MyopiaNCT02575911

Accuracy of LASIK Flaps Created With the LenSx® Femtosecond Laser - A Pilot Study

A study testing Femtosecond Laser System and LASIK surgery in people with Myopia and Hyperopia, run by Alcon Research at 1 site in United States.

Completed

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

Official record

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Trial summary

The purpose of this study is to evaluate the thickness accuracy of Laser-assisted in situ keratomileusis (LASIK) flaps created with the LenSx® Laser. Read more about this study

Who is it for?: Ages 22 years and older
Conditions the study is for: Myopia, Hyperopia
What is being tested?: Femtosecond Laser System and LASIK surgery
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 34 participants
Where: 1 siteUnited States
Study dates: 28 Oct 2015to 9 Apr 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 22 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosed with myopia or hyperopia and eligible for femtosecond laser initiated LASIK surgery;
Best corrected visual acuity (BCVA) correctable to at least 20/25 in each eye;
If contact lens wearer, willing to discontinue contact lens wear prior to screening procedures;
Willing and able to return for ALL scheduled follow-up examinations;
Willing and able to provide written informed consent;
Eligible for bilateral LASIK procedures to be done on the same day;
Other protocol-specified inclusion criteria may apply.

Who cannot join

Previous corneal surgery, corneal lesions that will impede laser treatment, corneal edema, hypotony, glaucoma, existing corneal implant, or keratoconus;
Known sensitivity to planned study concomitant medications;
Participation in any other ophthalmic drug or device clinical study for 30 days prior to or during the time of participation in this study;
Irregular astigmatism, based on the Investigator's judgement;
Pregnant, lactating or planning to become pregnant during the course of the study;
Other protocol-specified exclusion criteria may apply.

Trial locations and contacts

1 site in 1 country.

United States1 site

Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, 76134

Other trials in United States

About this study

The purpose of this study is to evaluate the thickness accuracy of Laser-assisted in situ keratomileusis (LASIK) flaps created with the LenSx® Laser.

Conditions: Myopia, Hyperopia
Being tested: Femtosecond Laser System, LASIK surgery
Medical subject headings: Myopia, Hyperopia

What participants receive

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

Femtosecond Laser SystemDevice
Also called LenSx®
Used for the creation of a corneal flap in patients undergoing LASIK surgery
LASIK surgeryProcedure or surgery

Study groups in NCT02575911
Study group	Role	What they receive
LenSx	Experimental	LASIK surgery in both eyes using LenSx® Femtosecond Laser System Receives: Device: Femtosecond Laser System; Procedure: LASIK surgery

What is being measured

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

Flap Thickness Accuracy Within the Central Zone at Month 3 Postoperative
Flap thickness was assessed by optical coherence tomography (OCT) and averaged from 3 separate scans. Flap thickness accuracy was defined as the mean difference between the achieved and desired (desired subtracted from achieved) flap thickness. A positive number represents a postoperative flap thickness that is thicker than the expected flap thickness and vice versa for a negative number. Each eye contributed separately to the analysis.
Measured: Month 3 postoperative

Secondary outcomes (9)

Flap Thickness Accuracy Within the Central Zone at Month 1 Postoperative
Flap thickness was assessed by OCT and averaged from 3 separate scans. Flap thickness accuracy was defined as the mean difference between the achieved and desired (desired subtracted from achieved) flap thickness. A positive number represents a postoperative flap thickness that is thicker than the expected flap thickness and vice versa for a negative number. Each eye contributed separately to the analysis.
Measured: Month 1 postoperative
Flap Thickness Precision Within the Central Zone at Month 1 and Month 3 Postoperative
Flap thickness was assessed by OCT and averaged from 3 separate scans. Flap thickness precision (variability of the achieved flap thickness) was defined as the standard deviation of the flap thickness measurement. Each eye contributed separately to the analysis.
Measured: Month 1, Month 3 postoperative
Ease of Flap Dissection at Day 0, Operative Day
Ease of flap dissection (ease of lifting the flap during surgery) was assessed on a scale from 0 to 5 where 0 = Unable to lift flap and 5 = Able to lift flap without any resistance using blunt instrument. Each eye contributed separately to the analysis.
Measured: Day 0, operative day
Stromal Bed Quality at Day 0, Operative Day
Stromal bed quality was assessed by the investigator on a roughness scale from 0 to 5 where 0 = Very rough surface and 5 = Very smooth surface. Each eye contributed separately to the analysis.
Measured: Day 0, operative day
Opaque Bubble Layer (OBL) at Day 0, Operative Day
Opaque bubble layer was assessed by the investigator during the surgery on a scale from 0 to 5 where 0 = No OBL and 5 = 100% OBL in the stromal bed area. Each eye contributed separately to the analysis.
Measured: Day 0, operative day
Uncorrected Distance Visual Acuity (UCDVA) at Month 1 and Month 3 Postoperative
UCDVA (measurement of uncorrected (without spectacles or other visual corrective devices) distance visual acuity) was assessed at a distance of 6 meters or 20 feet using a standard Snellen eye chart, both monocularly and binocularly, and reported categorically as a percentage of eyes analyzed.
Measured: Month 1, Month 3 postoperative
Best Corrected Distance Visual Acuity (BCDVA) by Visit
BCDVA (measurement with the participant's best spectacle correction) was assessed at a distance of 6 meters or 20 feet using a standard Snellen eye chart, both monocularly and binocularly, and reported categorically as a percentage of eyes analyzed.
Measured: Baseline, Month 1, Month 3 postoperative
Manifest Refraction Spherical Equivalent (MRSE)
The participant was manually refracted to his/her best correction using a phoropter and standard Snellen eye charts. Each eye contributed separately to the analysis.
Measured: Baseline, Month 1, Month 3 postoperative
Prediction Error Between Target Versus Achieved Refraction at One and Three Months Post-op
Prediction error was summarized as a percentage of eyes within 0.5 D and 1.0 D of target at one and three months postoperative
Measured: Month 1, Month 3 postoperative

