NCT04461912

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 8, 2020

Completed
11 months until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

April 29, 2021

Status Verified

April 1, 2021

Enrollment Period

9 months

First QC Date

June 24, 2020

Last Update Submit

April 28, 2021

Conditions

CataractUltrasound Therapy; Complications

Outcome Measures

Primary Outcomes (1)

  • Presence of Cataract

    Presence of cataract obtained with the Experimental Medical Device (ESUS)

    baseline

Secondary Outcomes (3)

  • Cataract classification

    baseline

  • Cataract hardness

    before the intervention/procedure/surgery

  • Phacoemulsification energy

    immediately after the intervention/procedure/surgery

Study Arms (2)

Cataract

EXPERIMENTAL

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

Device: Eye Scan Ultrasound System (ESUS)

Control

PLACEBO COMPARATOR

Participants on which the presence of cataract have been excluded

Device: Eye Scan Ultrasound System (ESUS)

Interventions

Eye Scan Ultrasound System (ESUS)DEVICE

• 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.

CataractControl

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cataract group:
  • Patients with age-related cataract;
  • Indication of phacoemulsification surgery
  • Control group:
  • Patients without cataract

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Cirúrgico de Coimbra (CCCI)

Coimbra, Portugal

Location

Related Publications (1)

  • Petrella L, Nunes S, Perdigao F, Gomes M, Santos M, Pinto C, Morgado M, Travassos A, Santos J, Caixinha M. Feasibility assessment of the Eye Scan Ultrasound System for cataract characterization and optimal phacoemulsification energy estimation: protocol for a pilot, nonblinded and monocentre study. Pilot Feasibility Stud. 2022 Sep 29;8(1):219. doi: 10.1186/s40814-022-01173-2.

    PMID: 36175978DERIVED

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Miguel Caixinha, PhD

    miguel.caixinha@gmail.com

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jaime Santos, PhD

CONTACT

+351 239 796 200jaime@deec.uc.pt

Miguel Caixinha, PhD

CONTACT

miguel.caixinha@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: The study includes participants with age-related cataract and healthy subjects as control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator Responsible

Study Record Dates

First Submitted

June 24, 2020

First Posted

July 8, 2020

Study Start

June 1, 2021

Primary Completion

March 1, 2022

Study Completion

September 1, 2022

Last Updated

April 29, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

PT(1)