Cataract Lens Hardness Based on Phaco Tip Resistance | NCT05110222

Studies
Cataract Lens Hardness Based on Phaco Tip Resistance

NCT05110222

Sponsor

Ospedale Policlinico San Martino

Status

Unknown status

Last Update Posted

Nov 5, 2021Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

Cataract Senile

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2021Actual

Primary Completion Date

Nov 1, 2021Estimated

Completion Date

Dec 20, 2021Estimated

First Submitted Date

Oct 26, 2021

First Submission Date that Met QC Criteria

Oct 26, 2021

First Posted Date

Nov 5, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 26, 2021

Last Update Posted Date

Nov 5, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Phacoemulsificaton tip elongation depends upon voltage once resonant frequency of piezoelectric crystals has been reached.

Purpose of the study is to record voltage data of 20 consecutive cataract surgeries in order to evaluate correlation between voltage and LOCS classification of lens nuclei using a system that deploys a feedback mechanism capable of keeping invariant elongation regardless of enountered resistence

Detailed Description

The R-Evolution (Optikon 2000 Rome, Italy) phaco machine is equipped with a patented system named "minimal stress" that used the direct piezoelectric effect from the resonant ceramics that drive the phacoemulsificator tip to assess in real time and adjust phaco tip elongation that continuously varies according to encountered resistance.

After priming in balanced salt solution, phaco tip elongation and the amount of potential difference (voltage) needed to obtain a ginev elongation in balanced solution is assessed. Once the phaco tip is used during surgery, the resistence offered by the crystalline lens material to the phaco tip reduces actual elongaton which in turn reduces the voltage produced by the directo piezometric effect. The machine uses voltage produced by actual elongation to adjust the diving voltage and therefore can ensure accurate pahco tip elongation under any condition of lens material resistance.

Purpose of the study is to record driving voltage and its variations and evaluate if there is a correlation between phaco tip resistence and drving voltage.

This is evaluated both in vitro activating the phaco tip in increasingly dense glycerol solutions and in real life phaco surgery recording the voltage requested by phaco tip resistence and correlating it to the classification of lens opacity (LOCS III system) clinically used to grade cataract hardness.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
cataract lens hardness according to LOCS III classification system	lens opacity and estimated nucleous hardness according to international LOCS classification	at enrolling
average voltage	voltage necessary to emulsify cataratct nuclous	at the time of surgery
peak voltage	maximum voltage necessary to emulsify cataract nucleous	at the time of surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria: diagnosis of nuclear or cortical cataract

Exclusion Criteria: previous ocular trauma, previous ocular surgery, connective tissue disease

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

we plan to enroll 20 consecutive patients with cataract who did not undergo previous surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tommaso Rossi, MD	Contact	+393482645034		tommaso.rossi024@gmail.com

Overall Officials

Name	Affiliation	Role
Tommaso Rossi, MD	IRCCS Policlinico San MArtino	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IRCCS Policlinico San Martino	Recruiting	Genoa		16100	Italy