AstigmatismNCT01752218
A Study to Address Precision and Refractive Predictability of Femtosecond Laser-assisted Astigmatic Keratotomy Following the Cataract Surgery
A study testing arcuate incision in people with Astigmatism, run by Technolas Perfect Vision GmbH at 1 site in Germany.
Trial summary
The purpose of this open, prospective study is to address the effectiveness and precision of the VICTUS™ Femtosecond Laser Platform-assisted astigmatic keratotomy after femtolaser-assisted cataract surgery. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Astigmatism
- What is being tested?
- arcuate incision
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2013to Apr 2014
- Phase
- Interventional
- 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
- Clear corneal media
- Patients must be at least 40 years of age
- mono- or bilateral Cataract with uncorrected distance visual acuity (UCDVA)
- 0.63 or glare sensitivity
- Vectorial averaged astigmatism of keratometric and topographic astigmatism:
- 1.0 D and ≤ 2.0 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 does not include examination results at an radius of 4.25 mm
- 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: A Single Centre Study to Address Precision and Refractive Predictability of Femtosecond Laser-assisted Astigmatic Keratotomy Following the Cataract Surgery
The purpose of this open, prospective study is to address the effectiveness and precision of the VICTUS™ Femtosecond Laser Platform-assisted astigmatic keratotomy after femtolaser-assisted cataract surgery.
Read the detailed description
Corneal astigmatism after cataract surgery represents a considerable obstacle in the visual rehabilitation of patients. Up-to-date astigmatic keratotomy represents a standardized and effective procedure that allows decreasing of naturally occurring and surgically induced astigmatism. The shape and architecture of the Arcuate Incisions are pre-calculated based on a particular chosen nomogram. The different parameters of the Arcuate Incisions as radius, opening and position angle and cutting depth can be achieved precisely by the laser technology.
The laser-assisted Cataract surgery and the Arcuate Incisions are performed by means of a femtosecond laser (VICTUS™ FEMTOSECOND LASER PLATFORM®, Technolas Perfect Vision GmbH, Munich, Germany) which is in the presented study under investigation and is already CE-approved.
For this open, prospective data collection several selection criteria have been defined in order to obtain a data set of minimal 43 eyes and maximal 50 eyes. Depending on whether they will be treated unilateral or bilateral the number of subjects enrolled within this study sums up to 22-50 patients. The data is gathered in the Castrop-Rauxel Augenklinik and only from one experienced surgeon.
- Conditions
- Astigmatism
- Being tested
- arcuate incision
- Keywords
- Femto-second Laser, arcuate incision, corneal astigmatism, astigmatic keratotomy, Cataract
- Medical subject headings
- Astigmatism, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arcuate incisionDevice
| Study group | Role | What they receive |
|---|---|---|
| Arcuate Incision | Experimental | Study arm will consist of patients who show cataract and corneal astigmatism. Receives: Device: arcuate incision |
What is being measured
The primary outcome is the main question the study is designed to answer.
subjective cylinder
At the 3 month visit the subjective cylinder as measured with phoropter or trial frame is ≤ 0.75 D in 60% of the eyes.
Measured: 3 month postoperative
Secondary outcomes (5)
topographic corneal cylinder
At the 3 month visit the value of postoperative corneal astigmatism of the central 3 mm zone, measured with topography, is ≤ 1.0 D in 60% of the eyes
Measured: 3 month postoperative
abberrometric corneal astigmatism
At the 3 month visit the value of postoperative corneal astigmatism of the central 3 mm zone, measured with aberrometry, is ≤ 1.0 D in 60% of the eyes.
Measured: 3 month postoperative
keratomic corneal astigmatism
At the 3 month visit the value of postoperative corneal astigmatism of the central 3 mm zone, measured with keratometry, is ≤ 1.0 D in 60% of the eyes
Measured: 3 month postoperative
correction index based on keratometric corneal astigmatism
At 3 month visit the value of the correction index based on preoperative and postoperative keratometric corneal astigmatism is 0.9+- 0,35 in 70% of the eyes.
Measured: 3 month postoperative
correction index based on
At 3 month visit the value of the correction index based on preoperative keratometric corneal astigmatism and postoperative subjective astigmatism is 0.9+- 0,35 in 70% of the eyes.
