MyopiaNCT00769808

Technolas 217z Laser With Zyoptix Aspheric Algorithm Used for the LASIK Treatment of Myopia and Myopic Astigmatism.

A study testing Bausch & Lomb 217z Excimer Laser in people with Myopia and Astigmatism, run by Bausch & Lomb Incorporated at 1 site in Canada.

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 safety and effectiveness of the Bausch \& Lomb Technolas 217z laser with the investigational Zyoptix Aspheric Algorithm when used for LASIK treatment of myopia and myopic astigmatism. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Myopia, Astigmatism
What is being tested?: Bausch & Lomb 217z Excimer Laser
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 72 participants
Where: 1 siteCanada
Study dates: Aug 2008to Mar 2010
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects who were of legal age (at least 18) and had full legal capacity to volunteer.
Subjects must be willing to have both eyes treated with the laser.
Subjects must have up to -12.00D of absolute spherical myopia (not spherical equivalent) with up to -6.00D of refractive astigmatism, with a spherical equivalent up to -15.00D as measured by manifest subjective refraction.
Subjects who had less than 0.75 D of difference in the preoperative manifest spherical equivalent and cycloplegic spherical equivalent subjective refractions.
(Manifest subjective refractions adjusted for optical infinity were used.)
High contrast, manifest best spectacle-corrected distance logMAR visual acuity correctable to at least 0.3 in both eyes, and must not differ between eyes by more than 1 line (5 letters).
Contact lens wearers must have 2 Orbscan measurements and 2 manifest subjective refractions taken preoperatively at least 1 week apart.
Contact lens wearers must have gas permeable lenses discontinued for at least 3 weeks and soft lenses discontinued for at least 2 weeks prior to the preoperative evaluation.

Who cannot join

Subjects with uncorrected visual acuity better than 20/40 (Snellen) or 0.3 logMAR
Subjects who were immuno-compromised or had a diagnosis of connective tissue disease, clinically significant atopic disease, diabetes, autoimmune diseases and other acute or chronic illnesses that increased the risk to the subject or could have confounded the outcomes of this study.
Subjects with uncontrolled glaucoma or glaucoma who were under treatment in the study eye or with ocular hypertension.
Subjects who demonstrated evidence of retinal vascular disease.
Subjects who have an ocular muscle disorder including strabismus or nystagmus, or other disorders that affected fixation.
Subjects who were at risk for angle closure or who had a potentially occludable angle, as evidenced by a shallow anterior chamber on slit lamp exam, confirmed by gonioscopy as deemed necessary by the study Investigator.

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Subjects who had undergone previous intraocular or corneal surgery of any kind, including any type of excimer laser surgery for either refractive or therapeutic purposes.
Subjects who were taking systemic medications likely to affect wound healing such as corticosteroids or anti-metabolites or any other medications that may increase the risk to the subject or confound the outcomes of this study.
Subjects for whom the combination of their preoperative corneal thickness and the planned operative parameters for the LASIK procedure could have resulted in less than 250 microns of remaining posterior corneal thickness below the flap postoperatively.

Trial locations and contacts

1 site in 1 country.

Canada1 site

Lasik MD, 130 King Street
Toronto, Ontario, M5X1C8

Other trials in Canada

About this study

Official title: A Prospective Trial to Evaluate the Safety and Effectiveness of the Bausch & Lomb Technolas® 217z Laser With Zyoptix® Aspheric Algorithm When Used for the LASIK Treatment of Myopia and Myopic Astigmatism

Conditions: Myopia, Astigmatism
Being tested: Bausch & Lomb 217z Excimer Laser
Medical subject headings: Myopia, Astigmatism

What participants receive

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

Bausch & Lomb 217z Excimer LaserDevice
LASIK correction of myopia and myopic astigmatism

Study groups in NCT00769808
Study group	Role	What they receive
Technolas 217z Excimer Laser	Experimental	Bausch \& Lomb Zyoptix Aspheric Algorithm for LASIK correction of myopia and myopic astigmatism. Receives: Device: Bausch & Lomb 217z Excimer Laser

