Ultrasonic System for Cataract Characterization and Optimal Phacoemulsification Energy Evaluation (CATARCTUS)

University of Coimbra

Status: Unknown

Conditions: Cataract; Ultrasound Therapy; Complications

Treatments: Device: Eye Scan Ultrasound System (ESUS)

Study type: Interventional

Funder types: Other

Identifiers

NCT04461912

POCI-01-0145-FEDER-028758

Details and patient eligibility

About

This study aims to assess the performance of an ultrasonic system for automatic classification of cataract type and severity, as well as the estimation of the optimal phacoemulsification energy. Ultrasonic signals from the lens will be acquired with the Experimental Medical Device (ESUS) in participants with cataract, and in healthy subjects (control).

The proposed technique may represent an important advance in cataract treatment. The quantitative and automatic classification of cataract type and severity, and the estimation of the optimal phacoemulsification energy is may represent a valuable tool for surgical planning, reducing complications associated to excessive levels of phacoemulsification energy, as well as the times spent on surgeries. This device may be relevant not only for patients, but also for public health systems, reducing waiting lists and associated costs.

Full description

This is a prospective, pivotal, non-blinded study. Fifty (50) participants will be recruited at the Coimbra Surgical Center of Portugal. The study will be conducted on subjects with age-related cataract, and on healthy subjects as control group. Since this is a pilot study, no sample size estimation has been implemented. The statistical power will be determined at the end of the study. Only per-protocol participants will be considered on statistical analysis.

Procedures involved. The ultrasonic system (Experimental Medical Device - ESUS) works in A-scan mode, with an acoustic working frequency of 20 MHz. From the ultrasonic signals backscattered from the lenses, acoustic parameters will be extracted, and used for automatic algorithms implementation. This study will be implemented once.

Slit lamp with LOCS III classification will be used as comparator. Contrast sensitivity test results will be used for incipient cataract detection, where slit lamp may present some limitations. Optical coherence tomography and specular microscopy will help on detecting postoperative complications; other complications identified by the physician will be also considered. Surgical parameters as phacoemulsification energy and surgical time will help on phacoemulsification energy evaluation.

Safety assessment. The system uses an ophthalmic probe. There are not anticipated adverse events related to the procedures involved in the use of the ultrasonic system, or any other procedure in the protocol. The safety conditions will be monitored through the occurrence of unanticipated adverse events or serious adverse events. If these situations occur, the event will be reported to the competent authorities (in agreement with the current regulation) and the corrective actions will be implemented.

Enrollment: 50 estimated patients

Sex: All

Ages: 50 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Cataract group:

• Patients with age-related cataract;
• Indication of phacoemulsification surgery

Control group:

• Patients without cataract

Exclusion criteria

• Presence of any other ophthalmological condition or systemic disease that could affect the results

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups, including a placebo group

Cataract

Experimental group

Description:

Participants with diverse types and severities of cataract, that should realize phacoemulsification surgery

Treatment:

Device: Eye Scan Ultrasound System (ESUS)

Control

Placebo Comparator group

Description:

Participants on which the presence of cataract have been excluded

Treatment:

Device: Eye Scan Ultrasound System (ESUS)