Safety and Effectiveness of Wavefront-Guided LASIK Correction of Hyperopic Refractive Errors

Hyperopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01675479
• Other study ID #: STAR-111-IDHP
• Status: Completed
• Phase: N/A
• Start date: December 31, 2012
• Est. completion date: October 31, 2016

Study information

• Verified date: December 2021
• Source: Abbott Medical Optics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Demonstrate that wavefront-guided LASIK using measurements from the iDesign System is safe and effective for the treatment of Hyperopia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 167
• Est. completion date: October 31, 2016
• Est. primary completion date: October 31, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

• Anticipated post-operative stromal bed thickness of at least 250 microns

• Willing and capable of returning for follow-up examinations for the duration of the study

Exclusion Criteria:

• Women who are pregnant, breast-feeding, or intend to become pregnant over the course of the study

• Concurrent use of topical or systemic medications that may impair healing

• History of any medical conditions that could affect wound healing

• History of prior intraocular or corneal surgery, active ophthalmic disease, or other ocular abnormality

• Evidence of keratoconus, corneal irregularity, or abnormal topography in the operative eye(s)

• Known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course

Related Conditions & MeSH terms

• Hyperopia
• Refractive Errors

Intervention

Device:
• LASIK correction of hyperopic refractive errors
Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System

Locations

Country	Name	City	State
United States	Coleman Vision	Albuquerque	New Mexico
United States	Pepose Vision Institute	Chesterfield	Missouri
United States	Kraff Eye Institute	Chicago	Illinois
United States	The Eye Center	Fairfax	Virginia
United States	Durrie Vision	Kansas City	Missouri
United States	Maloney Vision Institute	Los Angeles	California
United States	University of Miami Bascom Palmer Eye Institute	Miami	Florida
United States	Lehmann Eye Center	Nacogdoches	Texas
United States	King LASIK	Renton	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Optics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Eyes With a Loss of >2 Lines for Best Spectacle Corrected Visual Acuity (BSCVA)	Hypothesis: <5% of eyes will have a loss of > 2 lines of BSCVA at any postoperative visit, as measured using ETDRS logMAR visual acuity charts at 4 meters	12 Months
Secondary	Number of Eyes With Uncorrected Visual Acuity (VA) of 20/40 or Better	Hypothesis: 85% of eyes will have uncorrected visual acuity of 20/40 or better, as measured using ETDRS logMAR charts at 4 meters	12 Months