N/A
Completed N=80
A Study to Evaluate the Safety and Effectiveness of the Technols 217z Zyoptix System for Hyperopia
Hyperopia · Astigmatism
Source: ClinicalTrials.gov NCT00348205 ↗
Enrolled (actual)
80
Serious AEs
1.3%
Results posted
Sep 2020
Primary outcomePrimary: Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better at 12 Months and 24 Months — 147; 140 eyes
Summary
A study to demonstrate the safety and effectiveness of wavefront laser refractive surgery treatments for hyperopia and astigmatism.
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 | — |
Eligibility Criteria
Inclusion Criteria
- Hyperopia with or without astigmatism.
Exclusion Criteria
- Contraindications to LASIK.
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. Informational only — not medical advice.