N/A
Completed N=50
Study of Clinical Performance of Corneal Topography Measurement Using an Optical Biometer
Corneal Topography
Source: ClinicalTrials.gov NCT01861925 ↗
Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcomePrimary: In-vivo Repeatability of Corneal Topography Measurements With Lenstar LS 900 Topography: Sample Mean of Differences of Mean Power and Sample Mean of Std. Dev of Local Power Differences Between Two Consecutive Measurements — -0.014; 0.053; -0.120; -0.029 diopters
Summary
The purpose of this study is to quantify in-vivo repeatability of a new corneal topography measurement mode of an optical biometer, and the clinical performance of measurement in comparison to reference devices.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY In-vivo Repeatability of Corneal Topography Measurements With Lenstar LS 900 Topography: Sample Mean of Differences of Mean Power and Sample Mean of Std. Dev of Local Power Differences Between Two Consecutive Measurements |
-0.014; 0.053; -0.120; -0.029; 0.015; -0.089 | — |
| SECONDARY Equivalence of Corneal Topography Measurement Between Lenstar LS 900 Topography and Atlas 9000: Sample Mean of Differences of Mean Power and Sample Mean of Std. Dev of Local Power Differences for One Measurement Per Device. |
0.044; 0.012; 0.160; 0.79; 0.77; 2.49 | — |
Eligibility Criteria
Inclusion Criteria
- 18 years or older
Exclusion Criteria
- No corneal transplants
- No corneal scar(s)
- No acute infections of the eye
- No weak fixation
- No suspected lack of compliance
- No vulnerable population
Data sourced from ClinicalTrials.gov (NCT01861925). 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.