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

Not Applicable

Completed

• Conditions: Hyperopia; Astigmatism
• Interventions: Device: Technolas 217z Zyoptix Laser

• Registration Number: NCT00348205
• Lead Sponsor: Bausch & Lomb Incorporated

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2006-06-30
• Study First Submitted QC: 2006-07-03
• Study First Posted: 2006-07-04
• Primary Completion: 2009-01
• Study Completion: 2009-03
• Disposition First Submitted: 2010-04-09
• Disposition First Submitted QC: 2010-04-09
• Disposition First Posted: 2010-04-22
• Results First Submitted: 2020-08-11
• Status Verified: 2020-09
• Results First Submitted QC: 2020-09-10
• Last Update Submitted: 2020-09-10
• Results First Posted: 2020-09-14
• Last Update Posted: 2020-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Hyperopia with or without astigmatism.

Exclusion Criteria

• Contraindications to LASIK.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Technolas 217z Zyoptix System	Technolas 217z Zyoptix Laser	Bausch \& Lomb Technolas 217z Zyoptix System with Treatment Planner Customized Treatment Calculation Software.

Primary Outcome Measures

Name	Time	Method
Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better at 12 Months and 24 Months	24 months
Refractive Stability - Mean Change Between Month 1 and Month 3	1 month, 3 months	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).
Percentage of Eyes With a Postoperative Subjective Manifest Refraction Spherical Equivalent (MRSE) Within ± 1.00 Diopter (D) and ± 0.50 D of Emmetropia.	12 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).
The Percentage of Eyes With a Postoperative Subjective Manifest Refraction Spherical Equivalent (MRSE) Within ± 1.00 Diopter (D) and ± 0.50 D of Emmetropia	24 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).
Refractive Stability - Categorical Change Between Month 1 and Month 3	Month 1, 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).
Induced Astigmatism	24 months	Percentage of eyes which had \>2.00 Diopter of induced refractive cylinder for those eyes treated for spherical hyperopia only.

Secondary Outcome Measures

Name	Time	Method
Loss of Best Spectacle-corrected Visual Acuity (BSCVA)	24 months	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.

Trial Locations

Locations (1)

Bausch & Lomb; 🇺🇸 Rochester, New York, United States