Clinical Investigation of the WaveLight® EX500 Excimer Laser
NCT ID: NCT04805593
Last Updated: 2024-08-21
Study Results
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View full resultsBasic Information
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COMPLETED
NA
44 participants
INTERVENTIONAL
2021-04-28
2023-05-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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WaveLight EX500 excimer laser system
Laser-assisted in situ keratomileusis (LASIK) surgery using the WaveLight EX500 excimer laser system
WaveLight EX500 excimer laser system
FDA approved stationary scanning-spot excimer laser system used during refractive surgery for the treatment of myopia, myopic astigmatism, hyperopia, hyperopic astigmatism, and mixed astigmatism. For this clinical study, the Wavefront Optimized (WFO) Ablation profile of the WaveLight EX500 excimer laser system will be used for bilateral LASIK treatment of hyperopia with and without astigmatism.
LASIK
Procedure that reshapes the front part of the eye (cornea) so that light traveling through it is properly focused on the back part of the eye (retina). The procedure will be performed using the WaveLight EX500 excimer laser system.
Interventions
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WaveLight EX500 excimer laser system
FDA approved stationary scanning-spot excimer laser system used during refractive surgery for the treatment of myopia, myopic astigmatism, hyperopia, hyperopic astigmatism, and mixed astigmatism. For this clinical study, the Wavefront Optimized (WFO) Ablation profile of the WaveLight EX500 excimer laser system will be used for bilateral LASIK treatment of hyperopia with and without astigmatism.
LASIK
Procedure that reshapes the front part of the eye (cornea) so that light traveling through it is properly focused on the back part of the eye (retina). The procedure will be performed using the WaveLight EX500 excimer laser system.
Eligibility Criteria
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Inclusion Criteria
* Hyperopia with or without astigmatism as specified in the protocol;
* Stable vision as specified in the protocol;
Exclusion Criteria
* Cataracts;
* Previous eye surgery;
* Intent to have monovision treatment;
18 Years
ALL
No
Sponsors
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Alcon Research
INDUSTRY
Responsible Party
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Principal Investigators
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Sr. Clinical Trial Lead, Surgical
Role: STUDY_DIRECTOR
Alcon Research, LLC
Locations
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Durrie Vision
Overland Park, Kansas, United States
Moyes Eye Center
Kansas City, Missouri, United States
Physicians Protocol
Greensboro, North Carolina, United States
Vance Thompson Vision ND
West Fargo, North Dakota, United States
Mann Eye Institute
Houston, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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RFD530-P001
Identifier Type: -
Identifier Source: org_study_id
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