Trial Outcomes & Findings for A Study to Evaluate the Safety and Effectiveness of the Technols 217z Zyoptix System for Hyperopia (NCT NCT00348205)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

80 participants

Primary outcome timeframe

24 months

Results posted on

2020-09-14

Participant Flow

Participant milestones

Participant milestones
Measure	Technolas 217z Zyoptix System Bausch \& Lomb Technolas 217z Zyoptix System with Treatment Planner Customized Treatment Calculation Software. Technolas 217z Zyoptix Laser: Technolas 217z Zyoptix System with Treatment Planner Customized Treatment Calculation Software for the wavefront-guided LASIK treatment of hyperopia and hyperoptic astigmatism.
Overall Study STARTED	80
Overall Study COMPLETED	78
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Evaluate the Safety and Effectiveness of the Technols 217z Zyoptix System for Hyperopia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Technolas 217z Zyoptix System n=159 eyes Bausch \& Lomb Technolas 217z Zyoptix System with Treatment Planner Customized Treatment Calculation Software. Technolas 217z Zyoptix Laser: Technolas 217z Zyoptix System with Treatment Planner Customized Treatment Calculation Software for the wavefront-guided LASIK treatment of hyperopia and hyperoptic astigmatism.
Age, Continuous	49.5 years STANDARD_DEVIATION 8.7 • n=5 Participants
Sex: Female, Male Female	45 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 months

Population: The number of eyes available for uncorrected visual acuity assessment at 12 months and 24 months were included in the analysis.

Outcome measures

Outcome measures
Measure	Technolas 217z Zyoptix System n=147 eyes Bausch \& Lomb Technolas 217z Zyoptix System with Treatment Planner Customized Treatment Calculation Software. Technolas 217z Zyoptix Laser: Technolas 217z Zyoptix System with Treatment Planner Customized Treatment Calculation Software for the wavefront-guided LASIK treatment of hyperopia and hyperoptic astigmatism.
Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better at 12 Months and 24 Months 12 months	147 eyes
Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better at 12 Months and 24 Months 24 months	140 eyes

PRIMARY outcome

Timeframe: 12 months

Population: The number of eyes available for manifest refraction spherical equivalent assessment at 12 months were included in the analysis.

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 Zyoptix System n=147 eyes Bausch \& Lomb Technolas 217z Zyoptix System with Treatment Planner Customized Treatment Calculation Software. Technolas 217z Zyoptix Laser: Technolas 217z Zyoptix System with Treatment Planner Customized Treatment Calculation Software for the wavefront-guided LASIK treatment of hyperopia and hyperoptic astigmatism.
Percentage of Eyes With a Postoperative Subjective Manifest Refraction Spherical Equivalent (MRSE) Within ± 1.00 Diopter (D) and ± 0.50 D of Emmetropia. Within 0.50 D	100 eyes
Percentage of Eyes With a Postoperative Subjective Manifest Refraction Spherical Equivalent (MRSE) Within ± 1.00 Diopter (D) and ± 0.50 D of Emmetropia. Within 1.00 D	142 eyes

PRIMARY outcome

Timeframe: 24 months

Population: The number of eyes available for manifest refraction spherical equivalent assessment at 24 months were included in the analysis.

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 Zyoptix System n=143 eyes Bausch \& Lomb Technolas 217z Zyoptix System with Treatment Planner Customized Treatment Calculation Software. Technolas 217z Zyoptix Laser: Technolas 217z Zyoptix System with Treatment Planner Customized Treatment Calculation Software for the wavefront-guided LASIK treatment of hyperopia and hyperoptic astigmatism.
The Percentage of Eyes With a Postoperative Subjective Manifest Refraction Spherical Equivalent (MRSE) Within ± 1.00 Diopter (D) and ± 0.50 D of Emmetropia Within 0.50 D	97 eyes
The Percentage of Eyes With a Postoperative Subjective Manifest Refraction Spherical Equivalent (MRSE) Within ± 1.00 Diopter (D) and ± 0.50 D of Emmetropia Within 1.00 D	129 eyes

PRIMARY outcome

Timeframe: Month 1, Month 3

Population: There were 139 eyes with manifest refraction spherical equivalent assessments at both Month 1 and Month 3 for this outcome assessment.

