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Clinical Trials/NCT04255706
NCT04255706
Completed
Not Applicable

Evaluation of Repeatability in Measurements of Two Swept-source Optical Coherence Tomography (Ss-OCT) Biometers and One Optical Low Coherence Reflectometry (OLCR) Biometer

Prim. Prof. Dr. Oliver Findl, MBA1 site in 1 country50 target enrollmentNovember 25, 2019
ConditionsCataract Senile

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cataract Senile
Sponsor
Prim. Prof. Dr. Oliver Findl, MBA
Enrollment
50
Locations
1
Primary Endpoint
Evaluation of repeatability between two ss-OCT and one OLCR biometry device
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

Achieving high accuracy and precision in ocular biometry has become primordial for cataract surgery, due to the shift of cataract surgery from a rehabilitation procedure to a refractive one.

Aim of this study is to determine the repeatability of ocular biometric parameters obtained using three biometry devices, two ss-OCT biometers and an OLCR device.

Detailed Description

Accurate and repeatable biometric measurements are essential in providing an optimal refractive outcome. ss-OCT biometry uses a tunable wavelength laser source to scan the eye, this technology showing its superiority through better signal-to-noise ratio, the wavelength light source being projected into the eye, one at a time; thus improving tissue penetration. This a prospective observational study that would include patients which attended pre-surgical examination. A written informed consent will be obtained from each patient. Only one eye from each patient will be included in the study. All patients included in the study will undergo biometric measurements in a random fashion with the three devices (IOLMaster 700, Lenstar LS 700 and Anterion Heildelberg). Each patient will be measured three times with each device and between the measurements they will be asked to blink or keep their eyes closed for tear film recovery and to avoid fatigue. Scans that pass the quality requirement of each device will be taken for analysis.

Registry
clinicaltrials.gov
Start Date
November 25, 2019
End Date
April 1, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Prim. Prof. Dr. Oliver Findl, MBA
Responsible Party
Sponsor Investigator
Principal Investigator

Prim. Prof. Dr. Oliver Findl, MBA

Head of the Ophthalmology Department, and Principal Investigator

Vienna Institute for Research in Ocular Surgery

Eligibility Criteria

Inclusion Criteria

  • 40 years old or above
  • age-related cataract

Exclusion Criteria

  • patients with dense cataract or corneal pathology that would significantly influence biometric measurements
  • nystagmus or pathologies that would affect patient fixation
  • pregnancy- for women in reproductive age a pregnancy test will be performed.

Outcomes

Primary Outcomes

Evaluation of repeatability between two ss-OCT and one OLCR biometry device

Time Frame: 8 months

Repeatability coefficient (within subject standard deviation - SD) and coefficient of variation between two ss-OCT and the OLCR biometry device will be calculated for all the parameters (axial length, keratometry, anterior chamber depth, lens thickness)

Study Sites (1)

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