MyopiaPhase 1NCT01556893

Creating LASIK Flaps With the LenSx Femtosecond Laser

A Phase 1 study testing LenSx Laser in people with Myopia and Hyperopia, run by Alcon LenSx, Inc. at 1 site in Hungary.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This will be a prospective, single-center clinical trial of up to 50 eyes of subjects scheduled to undergo LASIK surgery requiring an initial corneal flap. Subjects will be screened for eligibility. Subjects will undergo LASIK surgery using the LenSx Laser to create the corneal flap prior to excimer laser treatment. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Myopia, Hyperopia
What is being tested?: LenSx Laser
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteHungary
Study dates: Apr 2012to Mar 2013
Phase: Phase 1
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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Must have myopia or hyperopia eligible for femtosecond initiated LASIK surgery
Must be over 18 years of age
Must have visual acuity correctable to at least 20/25 in both eyes
If subject is a contact lens wearer, discontinuation of contact lens wear prior to preoperative exam (2 weeks prior for soft contact lenses, 4 weeks prior for rigid gas permeable contact lenses, and 8 weeks prior for hard contact lenses)
Must be willing and able to return for scheduled follow up examinations through 3 months after surgery
Must sign and be given a copy of the written Informed Consent form
Postoperative refractive target is emmetropia

Who cannot join

Known sensitivity to planned study concomitant medications
Participation in any other ophthalmic drug or device clinical trial during the time of this clinical investigation
Presenting any contraindications to femtosecond initiated LASIK
Corneal thickness values that will result in residual bed less than 280 microns when flap resection and excimer ablation are calculated
Irregular astigmatism, based on Investigator's judgment
Undergoing monovision LASIK
Pregnant, lactating or plan to become pregnant during the course of this study
For bilateral second study eyes only: The surgeon shall not proceed with the second eye until the 1 week exam of the first eye shows no vision threatening complications.

Trial locations and contacts

1 site in 1 country.

Hungary1 site

Department of Ophthalmology, Semmelweis University
Budapest, 1085

Other trials in Hungary

About this study

Official title: Prospective, Single-center Clinical Trial of Subjects Scheduled to Undergo LASIK Surgery Requiring an Initial Corneal Flap.

This will be a prospective, single-center clinical trial of up to 50 eyes of subjects scheduled to undergo LASIK surgery requiring an initial corneal flap. Subjects will be screened for eligibility.

Subjects will undergo LASIK surgery using the LenSx Laser to create the corneal flap prior to excimer laser treatment.

Subjects will be evaluated intraoperatively to assess the ease of lifting the flaps, the stromal bed quality, and the amount of opaque bubble layer. All patients will be followed with routine vision exams for 3 months postoperatively to evaluate changes in visual acuity, manifest refraction, slit lamp examination, and endothelial cell counts.

Conditions: Myopia, Hyperopia
Being tested: LenSx Laser
Keywords: Flap Creation, Femtosecond Laser, corneal flap prior to LASIK procedure
Medical subject headings: Myopia, Hyperopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LenSx LaserDevice
The LenSx laser system is a femtosecond laser that has received 510(k) clearance for anterior capsulotomy during cataract surgery (K082947), laser phacofragmentation during cataract surgery (K094052) and for use in the creation of a single and multi-plane arc cut/incisions in the cornea (K092647).

Study groups in NCT01556893
Study group	Role	What they receive
LASIK Flap Arm	Other	This is a single arm study. Receives: Device: LenSx Laser

What is being measured

The primary outcome is the main question the study is designed to answer.

Ease of Lifting Flaps
0 - Unable to lift flap
1. - Able to lift flap with aid of sharp instrument
2. - Able to lift flap with difficulty using blunt instrument
3. - Able to lift flap with moderate resistance using blunt instrument
4. - Able to lift flap with minimal resistance using blunt instrument
5. - Able to lift flap without any resistance using blunt instrument (Scale)
Measured: Operative

Secondary outcomes (1)

Stromal Bed Quality
0 - very rough
1- moderately rough 2 - rough 3 - smooth 4 - moderately smooth 5 - very smooth (Scale)
Measured: Operative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2012Mar 2013

First posted19 Mar 2012 (estimated)
Study startApr 2012
Primary completionMar 2013
Study completionMar 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for MyopiaStudies 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 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01556893
Sponsor's protocol ID: CS-004f
Status last verified: Oct 2014
First submitted: 15 Mar 2012
Last updated: 27 Oct 2014
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective, Single-center Clinical Trial of Subjects Scheduled to Undergo LASIK Surgery Requiring an Initial Corneal Flap.
ClinicalTrials.gov ID: NCT01556893
Acronym / sponsor ID: CS-004f
Conditions: Myopia, Hyperopia
Keywords: Flap Creation, Femtosecond Laser, corneal flap prior to LASIK procedure
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Alcon LenSx, Inc.Industry (pharma, biotech, devices)
Study start: Apr 2012
Primary completion: Mar 2013 (actual)
Study completion: Mar 2013 (actual)
First posted: 19 Mar 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.

This will be a prospective, single-center clinical trial of up to 50 eyes of subjects scheduled to undergo LASIK surgery requiring an initial corneal flap. Subjects will be screened for eligibility.

Subjects will undergo LASIK surgery using the LenSx Laser to create the corneal flap prior to excimer laser treatment.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
LASIK Flap Arm	Other	Device: LenSx LaserThis is a single arm study.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Must have myopia or hyperopia eligible for femtosecond initiated LASIK surgery
Must be over 18 years of age
Must have visual acuity correctable to at least 20/25 in both eyes
If subject is a contact lens wearer, discontinuation of contact lens wear prior to preoperative exam (2 weeks prior for soft contact lenses, 4 weeks prior for rigid gas permeable contact lenses, and 8 weeks prior for hard contact lenses)
Must be willing and able to return for scheduled follow up examinations through 3 months after surgery

Key exclusion criteria (8 listed)

Known sensitivity to planned study concomitant medications
Participation in any other ophthalmic drug or device clinical trial during the time of this clinical investigation
Presenting any contraindications to femtosecond initiated LASIK
Corneal thickness values that will result in residual bed less than 280 microns when flap resection and excimer ablation are calculated
Irregular astigmatism, based on Investigator's judgment

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
LenSx LaserThe LenSx laser system is a femtosecond laser that has received 510(k) clearance for anterior capsulotomy during cataract surgery (K082947), laser phacofragmentation during cataract surgery (K094052) and for use in the creation of a single and multi-plane arc cut/incisions in the cornea (K092647).	Device	LASIK Flap Arm

Primary outcome

Ease of Lifting Flaps
Time frame: Operative
0 - Unable to lift flap 1. - Able to lift flap with aid of sharp instrument 2. - Able to lift flap with difficulty using blunt instrument 3. - Able to lift flap with moderate resistance using blunt instrument 4. - Able to lift flap with minimal resistance using blunt instrument 5. - Able to lift flap without any resistance using blunt instrument (Scale)

1 secondary outcome

Stromal Bed Quality
Time frame: Operative

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 27 Oct 2014.

Related trials for Myopia

Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LenSx Laser in people with Myopia and Hyperopia, run by Alcon LenSx, Inc. at 1 site in Hungary.

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 7 inclusion and 8 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 27 Oct 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 Hungary. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Ease of Lifting Flaps (time frame: Operative). 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 NCT01556893.

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 27 Oct 2014.