Trial Outcomes & Findings for Technolas 217z Laser With Zyoptix Aspheric Algorithm Used for the LASIK Treatment of Myopia and Myopic Astigmatism. (NCT NCT00769808)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

72 participants

Primary outcome timeframe

3 months

Results posted on

2020-09-11

Participant Flow

Seventy two myopic participants (144 eyes) were enrolled.

Participant milestones

Participant milestones
Measure	Technolas 217z Excimer Laser Bausch \& Lomb Zyoptix Aspheric Algorithm for LASIK correction of myopia and myopic astigmatism. Bausch \& Lomb 217z Excimer Laser: LASIK correction of myopia and myopic astigmatism
Overall Study STARTED	72
Overall Study COMPLETED	64
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Technolas 217z Excimer Laser n=65 Participants Bausch \& Lomb Zyoptix Aspheric Algorithm for LASIK correction of myopia and myopic astigmatism. Bausch \& Lomb 217z Excimer Laser: LASIK correction of myopia and myopic astigmatism
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	65 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	32.0 years STANDARD_DEVIATION 7.1 • n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	21 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	40 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

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

Outcome measures

Outcome measures
Measure	Technolas 217z Excimer Laser n=59 Participants Bausch \& Lomb Zyoptix Aspheric Algorithm for LASIK correction of myopia and myopic astigmatism. Bausch \& Lomb 217z Excimer Laser: LASIK correction of myopia and myopic astigmatism
Percentage of Eyes With Uncorrected High Contrast Distance Visual Acuity of 20/40 or Better	99.2 percentage of eyes Interval 97.5 to 100.0

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Technolas 217z Excimer Laser n=118 eyes Bausch \& Lomb Zyoptix Aspheric Algorithm for LASIK correction of myopia and myopic astigmatism. Bausch \& Lomb 217z Excimer Laser: LASIK correction of myopia and myopic astigmatism
Percentage of Eyes With Manifest Subjective Refraction (MRSE) Within ± 1.00 Diopter (D) and 0.50 D of Emmetropia Within 0.50 D	109 eyes
Percentage of Eyes With Manifest Subjective Refraction (MRSE) Within ± 1.00 Diopter (D) and 0.50 D of Emmetropia Within 1.00 D	117 eyes

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Technolas 217z Excimer Laser n=118 eyes Bausch \& Lomb Zyoptix Aspheric Algorithm for LASIK correction of myopia and myopic astigmatism. Bausch \& Lomb 217z Excimer Laser: LASIK correction of myopia and myopic astigmatism
Preservation of Manifest Best Corrected High Contrast Distance Visual Acuity	-0.055 units on a scale Standard Deviation 0.103

PRIMARY outcome

Timeframe: 3 months

Outcome measures

Outcome measures
Measure	Technolas 217z Excimer Laser n=118 eyes Bausch \& Lomb Zyoptix Aspheric Algorithm for LASIK correction of myopia and myopic astigmatism. Bausch \& Lomb 217z Excimer Laser: LASIK correction of myopia and myopic astigmatism
Percentage of Eyes With Manifest Best-corrected Distance Photopic Visual Acuity Decrease of 2 or More Lines	1 eyes

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Technolas 217z Excimer Laser n=118 eyes Bausch \& Lomb Zyoptix Aspheric Algorithm for LASIK correction of myopia and myopic astigmatism. Bausch \& Lomb 217z Excimer Laser: LASIK correction of myopia and myopic astigmatism
Percentage of Eyes With > 2.00 Diopter of Induced Postoperative Refractive Cylinder	0 eyes

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Technolas 217z Excimer Laser n=118 eyes Bausch \& Lomb Zyoptix Aspheric Algorithm for LASIK correction of myopia and myopic astigmatism. Bausch \& Lomb 217z Excimer Laser: LASIK correction of myopia and myopic astigmatism
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	0 eyes

SECONDARY outcome

Timeframe: Baseline, 3 months

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.

Outcome measures

Outcome measures
Measure	Technolas 217z Excimer Laser n=118 eyes Bausch \& Lomb Zyoptix Aspheric Algorithm for LASIK correction of myopia and myopic astigmatism. Bausch \& Lomb 217z Excimer Laser: LASIK correction of myopia and myopic astigmatism
Percentage Change From Baseline in Higher Order Aberrations.	24.9 Percentage change Standard Deviation 0.1413

Adverse Events

Technolas 217z Excimer Laser

Serious events: 0 serious events

Other events: 51 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Technolas 217z Excimer Laser n=66 participants at risk Bausch \& Lomb Zyoptix Aspheric Algorithm for LASIK correction of myopia and myopic astigmatism. Bausch \& Lomb 217z Excimer Laser: LASIK correction of myopia and myopic astigmatism
Eye disorders Bowman's membrane disorder	12.1% 8/66 • 6 months There were 66 treated participants evaluated for adverse events.
Eye disorders Corneal edema	6.1% 4/66 • 6 months There were 66 treated participants evaluated for adverse events.
Eye disorders Keratitis	24.2% 16/66 • 6 months There were 66 treated participants evaluated for adverse events.
Eye disorders Punctate keratitis	54.5% 36/66 • 6 months There were 66 treated participants evaluated for adverse events.
Eye disorders Eye operation complication	31.8% 21/66 • 6 months There were 66 treated participants evaluated for adverse events.

Additional Information

Study Director

Bausch & Lomb Incorporated

Phone: 9083009926

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER