N/A N=80 Treatment

A Study to Evaluate the Safety and Effectiveness of the Technols 217z Zyoptix System for Hyperopia

Hyperopia · Astigmatism

Bottom Line

View on ClinicalTrials.gov: NCT00348205 ↗

Enrolled (actual)

Serious AEs

1.3%

Results posted

Sep 2020

Primary outcome: Primary: Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better at 12 Months and 24 Months — 147; 140 eyes

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Technolas 217z Zyoptix Laser (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Bausch & Lomb Incorporated
Primary completion: Jan 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better at 12 Months and 24 Months	147; 140	—
PRIMARY Percentage of Eyes With a Postoperative Subjective Manifest Refraction Spherical Equivalent (MRSE) Within ± 1.00 Diopter (D) and ± 0.50 D of Emmetropia.	100; 142	—
PRIMARY The Percentage of Eyes With a Postoperative Subjective Manifest Refraction Spherical Equivalent (MRSE) Within ± 1.00 Diopter (D) and ± 0.50 D of Emmetropia	97; 129	—
PRIMARY Refractive Stability - Categorical Change Between Month 1 and Month 3	135	—
PRIMARY Refractive Stability - Mean Change Between Month 1 and Month 3	0.12	—
PRIMARY Induced Astigmatism	—	—
SECONDARY Loss of Best Spectacle-corrected Visual Acuity (BSCVA)	1; 3	—

Summary

A study to demonstrate the safety and effectiveness of wavefront laser refractive surgery treatments for hyperopia and astigmatism.

Eligibility Criteria

Inclusion Criteria

Hyperopia with or without astigmatism.

Exclusion Criteria

Contraindications to LASIK.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00348205). 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.