Measured: 3 month postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2012 (estimated)
- Study startJan 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technolas Perfect Vision GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Hoffmann, Dr., Principal investigator, Augen- & Laserklinik Castrop-Rauxel GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01752218
- Sponsor's protocol ID
- 1209
- Status last verified
- May 2014
- First submitted
- 14 Dec 2012
- Last updated
- 22 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Wendelstein JA, Hoffmann PC, Schwarzenbacher L, Fischinger IR, Hirnschall N, Menapace R, Langenbucher A, Findl O, Bolz M. Lasting Effects: Seven Year Results of the Castrop Nomogram for Femtosecond Laser-Assisted Paired Corneal Arcuate Incisions. Curr Eye Res. 2022 Feb;47(2):225-232. doi: 10.1080/02713683.2021.1975761. Epub 2021 Sep 7.
PubMed 34464547
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Centre Study to Address Precision and Refractive Predictability of Femtosecond Laser-assisted Astigmatic Keratotomy Following the Cataract Surgery
- ClinicalTrials.gov ID
- NCT01752218
- Acronym / sponsor ID
- 1209
- Conditions
- Astigmatism
- Keywords
- Femto-second Laser, arcuate incision, corneal astigmatism, astigmatic keratotomy, Cataract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Technolas Perfect Vision GmbHIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 19 Dec 2012 (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.
The purpose of this open, prospective study is to address the effectiveness and precision of the VICTUS™ Femtosecond Laser Platform-assisted astigmatic keratotomy after femtolaser-assisted cataract surgery.
Detailed description
Corneal astigmatism after cataract surgery represents a considerable obstacle in the visual rehabilitation of patients. Up-to-date astigmatic keratotomy represents a standardized and effective procedure that allows decreasing of naturally occurring and surgically induced astigmatism. The shape and architecture of the Arcuate Incisions are pre-calculated based on a particular chosen nomogram. The different parameters of the Arcuate Incisions as radius, opening and position angle and cutting depth can be achieved precisely by the laser technology.
The laser-assisted Cataract surgery and the Arcuate Incisions are performed by means of a femtosecond laser (VICTUS™ FEMTOSECOND LASER PLATFORM®, Technolas Perfect Vision GmbH, Munich, Germany) which is in the presented study under investigation and is already CE-approved.
For this open, prospective data collection several selection criteria have been defined in order to obtain a data set of minimal 43 eyes and maximal 50 eyes. Depending on whether they will be treated unilateral or bilateral the number of subjects enrolled within this study sums up to 22-50 patients. The data is gathered in the Castrop-Rauxel Augenklinik and only from one experienced surgeon.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arcuate Incision | Experimental | Device: arcuate incisionStudy arm will consist of patients who show cataract and corneal astigmatism. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Clear corneal media
- Patients must be at least 40 years of age
- mono- or bilateral Cataract with uncorrected distance visual acuity (UCDVA)
- Vectorial averaged astigmatism of keratometric and topographic astigmatism:
- 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 does not include examination results at an radius of 4.25 mm
- 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 |
|---|---|---|
| arcuate incision | Device | Arcuate Incision |
Primary outcome
subjective cylinder
Time frame: 3 month postoperative
At the 3 month visit the subjective cylinder as measured with phoropter or trial frame is ≤ 0.75 D in 60% of the eyes.
5 secondary outcomes
topographic corneal cylinder
Time frame: 3 month postoperative
abberrometric corneal astigmatism
Time frame: 3 month postoperative
keratomic corneal astigmatism
Time frame: 3 month postoperative
correction index based on keratometric corneal astigmatism
Time frame: 3 month postoperative
correction index based on
Time frame: 3 month postoperative
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 22 May 2014.
- Derived from this study: PubMed 34464547Wendelstein JA, Hoffmann PC, Schwarzenbacher L, Fischinger IR, Hirnschall N, Menapace R, Langenbucher A, Findl O, Bolz M. Lasting Effects: Seven Year Results of the Castrop Nomogram for Femtosecond Laser-Assisted Paired Corneal Arcuate Incisions. Curr Eye Res. 2022 Feb;47(2):225-232. doi: 10.1080/02713683.2021.1975761. Epub 2021 Sep 7.
- Sponsor: Technolas Perfect Vision GmbHLink provided by the sponsor.
- Investigator's sideLink provided by the sponsor.
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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.
Peter Hoffmann, Dr. principal investigator
Augen- & Laserklinik Castrop-Rauxel GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing arcuate incision in people with Astigmatism, run by Technolas Perfect Vision GmbH at 1 site in Germany.
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 8 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 22 May 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 Germany. 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?
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?
subjective cylinder (time frame: 3 month postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01752218, which also lists 1 linked publication.
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 22 May 2014.