative subjective astigmatism in manifest refraction is in 60% of all eyes equal or better than 1D.
Measured: This end point is measured at the 3 Months 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 Jun 2013 (estimated)
- Study startJan 2013
- Primary completionMar 2014
- Study completionMar 2014
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technolas Perfect Vision GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pavel Stodulka, Dr. med, Principal investigator, Gemini clinic, ZlinPavel Stodulka, Dr. med, Principal investigator, Gemini Eye Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01885780
- Sponsor's protocol ID
- 1212
- Status last verified
- May 2014
- First submitted
- 11 Jun 2013
- Last updated
- 2 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Study_Prospective Evaluation of the Effectiveness of the Femtosecond Laser-assisted Refractive Astigmatic Keratotomy Following the Cataract Surgery.
- ClinicalTrials.gov ID
- NCT01885780
- Acronym / sponsor ID
- 1212
- Conditions
- Astigmatism
- Keywords
- Astigmatism, arcuate incisions, astigmatic keratotomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Technolas Perfect Vision GmbHIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 25 Jun 2013 (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 phase IV study is an open, prospective phase IV study and acts to evaluate the effectiveness of the femtolaser-assisted astigmatic keratotomy.
Detailed description
The purpose of this prospective phase IV study acts to address the predictability and effectiveness of astigmatic keratotomy in eyes after femtolaser-assisted cataract surgery. Within this prospective data collection the laser-assisted Arcuate Incisions are performed by the VICTUS™ Femtosecond Laser Platform.
This study will be conducted at Gemini eye clinic in Zlin, Czech Republic by Dr. Pavel Stodulka who will treat up to 50 eyes. Patients will be recruited according to the study inclusion/exclusion criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Astigmatic keratotomy | Experimental | Device: Laser-assisted Astigmatic keratotomy |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Clear corneal media
- Patients must be at least 40 years of age
- Mono- or bilateral Cataract treatment
- Keratometric astigmatism: ≥ 1.0 D and ≤ 3 D
- Patients must have read, understood the Patient Information and signed the informed consent form
Key exclusion criteria (20 listed)
- The maximum K- value may not exceed 60D, the minimal value may not be smaller than 37D
- Pachymetry data for 7-8 mm zone are not available.
- Corneal disease or pathology, such as corneal scaring or opacity, that precludes transmission of laser wavelength or that distorts laser light
- 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.
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 |
|---|---|---|
| Laser-assisted Astigmatic keratotomyLaser-assisted Astigmatic keratotomy are performed by the VICTUS™ Femtosecond Laser Platform. | Device | Astigmatic keratotomy |
Primary outcome
Keratomic corneal astigmatism
Time frame: The study endpoints will be calculated for the 3-Months follow-up examination.
The postoperative keratomic corneal astigmatism is in 60% of all eyes equal or better than 1.0D
1 secondary outcome
Topographic corneal and subjective cylinder
Time frame: This end point is measured at the 3 Months Follow Up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2014.
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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 principal investigator
Gemini clinic, Zlin
Pavel Stodulka, Dr. med 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?
A Phase 4 study testing Laser-assisted Astigmatic keratotomy in people with 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 20 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: finished, as of the sponsor's last update on 2 Jun 2014. 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.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Keratomic corneal astigmatism (time frame: The study endpoints will be calculated for the 3-Months follow-up examination.). 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 2 Jun 2014.