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OpenTrials
Completed

NCT Number: NCT00365677

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

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.

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Key information

Conditions

Myopia Astigmatism Eye Diseases Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Contraindications to LASIK.

Treatment and study plan

The Bausch & Lomb Zyoptix Tissue Saving Aspheric algorithm

Device

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

The Bausch & Lomb Zyoptix Tissue Saving algorithm

Device

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

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

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Aug 17, 2006
Registry last updated
Dec 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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