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

Abbott

Status: Completed

Conditions: Hyperopia

Treatments: Device: LASIK correction of hyperopic refractive errors

Study type: Interventional

Funder types: Industry

Identifiers

NCT01675479

STAR-111-IDHP

Details and patient eligibility

About

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

Enrollment: 167 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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167 participants in 1 patient group

wavefront-guided LASIK

Experimental group

Treatment:

Device: LASIK correction of hyperopic refractive errors