Peripheral PresbyLASIK Using the Allegretto Wavelight System For The Treatment of Presbyopia

Presbyopia Clinical Trial

Official title: Peripheral PresbyLASIK Using the Allegretto Wavelight System For The Treatment of Presbyopia

Status Withdrawn

Clinical Trial Summary

The aim of this study is to analyze the results of PresbyLASIK performed using the wavefront-optimized LASIK for the treatment of presbyopia on low hyperopic and low myopic patients with astigmatism. Visual performance will be assessed using clinical outcome measures of the following: refraction, near, intermediate and distance visual acuity, stereoacuity and contrast sensitivity. Questionnaires will also be used to evaluate how the patient's vision is before and after surgery.

Clinical Trial Description

Presbyopia is a physiologic change related to age in which there is reduction in the eye's ability to focus in order to obtain clear vision for near distance. At approximately age 40 the range of accommodation begins to decrease and there is a diminishing capacity of the eye to focus on the nearest point it can focus on. This makes the need for corrective lenses a necessity in order to read at near as well as focus at an intermediate distance.

Presbyopia correction is one of the most frequently discussed topics in refractive surgery today. The idea of a creating a multifocal cornea using refractive surgery has sparked tremendous interest in finding a solution for this growing population throughout the world, especially amongst surgeons and the ophthalmic industry

PresbyLASIK essentially involves the creation of a multifocal surface able to correct any visual defect for distance while simultaneously allowing freedom from near spectacle dependency in presbyopic patients. PresbyLASIK is currently being offered routinely to patients in the San Diego area, across the country as well as in numerous centers around the world.

Conclusions from this study would serve as a guide for keratorefractive surgeons, who are pursuing peripheral PresbyLASIK, in determining the preoperative patient features in order to achieve the best outcome using the Wavelight-Allegretto System. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Presbyopia
• Refractive Error
• Refractive Errors

• NCT number: NCT01059006
• Study type: Interventional
• Source: University of California, San Diego
• Status: Withdrawn
• Phase: N/A
• Start date: January 2010
• Completion date: July 2010