Repeatability in Measurements of Two ssOCT and One OLCR Biometer

NCT ID: NCT04255706

Last Updated: 2020-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-25

Study Completion Date

2020-04-01

Brief Summary

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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

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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.

Conditions

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Cataract Senile

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Biometric measurement repeatability

Biometric measurements will be performed in all patients

Group Type OTHER

biometric measurement IOLMaster 700

Intervention Type DEVICE

Three biometric measurements will be performed with 3 devices for all the patients included

biometric measurement Lenstar LS 700

Intervention Type DEVICE

Three biometric measurements will be performed with 3 devices for all the patients included

biometric measurement Anterion Heildelberg

Intervention Type DEVICE

Three biometric measurements will be performed with 3 devices for all the patients included

Interventions

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biometric measurement IOLMaster 700

Three biometric measurements will be performed with 3 devices for all the patients included

Intervention Type DEVICE

biometric measurement Lenstar LS 700

Three biometric measurements will be performed with 3 devices for all the patients included

Intervention Type DEVICE

biometric measurement Anterion Heildelberg

Three biometric measurements will be performed with 3 devices for all the patients included

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prim. Prof. Dr. Oliver Findl, MBA

OTHER

Sponsor Role lead

Responsible Party

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Prim. Prof. Dr. Oliver Findl, MBA

Head of the Ophthalmology Department, and Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Oliver Findl, Prof

Role: PRINCIPAL_INVESTIGATOR

VIROS, Hanusch Hospital Vienna

Locations

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Vienna Institute for Research in Ocular Surgery (VIROS)

Vienna, , Austria

Site Status

Countries

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Austria

References

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Fisus AD, Hirnschall ND, Ruiss M, Pilwachs C, Georgiev S, Findl O. Repeatability of 2 swept-source OCT biometers and 1 optical low-coherence reflectometry biometer. J Cataract Refract Surg. 2021 Oct 1;47(10):1302-1307. doi: 10.1097/j.jcrs.0000000000000633.

Reference Type DERIVED
PMID: 33770018 (View on PubMed)

Other Identifiers

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ANT

Identifier Type: -

Identifier Source: org_study_id

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