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CompletedNCT00365677Updated Dec 8, 2011

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

An interventional study of The Bausch & Lomb Zyoptix Tissue Saving Aspheric algorithm and The Bausch & Lomb Zyoptix Tissue Saving algorithm in Myopia and Astigmatism, sponsored by Bausch & Lomb Incorporated. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-12-08.

Sponsored by Bausch & Lomb Incorporated · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
127
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

02

Conditions studied

  • Myopia
  • Astigmatism

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03

In context

Myopia

984 studies on the registry are indexed under Myopia; 210 are open to participants now.

This study's enrollment of 127 is above the median of 80 across 783 interventional studies indexed under Myopia.

Browse Myopia studies →

Lead sponsor

Bausch & Lomb Incorporated is the lead sponsor of 219 studies on the registry; 7 are open to participants now.

Of its 49 completed or terminated interventional studies of FDA-regulated products, 41 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Contraindications to LASIK.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
127 participants (actual)

Study arms

  • Experimental
    Zyoptix Tissue Saving Aspheric

    The Bausch \& Lomb Zyoptix Tissue Saving Aspheric algorithm is used for treatment with LASIK for the correction of myopia and myopic astigmatism.

    Device: The Bausch & Lomb Zyoptix Tissue Saving Aspheric algorithm

  • Active comparator
    Zyoptix Tissue Saving

    The Bausch \& Lomb Zyoptix Tissue Saving algorithm is used for treatment with LASIK for the correction of myopia and myopic astigmatism.

    Device: The Bausch & Lomb Zyoptix Tissue Saving algorithm

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.

06

What researchers measure

Primary outcomes

  1. Uncorrected visual acuity

    Time frame: At 90 days post surgery

  2. Preservation of best spectacle corrected high contrast logMAR distance visual acuity compared to baseline.

    Time frame: At 90 days post surgery

Secondary outcomes

  1. Deviation from target correction

    Time frame: At 90 days post surgery

  2. Improvement in uncorrected distance high contrast logMAR visual acuity compared to baseline

    Time frame: At 90 days post surgery

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 8, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00365677
Lead sponsor
Bausch & Lomb Incorporated
Responsible party
Sponsor
First posted
Aug 17, 2006
Start date
Oct 2005
Primary completion
Mar 2006
Completion
Mar 2006
Last update
Dec 8, 2011

Study contacts

Joanne Egamino, PhD
study director · Bausch & Lomb Incorporated

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2011. You cannot join it, but the record below documents what was studied.

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