What is being measured

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

Percentage of Eyes With Uncorrected High Contrast Distance Visual Acuity of 20/40 or Better
Measured: 3 months
Percentage of Eyes With Manifest Subjective Refraction (MRSE) Within ± 1.00 Diopter (D) and 0.50 D of Emmetropia
Manifest refractions (eyeglass prescriptions) have three components: sphere, cylinder, and axis. Sphere and cylinder are both expressed in diopters, which is a continuous measure of the focusing power needed to make the image sharp on the retina. Manifest refraction spherical equivalent (MRSE) is equal to sphere + ½ x cylinder. It is expressed in diopters (D).
Measured: 3 months
Preservation of Manifest Best Corrected High Contrast Distance Visual Acuity
Mean change in best-corrected high contrast distance visual acuity. Corrected means spectacle corrected. Visual acuity (VA) was reported as letters read correctly, and the letters read were converted to logarithm of the minimum angle of resolution (logMAR) acuity. The participant read rows of letters on a standard LogMAR chart until the participant misses 3 letters on a row with 5 letters. The total number of correct letters were recorded. A decrease in the number of correct letters indicates a decrease in visual acuity. Acuity was averaged across visits.
Measured: Baseline, 3 months
Percentage of Eyes With Manifest Best-corrected Distance Photopic Visual Acuity Decrease of 2 or More Lines
Measured: 3 months
Percentage of Eyes With > 2.00 Diopter of Induced Postoperative Refractive Cylinder
Manifest refractions (eyeglass prescriptions) have three components: sphere, cylinder, and axis. Sphere and cylinder are both expressed in diopters, which is a continuous measure of the focusing power needed to make the image sharp on the retina. Manifest refraction spherical equivalent (MRSE) is equal to sphere + ½ x cylinder. It is expressed in diopters (D).
Measured: 3 months
Percentage of Eyes That Had High Contrast Best Spectacle Corrected Visual Acuity (HCBSCVA) of 20/20 or Better at Baseline Had a Visual Outcome Worse Than 20/40 at 3 Months
Corrected means spectacle corrected. Visual acuity (VA) was reported as letters read correctly, and the letters read were converted to logarithm of the minimum angle of resolution (logMAR) acuity. The participant read rows of letters on a standard LogMAR chart until the participant misses 3 letters on a row with 5 letters. The total number of correct letters were recorded. A decrease in the number of correct letters indicates a decrease in visual acuity. Acuity was averaged across visits.
Measured: 3 months

Secondary outcomes (1)

Percentage Change From Baseline in Higher Order Aberrations.
The aberrations in the eye's optical system were measured over the entire pupil by the Bausch \& Lomb Zywave II WaveFront Aberrometer, a Hartmann-Shack type device. The pupil should have been at least 6 mm in diameter using 2.5% phenylephrine as a dilating agent to maximize the pupil diameter and hence the amount of wavefront information collected by the Zywave II. The wavefront data was then fitted with Zernike polynomials representing the 2nd, 3rd, 4th and 5th order Zernike terms. These terms represent the wavefront aberration of the eye.
Measured: Baseline, 3 months

Timeline

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

Aug 2008Mar 2010

First posted9 Oct 2008 (estimated)
Study startAug 2008
Primary completionMar 2010
Study completionMar 2010

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.
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
Model description: This was a medical device study with only one intervention used for lasik correction surgery
Masking: None (open label)
Enrolment: 72 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00769808
Sponsor's protocol ID: 564
Status last verified: Aug 2020
First submitted: 8 Oct 2008
Last updated: 11 Sep 2020
Results posted: Yes, on ClinicalTrials.gov
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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RecruitingPhase 3
A RCT of Spectacles With Aspherical Lenslets or 0.05% Atropine for Myopia Control
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Recruiting
Evaluation of Orthokeratology Lenses With a 5MM Optic Zone Diameter
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SmoothCore Orthokeratology Plus M.O.V.E. Lenses vs. M.O.V.E. Lenses Alone for Myopia Control in Children With High Myopia
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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective Trial to Evaluate the Safety and Effectiveness of the Bausch & Lomb Technolas® 217z Laser With Zyoptix® Aspheric Algorithm When Used for the LASIK Treatment of Myopia and Myopic Astigmatism
ClinicalTrials.gov ID: NCT00769808
Acronym / sponsor ID: 564
Conditions: Myopia, Astigmatism
Study type: Interventional
Recruitment status: Completed
Enrolment: 72 participants (actual)
Lead sponsor: Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
Study start: Aug 2008
Primary completion: Mar 2010 (actual)
Study completion: Mar 2010 (actual)
First posted: 9 Oct 2008 (estimated)
Results: Posted 11 Sep 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: This was a medical device study with only one intervention used for lasik correction surgery

Arm	Type	Receives
Technolas 217z Excimer Laser	Experimental	Device: Bausch & Lomb 217z Excimer LaserBausch \& Lomb Zyoptix Aspheric Algorithm for LASIK correction of myopia and myopic astigmatism.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Subjects who were of legal age (at least 18) and had full legal capacity to volunteer.
Subjects must be willing to have both eyes treated with the laser.
Subjects must have up to -12.00D of absolute spherical myopia (not spherical equivalent) with up to -6.00D of refractive astigmatism, with a spherical equivalent up to -15.00D as measured by manifest subjective refraction.
Subjects who had less than 0.75 D of difference in the preoperative manifest spherical equivalent and cycloplegic spherical equivalent subjective refractions.
(Manifest subjective refractions adjusted for optical infinity were used.)

Key exclusion criteria (9 listed)

Subjects with uncorrected visual acuity better than 20/40 (Snellen) or 0.3 logMAR
Subjects who were immuno-compromised or had a diagnosis of connective tissue disease, clinically significant atopic disease, diabetes, autoimmune diseases and other acute or chronic illnesses that increased the risk to the subject or could have confounded the outcomes of this study.
Subjects with uncontrolled glaucoma or glaucoma who were under treatment in the study eye or with ocular hypertension.
Subjects who demonstrated evidence of retinal vascular disease.
Subjects who have an ocular muscle disorder including strabismus or nystagmus, or other disorders that affected fixation.

