Cataract Lens Hardness Based on Phaco Tip Resistance

Sponsor
Ospedale Policlinico San Martino (Other)
Overall Status
Recruiting
CT.gov ID
NCT05110222
Collaborator
(none)
20
1
3.6
5.5

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    20 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Evaluation of Cataract Lens Hardness Based on Phacoemulsificator Tip Resistance
    Actual Study Start Date :
    Sep 1, 2021
    Anticipated Primary Completion Date :
    Nov 1, 2021
    Anticipated Study Completion Date :
    Dec 20, 2021

    Outcome Measures

    Primary Outcome Measures

    1. cataract lens hardness according to LOCS III classification system [at enrolling]

      lens opacity and estimated nucleous hardness according to international LOCS classification

    2. average voltage [at the time of surgery]

      voltage necessary to emulsify cataratct nuclous

    3. peak voltage [at the time of surgery]

      maximum voltage necessary to emulsify cataract nucleous

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All

    Inclusion Criteria: diagnosis of nuclear or cortical cataract

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 IRCCS Policlinico San Martino Genoa Italy 16100

    Sponsors and Collaborators

    • Ospedale Policlinico San Martino

    Investigators

    • Principal Investigator: Tommaso Rossi, MD, IRCCS Policlinico San MArtino

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ospedale Policlinico San Martino
    ClinicalTrials.gov Identifier:
    NCT05110222
    Other Study ID Numbers:
    • 1/2021
    First Posted:
    Nov 5, 2021
    Last Update Posted:
    Nov 5, 2021
    Last Verified:
    Sep 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 5, 2021