Timeline

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

28 Oct 20159 Apr 2016

First posted15 Oct 2015 (estimated)
Study start28 Oct 2015
Primary completion9 Apr 2016
Study completion9 Apr 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for MyopiaStudies of the same condition, open and under way.
More trials run by Alcon ResearchThe 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 N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02575911
Sponsor's protocol ID: CTJ121-P001
Status last verified: Apr 2017
First submitted: 13 Oct 2015
Last updated: 2 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

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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Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Accuracy of LASIK Flaps Created With the LenSx® Femtosecond Laser - A Pilot Study
ClinicalTrials.gov ID: NCT02575911
Acronym / sponsor ID: CTJ121-P001
Conditions: Myopia, Hyperopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: 28 Oct 2015 (actual)
Primary completion: 9 Apr 2016 (actual)
Study completion: 9 Apr 2016 (actual)
First posted: 15 Oct 2015 (estimated)
Results: Posted 24 May 2017

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 evaluate the thickness accuracy of Laser-assisted in situ keratomileusis (LASIK) flaps created with the LenSx® Laser.

Study design

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

Arm	Type	Receives
LenSx	Experimental	Device: Femtosecond Laser System, Procedure: LASIK surgeryLASIK surgery in both eyes using LenSx® Femtosecond Laser System

Who may qualify

Ages: 22 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Diagnosed with myopia or hyperopia and eligible for femtosecond laser initiated LASIK surgery;
Best corrected visual acuity (BCVA) correctable to at least 20/25 in each eye;
If contact lens wearer, willing to discontinue contact lens wear prior to screening procedures;
Willing and able to return for ALL scheduled follow-up examinations;
Willing and able to provide written informed consent;

Key exclusion criteria (6 listed)

Previous corneal surgery, corneal lesions that will impede laser treatment, corneal edema, hypotony, glaucoma, existing corneal implant, or keratoconus;
Known sensitivity to planned study concomitant medications;
Participation in any other ophthalmic drug or device clinical study for 30 days prior to or during the time of participation in this study;
Irregular astigmatism, based on the Investigator's judgement;
Pregnant, lactating or planning to become pregnant during the course of the study;

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
Femtosecond Laser SystemAlso: LenSx®Used for the creation of a corneal flap in patients undergoing LASIK surgery	Device	LenSx
LASIK surgery	Procedure or surgery	LenSx

Primary outcome

Flap Thickness Accuracy Within the Central Zone at Month 3 Postoperative
Time frame: Month 3 postoperative
Flap thickness was assessed by optical coherence tomography (OCT) and averaged from 3 separate scans. Flap thickness accuracy was defined as the mean difference between the achieved and desired (desired subtracted from achieved) flap thickness. A positive number represents a postoperative flap thickness that is thicker than the expected flap thickness and vice versa for a negative number. Each eye contributed separately to the analysis.

9 secondary outcomes

Flap Thickness Accuracy Within the Central Zone at Month 1 Postoperative
Time frame: Month 1 postoperative
Flap Thickness Precision Within the Central Zone at Month 1 and Month 3 Postoperative
Time frame: Month 1, Month 3 postoperative
Ease of Flap Dissection at Day 0, Operative Day
Time frame: Day 0, operative day
Stromal Bed Quality at Day 0, Operative Day
Time frame: Day 0, operative day
Opaque Bubble Layer (OBL) at Day 0, Operative Day
Time frame: Day 0, operative day
Uncorrected Distance Visual Acuity (UCDVA) at Month 1 and Month 3 Postoperative
Time frame: Month 1, Month 3 postoperative
Best Corrected Distance Visual Acuity (BCDVA) by Visit
Time frame: Baseline, Month 1, Month 3 postoperative
Manifest Refraction Spherical Equivalent (MRSE)
Time frame: Baseline, Month 1, Month 3 postoperative
Prediction Error Between Target Versus Achieved Refraction at One and Three Months Post-op
Time frame: Month 1, Month 3 postoperative

Results and safety

Results posted to the registry on 24 May 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LenSx	30	29

Primary outcome: Flap Thickness Accuracy Within the Central Zone at Month 3 Postoperative

Time frame: Month 3 postoperative. Mean (Standard Deviation). Unit: micrometers

Measure	LenSx n = 29
Value	125.8 (4.8)

Population analysed: This analysis population includes the number of eyes treated with surgery and data available.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events (AEs) were collected from time of consent for the duration of participation in the study (up to 5 months). AEs are reported as pre-treatment and treatment-emergent. "At Risk" population for ocular AEs is included with unit of "eyes.". Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pre-treatment	0 of 68 (0%)	0 of 68 (0%)	0 of 68
LenSx	1 of 60 (1.7%)	7 of 60 (11.7%)	0 of 60

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Clinical Trial Manager, GCRA study director

Alcon, A Novartis Division

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

Questions about this trial

What is this clinical trial studying?

A study testing Femtosecond Laser System and LASIK surgery in people with Myopia and Hyperopia, run by Alcon Research at 1 site in United States.

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 6 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 Jul 2018. 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 United States. 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?

Yes. Results are posted in the registry (first posted 24 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Flap Thickness Accuracy Within the Central Zone at Month 3 Postoperative (time frame: Month 3 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 NCT02575911.

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 Jul 2018.