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

Study Overview
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Brief Summary
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A study to demonstrate the safety and effectiveness of wavefront laser refractive surgery treatments for hyperopia and astigmatism.

Conditions
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Hyperopia, Astigmatism

Intervention / Treatment
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* Device: Technolas 217z Zyoptix Laser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hyperopia with or without astigmatism. Exclusion Criteria: Contraindications to LASIK.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Technolas 217z Zyoptix System<br>Bausch & Lomb Technolas 217z Zyoptix System with Treatment Planner Customized Treatment Calculation Software. | Device: Technolas 217z Zyoptix Laser<br>* Technolas 217z Zyoptix System with Treatment Planner Customized Treatment Calculation Software for the wavefront-guided LASIK treatment of hyperopia and hyperoptic astigmatism.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better at 12 Months and 24 Months |  | 24 months | 
| Percentage of Eyes With a Postoperative Subjective Manifest Refraction Spherical Equivalent (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). | 12 months | 
| The Percentage of Eyes With a Postoperative Subjective Manifest Refraction Spherical Equivalent (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). | 24 months | 
| Refractive Stability - Categorical Change Between Month 1 and Month 3 | 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). | Month 1, Month 3 | 
| Refractive Stability - Mean Change Between Month 1 and Month 3 | 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). | 1 month, 3 months | 
| Induced Astigmatism | Percentage of eyes which had >2.00 Diopter of induced refractive cylinder for those eyes treated for spherical hyperopia only. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Loss of Best Spectacle-corrected Visual Acuity (BSCVA) | 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. | 24 months |