Peripheral PresbyLASIK Using the Allegretto Wavelight System For The Treatment of Presbyopia
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|ClinicalTrials.gov Identifier: NCT01059006|
Recruitment Status : Withdrawn (Lead researcher completed fellowship and never got study off ground)
First Posted : January 29, 2010
Last Update Posted : August 5, 2011
|Condition or disease||Intervention/treatment||Phase|
|Refractive Error Presbyopia||Procedure: PresbyLASIK||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Peripheral PresbyLASIK Using the Allegretto Wavelight System For The Treatment of Presbyopia|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||July 2010|
|Actual Study Completion Date :||July 2010|
Male or female patients with presbyopic symptoms who underwent PresbyLASIK.
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.
- Uncorrected near visual acuity [ Time Frame: 1 Day, 1 Week, 3 and 6 Months ]
- Best corrected near visual acuity [ Time Frame: 1 Day, 1 Week, 3 and 6 Months ]
- Intermediate visual acuity [ Time Frame: 1 Day, 1 Week, 3 and 6 Months ]
- Stereoacuity test [ Time Frame: 1 Day, 1 Week, 3 and 6 Months ]
- Psychometric questionnaire [ Time Frame: 1 Day, 1 Week, 3 and 6 Months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01059006
|Principal Investigator:||David J Schanzlin, MD||UCSD Shiley Eye Center|