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
Bausch & Lomb 217z Excimer LaserLASIK correction of myopia and myopic astigmatism	Device	Technolas 217z Excimer Laser

Primary outcome

Percentage of Eyes With Uncorrected High Contrast Distance Visual Acuity of 20/40 or Better
Time frame: 3 months
Percentage of Eyes With Manifest Subjective Refraction (MRSE) Within ± 1.00 Diopter (D) and 0.50 D of Emmetropia
Time frame: 3 months
Manifest refractions (eyeglass prescriptions) have three components: sphere, cylinder, and axis. Sphere and cylinder are both expressed in diopters, which is a continuous measure of the focusing power needed to make the image sharp on the retina. Manifest refraction spherical equivalent (MRSE) is equal to sphere + ½ x cylinder. It is expressed in diopters (D).
Preservation of Manifest Best Corrected High Contrast Distance Visual Acuity
Time frame: Baseline, 3 months
Mean change in best-corrected high contrast distance visual acuity. Corrected means spectacle corrected. Visual acuity (VA) was reported as letters read correctly, and the letters read were converted to logarithm of the minimum angle of resolution (logMAR) acuity. The participant read rows of letters on a standard LogMAR chart until the participant misses 3 letters on a row with 5 letters. The total number of correct letters were recorded. A decrease in the number of correct letters indicates a decrease in visual acuity. Acuity was averaged across visits.
Percentage of Eyes With Manifest Best-corrected Distance Photopic Visual Acuity Decrease of 2 or More Lines
Time frame: 3 months
Percentage of Eyes With > 2.00 Diopter of Induced Postoperative Refractive Cylinder
Time frame: 3 months
Manifest refractions (eyeglass prescriptions) have three components: sphere, cylinder, and axis. Sphere and cylinder are both expressed in diopters, which is a continuous measure of the focusing power needed to make the image sharp on the retina. Manifest refraction spherical equivalent (MRSE) is equal to sphere + ½ x cylinder. It is expressed in diopters (D).
Percentage of Eyes That Had High Contrast Best Spectacle Corrected Visual Acuity (HCBSCVA) of 20/20 or Better at Baseline Had a Visual Outcome Worse Than 20/40 at 3 Months
Time frame: 3 months
Corrected means spectacle corrected. Visual acuity (VA) was reported as letters read correctly, and the letters read were converted to logarithm of the minimum angle of resolution (logMAR) acuity. The participant read rows of letters on a standard LogMAR chart until the participant misses 3 letters on a row with 5 letters. The total number of correct letters were recorded. A decrease in the number of correct letters indicates a decrease in visual acuity. Acuity was averaged across visits.

1 secondary outcome

Percentage Change From Baseline in Higher Order Aberrations.
Time frame: Baseline, 3 months

Results and safety

Results posted to the registry on 11 Sep 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Technolas 217z Excimer Laser	72	64

Primary outcome: Percentage of Eyes With Uncorrected High Contrast Distance Visual Acuity of 20/40 or Better

Time frame: 3 months. Number (95% Confidence Interval). Unit: percentage of eyes

Measure	Technolas 217z Excimer Laser n = 59
Value	99.2 (97.5 to 100)

Population analysed: There were 59 participants with visual acuity data available for analysis.

Primary outcome: Percentage of Eyes With Manifest Subjective Refraction (MRSE) Within ± 1.00 Diopter (D) and 0.50 D of Emmetropia

Time frame: 3 months. Count of units. Unit: eyes

Measure	Technolas 217z Excimer Laser n = 59
Within 0.50 D	109
Within 1.00 D	117

Primary outcome: Preservation of Manifest Best Corrected High Contrast Distance Visual Acuity

Time frame: Baseline, 3 months. Mean (Standard Deviation). Unit: units on a scale

Measure	Technolas 217z Excimer Laser n = 59
Value	-0.055 (0.103)

Primary outcome: Percentage of Eyes With Manifest Best-corrected Distance Photopic Visual Acuity Decrease of 2 or More Lines

Time frame: 3 months. Count of units. Unit: eyes

Measure	Technolas 217z Excimer Laser n = 59
Value	1

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Technolas 217z Excimer Laser	0 of 66 (0%)	51 of 66 (77.3%)	0 of 66

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Myopia

Not yet recruiting
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Active, not recruitingPhase 4
Odyssey Evaluation in Post LASIK Patients
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RecruitingPhase 3
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Not yet recruiting
SmoothCore Orthokeratology Plus M.O.V.E. Lenses vs. M.O.V.E. Lenses Alone for Myopia Control in Children With High Myopia
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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.

Mark Cohen, MD principal investigator

Lasik MD

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

Questions about this trial

What is this clinical trial studying?

A study testing Bausch & Lomb 217z Excimer Laser in people with Myopia and Astigmatism, run by Bausch & Lomb Incorporated at 1 site in Canada.

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 9 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 11 Sep 2020. 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 Canada. 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 11 Sep 2020). 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?

Percentage of Eyes With Uncorrected High Contrast Distance Visual Acuity of 20/40 or Better (time frame: 3 months). The study lists 6 primary outcomes in all. 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 NCT00769808.

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 11 Sep 2020.