NCT00348205

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 30, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 4, 2006

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
11.5 years until next milestone

Results Posted

Study results publicly available

September 14, 2020

Completed
Last Updated

September 14, 2020

Status Verified

September 1, 2020

Enrollment Period

3.6 years

First QC Date

June 30, 2006

Results QC Date

August 11, 2020

Last Update Submit

September 10, 2020

Conditions

HyperopiaAstigmatism

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (1)

  • Loss of Best Spectacle-corrected Visual Acuity (BSCVA)

    24 months

Study Arms (1)

Technolas 217z Zyoptix System

EXPERIMENTAL

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

Device: Technolas 217z Zyoptix Laser

Interventions

Technolas 217z Zyoptix LaserDEVICE

Technolas 217z Zyoptix System with Treatment Planner Customized Treatment Calculation Software for the wavefront-guided LASIK treatment of hyperopia and hyperoptic astigmatism.

Technolas 217z Zyoptix System

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hyperopia with or without astigmatism.

You may not qualify if:

  • Contraindications to LASIK.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bausch & Lomb

Rochester, New York, 14609, United States

Location

MeSH Terms

Conditions

HyperopiaAstigmatism

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Results Point of Contact

Title
Study Director
Organization
Bausch Health
susan.harris@bauschhealth.com
908-300-9920

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2006

First Posted

July 4, 2006

Study Start

June 1, 2005

Primary Completion

January 1, 2009

Study Completion

March 1, 2009

Last Updated

September 14, 2020

Results First Posted

September 14, 2020

Record last verified: 2020-09

Locations

US(1)