CataractCATARCTUSNCT04461912
Ultrasonic System for Cataract Characterization and Optimal Phacoemulsification Energy Evaluation
A study testing Eye Scan Ultrasound System (ESUS) in people with Cataract and Ultrasound Therapy; Complications, run by University of Coimbra at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cataract, Ultrasound Therapy; Complications
- What is being tested?
- Eye Scan Ultrasound System (ESUS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Jun 2021to 1 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Cataract group:
- Patients with age-related cataract;
- Indication of phacoemulsification surgery
- Control group:
- Patients without cataract
Who cannot join
- Presence of any other ophthalmological condition or systemic disease that could affect the results
Trial locations and contacts
1 site in 1 country.
Miguel Caixinha, PhD contact
Portugal1 site
Centro Cirúrgico de Coimbra (CCCI)
Coimbra
António Travassos, MD
António Travassos, MD
About this study
Official title: Development of a Medical Device Based on Ultrasounds for Objective Cataract Characterization and Optimal Phacoemulsification Energy Evaluation
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.
Read the 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.
- Conditions
- Cataract, Ultrasound Therapy; Complications
- Being tested
- Eye Scan Ultrasound System (ESUS)
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Cataract | Experimental | Participants with diverse types and severities of cataract, that should realize phacoemulsification surgery Receives: Device: Eye Scan Ultrasound System (ESUS) |
| Control | Placebo comparator | Participants on which the presence of cataract have been excluded Receives: Device: Eye Scan Ultrasound System (ESUS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of Cataract
Presence of cataract obtained with the Experimental Medical Device (ESUS)
Measured: baseline
Secondary outcomes (3)
Cataract classification
Cataract type and severity obtained with the Experimental Medical Device (ESUS) - based on the LOCS III (Lens Opacity Classification System)
Measured: baseline
Cataract hardness
Cataract hardness estimated with the Experimental Medical Device (in Gpa)
Measured: before the intervention/procedure/surgery
Phacoemulsification energy
Phacoemulsification energy level estimated with the Experimental Medical Device in the participants performing cataract surgery (considering the phacoemulsification energy parameters provided by the phacoemulsifier).
Measured: immediately after the intervention/procedure/surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start1 Jun 2021 (estimated)
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study includes participants with age-related cataract and healthy subjects as control group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Coimbra
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação para a Ciência e a Tecnologia
- Responsible party
- Principal investigator, Jaime Batista Santos, University of Coimbra
- Investigators
- Miguel Caixinha, PhD, Principal investigator, miguel.caixinha@gmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04461912
- Sponsor's protocol ID
- POCI-01-0145-FEDER-028758
- Acronym
- CATARCTUS
- Status last verified
- Apr 2021
- First submitted
- 24 Jun 2020
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36175978
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Medical Device Based on Ultrasounds for Objective Cataract Characterization and Optimal Phacoemulsification Energy Evaluation
- ClinicalTrials.gov ID
- NCT04461912
- Acronym / sponsor ID
- CATARCTUS / POCI-01-0145-FEDER-028758
- Conditions
- Cataract, Ultrasound Therapy; Complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of CoimbraUniversity, hospital or other
- Collaborators
- Fundação para a Ciência e a Tecnologia
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 8 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study includes participants with age-related cataract and healthy subjects as control group
| Arm | Type | Receives |
|---|---|---|
| Cataract | Experimental | Device: Eye Scan Ultrasound System (ESUS)Participants with diverse types and severities of cataract, that should realize phacoemulsification surgery |
| Control | Placebo comparator | Device: Eye Scan Ultrasound System (ESUS)Participants on which the presence of cataract have been excluded |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with age-related cataract;
- Indication of phacoemulsification surgery
- Patients without cataract
Key exclusion criteria (1 listed)
- Presence of any other ophthalmological condition or systemic disease that could affect the results
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Cataract, Control |
Primary outcome
Presence of Cataract
Time frame: baseline
Presence of cataract obtained with the Experimental Medical Device (ESUS)
3 secondary outcomes
Cataract classification
Time frame: baseline
Cataract hardness
Time frame: before the intervention/procedure/surgery
Phacoemulsification energy
Time frame: immediately after the intervention/procedure/surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
- Derived from this study: PubMed 36175978Petrella 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miguel Caixinha, PhD contact
Miguel Caixinha, PhD principal investigator
miguel.caixinha@gmail.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eye Scan Ultrasound System (ESUS) in people with Cataract and Ultrasound Therapy; Complications, run by University of Coimbra at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jaime Santos, PhD (+351 239 796 200, jaime@deec.uc.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of Cataract (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04461912, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2021.