Clinical trial NCT04461912: Ultrasonic System for Cataract Characterization and Optimal Phacoemulsification Energy Evaluation
Official title: Development of a Medical Device Based on Ultrasounds for Objective Cataract Characterization and Optimal Phacoemulsification Energy Evaluation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cataract
Ultrasound Therapy; Complications
Lead sponsor: University of Coimbra
Sponsor class: OTHER
Collaborators: name: Fundação para a Ciência e a Tecnologia
First posted: 2020-07-08
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study includes participants with age-related cataract and healthy subjects as control group
Primary purpose: DIAGNOSTIC

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Presence of Cataract
timeFrame: baseline
Secondary outcomes:
measure: Cataract classification
timeFrame: baseline
measure: Cataract hardness
timeFrame: before the intervention/procedure/surgery
measure: Phacoemulsification energy
timeFrame: immediately after the intervention/procedure/surgery
Other outcomes:
Locations:
city: Coimbra
country: Portugal
facility: Centro Cirúrgico de Coimbra (CCCI)
Study officials:
affiliation: miguel.caixinha@gmail.com
name: Miguel Caixinha, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.