MedTrace Logo

Ultrasonic System for Cataract Characterization and Optimal Phacoemulsification Energy Evaluation

NCT04461912 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2021-04-29

No results posted yet for this study

Summary

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.

Conditions

  • Cataract
  • Ultrasound Therapy; Complications

Interventions

DEVICE

Eye Scan Ultrasound System (ESUS)

• For the ultrasonic signals acquisitions, an ophthalmic probe working in A-mode scan, must be coupled to the cornea. To reduce the discomfort generated by coupling the probe, topical anaesthesia (oxybuprocaine hydrochloride) will be applied before starting acquisitions. However, if the participant has some known contraindication to this anaesthetic, in replacement, a disposable neutral contact lens will be used as coupling medium between the probe and the cornea. The acquisitions are initiated through a starting button in the system's user interface, and the probe must be kept by few seconds for automatic signals records. During this period, signals are visualized in the user interface. Finally the probe is uncoupled, and the acquired signals are saved.

Sponsors & Collaborators

  • Fundação para a Ciência e a Tecnologia

    collaborator OTHER

  • University of Coimbra

    lead OTHER

Principal Investigators

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2022-03-01
Completion
2022-09-01

Countries

  • Portugal

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04461912 on ClinicalTrials.gov