Percentage of eyes with a change of ≤ 1.00 Diopter in manifest refraction spherical equivalent (MRSE) between postoperative refractions, performed at 1 months and 3 months after surgery. 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 Zyoptix System n=139 eyes Bausch \& Lomb Technolas 217z Zyoptix System with Treatment Planner Customized Treatment Calculation Software. Technolas 217z Zyoptix Laser: Technolas 217z Zyoptix System with Treatment Planner Customized Treatment Calculation Software for the wavefront-guided LASIK treatment of hyperopia and hyperoptic astigmatism.
Refractive Stability - Categorical Change Between Month 1 and Month 3	135 eyes

PRIMARY outcome

Timeframe: 1 month, 3 months

Population: There were 139 eyes with manifest refraction spherical equivalent assessments at both Month 1 and Month 3 for this outcome assessment.

Mean change in manifest refraction spherical equivalent (MRSE) between postoperative refractions, performed at 1 months and 3 months after surgery. 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 Zyoptix System n=139 eyes Bausch \& Lomb Technolas 217z Zyoptix System with Treatment Planner Customized Treatment Calculation Software. Technolas 217z Zyoptix Laser: Technolas 217z Zyoptix System with Treatment Planner Customized Treatment Calculation Software for the wavefront-guided LASIK treatment of hyperopia and hyperoptic astigmatism.
Refractive Stability - Mean Change Between Month 1 and Month 3	0.12 diopter Standard Deviation 0.40

PRIMARY outcome

Timeframe: 24 months

Population: There were 32 sphere eyes assessed for this outcome measure.

Percentage of eyes which had \>2.00 Diopter of induced refractive cylinder for those eyes treated for spherical hyperopia only.

Outcome measures

Outcome measures
Measure	Technolas 217z Zyoptix System n=32 eyes Bausch \& Lomb Technolas 217z Zyoptix System with Treatment Planner Customized Treatment Calculation Software. Technolas 217z Zyoptix Laser: Technolas 217z Zyoptix System with Treatment Planner Customized Treatment Calculation Software for the wavefront-guided LASIK treatment of hyperopia and hyperoptic astigmatism.
Induced Astigmatism	0 eyes

SECONDARY outcome

Timeframe: 24 months

Population: The number of eyes available for uncorrected visual acuity assessment at 12 months and 24 months were included in the analysis.

Percentage of eyes with loss of best spectacle corrected visual acuity (BSCVA) of \>2 lines. 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 Zyoptix System n=155 eyes Bausch \& Lomb Technolas 217z Zyoptix System with Treatment Planner Customized Treatment Calculation Software. Technolas 217z Zyoptix Laser: Technolas 217z Zyoptix System with Treatment Planner Customized Treatment Calculation Software for the wavefront-guided LASIK treatment of hyperopia and hyperoptic astigmatism.
Loss of Best Spectacle-corrected Visual Acuity (BSCVA) 12 months	1 eyes
Loss of Best Spectacle-corrected Visual Acuity (BSCVA) 24 months	3 eyes

Adverse Events

Technolas 217z Zyoptix System

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Technolas 217z Zyoptix System n=80 participants at risk Bausch \& Lomb Technolas 217z Zyoptix System with Treatment Planner Customized Treatment Calculation Software. Technolas 217z Zyoptix Laser: Technolas 217z Zyoptix System with Treatment Planner Customized Treatment Calculation Software for the wavefront-guided LASIK treatment of hyperopia and hyperoptic astigmatism.
Injury, poisoning and procedural complications Suction break	1.2% 1/80 • 24 months Adverse events (AEs) were assessed throughout the study. AEs were not coded (therefore, there is no source vocabulary).

Other adverse events

Adverse event data not reported

Additional Information

Study Director

Bausch Health

Phone: 908-300-9920

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Contact sponsor directly for details.
Publication restrictions are in place

Restriction type: OTHER