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

NCT01675479 | Completed Results FDA Device

• 1 other identifier: STAR-111-IDHP
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 9

Brief Summary

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

Conditions

Hyperopia

Keywords

refractive; errors

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Eyes With Uncorrected Visual Acuity (VA) of 20/40 or Better

  12 Months

Study Arms (1)

wavefront-guided LASIK

EXPERIMENTAL

Device: LASIK correction of hyperopic refractive errors

Interventions

LASIK correction of hyperopic refractive errors DEVICE

Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System

wavefront-guided LASIK

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Optics: lead

Study Sites (9)

Maloney Vision Institute

Los Angeles, California, 90024, United States

Location

University of Miami Bascom Palmer Eye Institute

Miami, Florida, 33136, United States

Location

Kraff Eye Institute

Chicago, Illinois, 60602, United States

Location

Pepose Vision Institute

Chesterfield, Missouri, 63017, United States

Location

Durrie Vision

Kansas City, Missouri, 66211, United States

Location

Coleman Vision

Albuquerque, New Mexico, 87109, United States

Location

Lehmann Eye Center

Nacogdoches, Texas, 75965, United States

Location

The Eye Center

Fairfax, Virginia, 22031, United States

Location

King LASIK

Renton, Washington, 98057, United States

Location

MeSH Terms

Conditions

Hyperopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Head of Clinical Science
• Organization: Abbott Medical Optics

khileman@its.jnj.com

714-247-8613

Study Officials

• Johnson & Johnson Surgical Vision Clinical Trials

  Johnson & Johnson Surgical Vision

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2012
• First Posted: August 30, 2012
• Study Start: December 31, 2012
• Primary Completion: October 31, 2016
• Study Completion: October 31, 2016
• Last Updated: December 15, 2021
• Results First Posted: April 25, 2018

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)