Eye Scan Ultrasound System for Automatic Cataract Detection: From a Preclinical to a Clinical Prototype

Petrella, Lorena; Gomes, Marco; Perdigão, Fernando; Santos, Mário; Fernandes, Paulo; Pinto, Carlos Eduardo Pinto de; Nunes, Sandrina; Morgado, Miguel; Caixinha, Miguel; Santos, Jaime

doi:10.1007/978-3-030-31635-8_97

Cited by 3 publications

(3 citation statements)

References 13 publications

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“…The present pilot study protocol aims to evaluate the Eye Scan Ultrasound System (ESUS), which was developed in the preclinical studies [22] and adapted for clinical applications [23] in human lenses in vivo. Because it is a first in human study, and to reduce risks and optimize human and financial resources, a pilot protocol was designed for feasibility assessment of the ESUS in clinical practice.…”

Section: Introductionmentioning

confidence: 99%

Feasibility assessment of the Eye Scan Ultrasound System for cataract characterization and optimal phacoemulsification energy estimation: protocol for a pilot, nonblinded and monocentre study

Petrella

Nunes

Perdigão

et al. 2022

Pilot Feasibility Stud

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Background Cataracts are lens opacifications that are responsible for more than half of blindness cases worldwide, and the only treatment is surgical intervention. Phacoemulsification surgery, the most frequently performed cataract surgery in developed countries, has associated risks, some of which are related to excessive phacoemulsification energy levels and times. The protocol proposed in herein will be used to evaluate the feasibility of a new experimental medical device, the Eye Scan Ultrasound System (ESUS), for the automatic classification of cataract type and severity and quantitative estimation of the optimal phacoemulsification energy. Methods The pilot study protocol will be used to evaluate the feasibility and safety of the ESUS in clinical practice. The study will be conducted in subjects with age-related cataracts and on healthy subjects as controls. The procedures include data acquisition with the experimental ESUS, classification based on the Lens Opacity Classification System III (LOCS III, comparator) using a slit lamp, contrast sensitivity test, optical coherence tomography, specular microscopy and surgical parameters. ESUS works in A-scan pulse-echo mode, with a central frequency of 20 MHz. From the collected signals, acoustic parameters will be extracted and used for automatic cataract characterization and optimal phacoemulsification energy estimation. The study includes two phases. The data collected in the first phase (40 patients, 2 eyes per patient) will be used to train the ESUS algorithms, while the data collected in the second phase (10 patients, 2 eyes per patient) will be used to assess the classification performance. System safety will be monitored during the study. Discussion The present pilot study protocol will evaluate the feasibility and safety of the ESUS for use in clinical practice, and the results will support a larger clinical study for the efficacy assessment of the ESUS as a diagnostic tool. Ultimately, the ESUS is expected to represent a valuable tool for surgical planning by reducing complications associated with excessive levels of phacoemulsification energy and surgical times, which will have a positive impact on healthcare systems and society. The study is not yet recruiting. Trial registration ClinicalTrials.gov identifier NCT04461912, registered on July 8, 2020.

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Section: Introductionmentioning

confidence: 99%

Feasibility assessment of the Eye Scan Ultrasound System for cataract characterization and optimal phacoemulsification energy estimation: protocol for a pilot, nonblinded and monocentre study

Petrella

Nunes

Perdigão

et al. 2022

Pilot Feasibility Stud

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“…In this sense, the prototype was adapted for clinical applications. 17 Before proceeding to a clinical trial, a safety assessment is a mandatory task. In this study, the procedures involved in risk identification and management are described, with an emphasis on the calibration of the ultrasonic field.…”

mentioning

confidence: 99%

“…The detection and classification of a cataract according its type and severity, as well as estimation of the optimal phacoemulsification energy to be used in cataract surgery is expected. In this sense, the prototype was adapted for clinical applications . Before proceeding to a clinical trial, a safety assessment is a mandatory task.…”

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confidence: 99%

Safety Assessment of an A‐Scan Ultrasonic System for Ophthalmic Use

Petrella

Fernandes

Santos

et al. 2020

J of Ultrasound Medicine

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Objectives-This study describes the safety assessment of an A-scan ultrasonic system for ophthalmic use. The system is an investigational medical device for automatic cataract detection and classification. Methods-The risk management was based on the International Organization for Standardization (ISO) standard DIN EN ISO 14971:2009-10 and International Electrotechnical Commission (IEC) standard IEC 60601-2-37. The calibration of the ultrasonic field was conducted according to the standards IEC 62127-1:2007 and IEC 62359:2010. The uncertainty on measurements was delineated in agreement with the guide JCGM 100:2008. Results-After risk management, all risks were qualitatively classified as acceptable. The mechanical index (0.08 AE 0.05), soft tissue thermal index (0.08 AE 0.08) and spatial-peak temporal-average intensity (0.56 AE 0.59 mW/cm 2) were under the maximum index values indicated by the US Food and Drug Administration guidance, Marketing Clearance of Diagnostic Ultrasound Systems and Transducers (0.23, 1, and 17 mW/cm 2 , respectively). Conclusions-This study presents a practical approach for the safety assessment of A-scan ultrasonic systems for ophthalmic use. The safety evaluation of a medical device is mandatory before its use in clinical practice. However, the safety monitoring throughout its life cycle should also be considered, since many device components may deteriorate over time and use.

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