NCT05110222

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

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
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2021

Shorter than P25 for all trials

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

Study Start

First participant enrolled

September 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2021

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 5, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2021

Completed
Last Updated

November 5, 2021

Status Verified

September 1, 2021

Enrollment Period

2 months

First QC Date

October 26, 2021

Last Update Submit

October 26, 2021

Conditions

Cataract Senile

Outcome Measures

Primary Outcomes (3)

  • 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

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Policlinico San Martino

Genoa, 16100, Italy

RECRUITING

Study Officials

  • Tommaso Rossi, MD

    IRCCS Policlinico San MArtino

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tommaso Rossi, MD

CONTACT

+393482645034tommaso.rossi024@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2021

First Posted

November 5, 2021

Study Start

September 1, 2021

Primary Completion

November 1, 2021

Study Completion

December 20, 2021

Last Updated

November 5, 2021

Record last verified: 2021-09

Locations

IT(1)