A Study to Investigate the Safety and Effectiveness of Aspheric Laser Refractive Surgery Treatments for Myopia

Compare the Safety and Effectiveness of Two Versions of the Bausch & Lomb Zyoptix™ Tissue Saving Aspheric Algorithm to the Current Zyoptix™ Tissue Saving Algorithm When Used for Myopia and Myopic Astigmatism Lasik Treatment

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00365677

Enrollment

127

Registered

2006-08-17

Start date

2005-10-31

Completion date

2006-03-31

Last updated

2011-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Astigmatism, Myopia

Brief summary

The objective of this study was to compare the safety and effectiveness of two versions of the Bausch & Lomb Zyoptix Tissue Saving Aspheric Algorithm versus the current Zyoptix Tissue Saving Algorithm when used for myopia and myopic astigmatism LASIK treatment.

Interventions

DEVICEThe Bausch & Lomb Zyoptix Tissue Saving Aspheric algorithm

Used with LASIK treatment for the correction of myopia and myopic astigmatism.

DEVICEThe Bausch & Lomb Zyoptix Tissue Saving algorithm

Used with LASIK treatment for the correction of myopia and myopic astigmatism.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Myopia with or without astigmatism. * Normal Corneal topography * Willing to have both eyes treated with the laser.

Exclusion criteria

* Contraindications to LASIK.

Design outcomes

Primary

Measure	Time frame
Uncorrected visual acuity	At 90 days post surgery
Preservation of best spectacle corrected high contrast logMAR distance visual acuity compared to baseline.	At 90 days post surgery

Secondary

Measure	Time frame
Deviation from target correction	At 90 days post surgery
Improvement in uncorrected distance high contrast logMAR visual acuity compared to baseline	At 90 days post surgery

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026