Completed
A Prospective Study to Evaluate the Safety and Effectiveness of Wavefront-Guided Lasik Correction of Hyperopic Refractive Errors With the iDesign Advanced Wavescan Studio™ System and Star S4 IR™ Excimer Laser System
What is being tested
LASIK correction of hyperopic refractive errors
Device
Who is being recruted
Eye Diseases
+ Refractive Errors
+ Hyperopia
Over 18 Years
+11 Eligibility Criteria
How is the trial designed
Treatment Study
Interventional
Study Start: December 2012
Summary
Principal SponsorAbbott Medical Optics
Last updated: December 15, 2021
Sourced from a government-validated database.Claim as a partner
Study start date: December 31, 2012
Actual date on which the first participant was enrolled.Demonstrate that wavefront-guided LASIK using measurements from the iDesign System is safe and effective for the treatment of Hyperopia.
Principal SponsorAbbott Medical Optics
Last updated: December 15, 2021
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
167 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Eye DiseasesRefractive ErrorsHyperopia
Criteria
5 inclusion criteria required to participate
Anticipated post-operative stromal bed thickness of at least 250 microns
At least 18 years of age at the time of pre-operative exam
Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better
Demonstration of refractive stability
Show More Criteria
6 exclusion criteria prevent from participating
Concurrent use of topical or systemic medications that may impair healing
Evidence of keratoconus, corneal irregularity, or abnormal topography in the operative eye(s)
History of any medical conditions that could affect wound healing
History of prior intraocular or corneal surgery, active ophthalmic disease, or other ocular abnormality
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 9 locations
University of Miami Bascom Palmer Eye Institute
Miami, United StatesKraff Eye Institute
Chicago, United StatesPepose Vision Institute
Chesterfield, United StatesCompleted9 Study Centers