MyopiaPhase 3NCT01673503
A Prospective Study of Femtosecond Laser Intracorneal Lensectomi
A Phase 3 study testing Carl Zeiss Meditech VisuMax laser in people with Myopia and Astigmatism, run by Odense University Hospital at 1 site in Denmark.
Trial summary
The purpose of this study is to compare visual acuity, safety, predictability, corneal biomechanics, dry eyes, and nerve-morphology after all femtosecond laser refractive lenticule extraction. Read more about this study
- Who is it for?
- Ages 25 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia, Astigmatism
- What is being tested?
- Carl Zeiss Meditech VisuMax laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteDenmark
- Study dates
- May 2011to not given
- Phase
- Phase 3
- 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 25 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 25 to 45 years,
- moderate to high myopia with astigmatism =< 2 D,
- otherwise eye healthy,
- CDVA of 0.8 or better (Snellen).
Who cannot join
- systemic or ocular disease or previous eye surgery,
- thin cornea,
- a difference of more than 2 D myopia in the eyes of each subject.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Ophthalmology Aarhus Sygehus - Aarhus University Hospital, Denmark
Aarhus, 8000
About this study
Official title: A Prospective Study of Femtosecond Laser Intracorneal Lensectomi in Treatment of Moderate to High Myopia
The purpose of this study is to compare visual acuity, safety, predictability, corneal biomechanics, dry eyes, and nerve-morphology after all femtosecond laser refractive lenticule extraction. Approximately 30 to 40 patients with moderate to high myopia will randomly (after ocular dominance) receive ReLEx flex in one eye, and ReLEx smile in the other.
- Conditions
- Myopia, Astigmatism
- Being tested
- Carl Zeiss Meditech VisuMax laser
- Keywords
- Myopia, refractive surgery, all femtosecond laser, ReLEx flex, ReLEx smile
- Medical subject headings
- Myopia, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carl Zeiss Meditech VisuMax laserDevice
Also called Refractive lenticule extraction, ReLEx
Refractive lenticule extraction (ReLEx) with the Carl Zeiss Meditech VisuMax laser
| Study group | Role | What they receive |
|---|---|---|
| Carl Zeiss Meditech VisuMax laser - ReLEx flex | Active comparator | >30 patients will receive treatment for myopia with a VisuMax femtosecond laser from Carl Zeiss. The laser can cut with two different settings, called ReLEx flex and ReLEx smile. One eye will recieve ReLEx flex, and the other ReLEx smile Receives: Device: Carl Zeiss Meditech VisuMax laser |
| Carl Zeiss Meditech VisuMax laser - ReLEx smile | Active comparator | >30 patients will receive treatment for myopia with a VisuMax femtosecond laser from Carl Zeiss. The laser can cut with two different settings, called ReLEx flex and ReLEx smile. One eye will recieve ReLEx flex, and the other ReLEx smile Receives: Device: Carl Zeiss Meditech VisuMax laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
Using ETDRS charts, both uncorrected and corrected distance visual acuity, along with visual acuity using the FrACT contrast chart
Measured: up to 6 months
Secondary outcomes (1)
refractive predictability
Optometrists measure refraction at follow-up-examinations, and the refraction 6 monhts after surgery will be compared to the target refraction to calculate refractive predictability
Measured: Pre-surgery, 1 week, 1 month, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2012 (estimated)
- Study startMay 2011
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 MyopiaStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 35 participants
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Principal investigator, Anders H. Vestergaard, University of Southern Denmark
- Investigators
- Anders H Vestergaard, MD, Principal investigator, Odense University Hospital, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01673503
- Sponsor's protocol ID
- S-20100111
- Status last verified
- Jan 2013
- First submitted
- 20 Aug 2012
- Last updated
- 24 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Vestergaard AH, Gronbech KT, Grauslund J, Ivarsen AR, Hjortdal JO. Subbasal nerve morphology, corneal sensation, and tear film evaluation after refractive femtosecond laser lenticule extraction. Graefes Arch Clin Exp Ophthalmol. 2013 Nov;251(11):2591-600. doi: 10.1007/s00417-013-2400-x. Epub 2013 Jun 22.
PubMed 23793872
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Femtosecond Laser Intracorneal Lensectomi in Treatment of Moderate to High Myopia
- ClinicalTrials.gov ID
- NCT01673503
- Acronym / sponsor ID
- S-20100111
- Conditions
- Myopia, Astigmatism
- Keywords
- Myopia, refractive surgery, all femtosecond laser, ReLEx flex, ReLEx smile
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- May 2011
- First posted
- 28 Aug 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 study is to compare visual acuity, safety, predictability, corneal biomechanics, dry eyes, and nerve-morphology after all femtosecond laser refractive lenticule extraction. Approximately 30 to 40 patients with moderate to high myopia will randomly (after ocular dominance) receive ReLEx flex in one eye, and ReLEx smile in the other.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carl Zeiss Meditech VisuMax laser - ReLEx flex | Active comparator | Device: Carl Zeiss Meditech VisuMax laser>30 patients will receive treatment for myopia with a VisuMax femtosecond laser from Carl Zeiss. The laser can cut with two different settings, called ReLEx flex and ReLEx smile. One eye will recieve ReLEx flex, and the other ReLEx smile |
| Carl Zeiss Meditech VisuMax laser - ReLEx smile | Active comparator | Device: Carl Zeiss Meditech VisuMax laser>30 patients will receive treatment for myopia with a VisuMax femtosecond laser from Carl Zeiss. The laser can cut with two different settings, called ReLEx flex and ReLEx smile. One eye will recieve ReLEx flex, and the other ReLEx smile |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 25 to 45 years,
- moderate to high myopia with astigmatism =< 2 D,
- otherwise eye healthy,
- CDVA of 0.8 or better (Snellen).
Key exclusion criteria (3 listed)
- systemic or ocular disease or previous eye surgery,
- thin cornea,
- a difference of more than 2 D myopia in the eyes of each subject.
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 |
|---|---|---|
| Carl Zeiss Meditech VisuMax laserAlso: Refractive lenticule extraction, ReLExRefractive lenticule extraction (ReLEx) with the Carl Zeiss Meditech VisuMax laser | Device | Carl Zeiss Meditech VisuMax laser - ReLEx flex, Carl Zeiss Meditech VisuMax laser - ReLEx smile |
Primary outcome
Visual acuity
Time frame: up to 6 months
Using ETDRS charts, both uncorrected and corrected distance visual acuity, along with visual acuity using the FrACT contrast chart
1 secondary outcome
refractive predictability
Time frame: Pre-surgery, 1 week, 1 month, 3 months, 6 months
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 24 Jan 2013.
- Derived from this study: PubMed 23793872Vestergaard AH, Gronbech KT, Grauslund J, Ivarsen AR, Hjortdal JO. Subbasal nerve morphology, corneal sensation, and tear film evaluation after refractive femtosecond laser lenticule extraction. Graefes Arch Clin Exp Ophthalmol. 2013 Nov;251(11):2591-600. doi: 10.1007/s00417-013-2400-x. Epub 2013 Jun 22.
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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.
Anders H Vestergaard, MD principal investigator
Odense University Hospital, University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Carl Zeiss Meditech VisuMax laser in people with Myopia and Astigmatism, run by Odense University Hospital at 1 site in Denmark.
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 4 inclusion and 3 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 24 Jan 2013. 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 Denmark. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Visual acuity (time frame: up to 6 months). 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 NCT01673503, 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 24 Jan 2013.