N/A N=69 Treatment

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

Hyperopia

Bottom Line

View on ClinicalTrials.gov: NCT01675479 ↗

Enrolled (actual)

Serious AEs

4.4%

Results posted

Apr 2018

Primary outcome: Primary: Number of Eyes With a Loss of >2 Lines for Best Spectacle Corrected Visual Acuity (BSCVA) — 2 eyes

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: LASIK correction of hyperopic refractive errors (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Abbott Medical Optics
Primary completion: Oct 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Eyes With a Loss of >2 Lines for Best Spectacle Corrected Visual Acuity (BSCVA)	2	—
SECONDARY Number of Eyes With Uncorrected Visual Acuity (VA) of 20/40 or Better	123	—

Summary

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

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01675479). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.