Clinical trial NCT00769808: Technolas 217z Laser With Zyoptix Aspheric Algorithm Used for the LASIK Treatment of Myopia and Myopic Astigmatism.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Astigmatism
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2008-10-09
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This was a medical device study with only one intervention used for lasik correction surgery
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion

* 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.
* 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.

Primary outcomes:
measure: Percentage of Eyes With Uncorrected High Contrast Distance Visual Acuity of 20/40 or Better
timeFrame: 3 months
measure: Percentage of Eyes With Manifest Subjective Refraction (MRSE) Within ± 1.00 Diopter (D) and 0.50 D of Emmetropia
timeFrame: 3 months
measure: Preservation of Manifest Best Corrected High Contrast Distance Visual Acuity
timeFrame: Baseline, 3 months
measure: Percentage of Eyes With Manifest Best-corrected Distance Photopic Visual Acuity Decrease of 2 or More Lines
timeFrame: 3 months
measure: Percentage of Eyes With > 2.00 Diopter of Induced Postoperative Refractive Cylinder
timeFrame: 3 months
measure: 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
timeFrame: 3 months
Secondary outcomes:
measure: Percentage Change From Baseline in Higher Order Aberrations.
timeFrame: Baseline, 3 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Lasik MD, 130 King Street
state: Ontario
Study officials:
affiliation: Lasik MD
name: Mark Cohen, MD
role: PRINCIPAL_INVESTIGATOR
References: