Comparability of Keratometry and Intraocular Lens (IOL) Calculation of VERION Image Guided System With Established Measuring Devices in Ophthalmologically Healthy Individuals
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Heidelberg University
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Accuracy of repeatability of keratometry as performed by VERION Image Guided System
Study Overview
Brief Summary
The purpose of this study is to determine if the keratometric functions of the VERION Image Guided System are comparable to those of established keratometric devices (IOLMaster 500, Pentacam HR, LenStar LS900). Calculated intraocular lenses (IOLs) are compared as a clinical consequence of the biometric measurement for IOLMaster 500, LenStar LS900 and VERION Image Guided System.
In addition the comfort and duration of examination in the different devices is evaluated.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •All interested individuals
- •Full legal capacity
Exclusion Criteria
- •Pre-existing or actual ocular disease or pathology, history of ocular surgery
- •Contact lens wear 2 weeks before examination
Arms & Interventions
Opthalmologically healthy individuals
Slit lamp, Autorefractor, IOLMaster 500, Pentacam HR, LenStar LS900, VERION Image Guided System
Intervention: Slit lamp (Device)
Opthalmologically healthy individuals
Slit lamp, Autorefractor, IOLMaster 500, Pentacam HR, LenStar LS900, VERION Image Guided System
Intervention: Autorefractor (Device)
Opthalmologically healthy individuals
Slit lamp, Autorefractor, IOLMaster 500, Pentacam HR, LenStar LS900, VERION Image Guided System
Intervention: IOLMaster 500 (Device)
Opthalmologically healthy individuals
Slit lamp, Autorefractor, IOLMaster 500, Pentacam HR, LenStar LS900, VERION Image Guided System
Intervention: Pentacam HR (Device)
Opthalmologically healthy individuals
Slit lamp, Autorefractor, IOLMaster 500, Pentacam HR, LenStar LS900, VERION Image Guided System
Intervention: LenStar LS900 (Device)
Opthalmologically healthy individuals
Slit lamp, Autorefractor, IOLMaster 500, Pentacam HR, LenStar LS900, VERION Image Guided System
Intervention: VERION Image Guided System (Device)
Outcomes
Primary Outcomes
Accuracy of repeatability of keratometry as performed by VERION Image Guided System
Time Frame: 3 immediate repetitions at study visit (study consists of 1 visit only)
Secondary Outcomes
- Subjective comfort for test persons as evaluated by questionnaire(Immediately after study visit (study consists of 1 visit only))
- Duration of measurements of each keratometric device as taken by stopwatch(During measurements from placement of head until completion)
- Keratometric values as measured by IOLMaster 500, Pentacam HR, LenStar LS900, VERION Image Guided System(At study visit (study consists of 1 visit only))
- White-to-White distance as measured by IOLMaster 500, Pentacam HR, LenStar LS900, VERION Image Guided System(At study visit (study consists of 1 visit only))
- Intraocular lens calculation as performed by IOLMaster 500, LenStar LS900, VERION Image Guided System(Immediately after measurement)
Investigators
Prof. Dr. med. Mike P. Holzer
Ophthalmologist, FEBO
Heidelberg University