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Cataract Lens Hardness Based on Phaco Tip Resistance

Evaluation of Cataract Lens Hardness Based on Phacoemulsificator Tip Resistance

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05110222
Enrollment
20
Registered
2021-11-05
Start date
2021-09-01
Completion date
2021-12-20
Last updated
2021-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract Senile

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.

Interventions

None listed

Sponsors

Ospedale Policlinico San Martino
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years

Inclusion criteria

diagnosis of nuclear or cortical cataract

Exclusion criteria

previous ocular trauma, previous ocular surgery, connective tissue disease

Design outcomes

Primary

MeasureTime frameDescription
peak voltageat the time of surgerymaximum voltage necessary to emulsify cataract nucleous
cataract lens hardness according to LOCS III classification systemat enrollinglens opacity and estimated nucleous hardness according to international LOCS classification
average voltageat the time of surgeryvoltage necessary to emulsify cataratct nuclous

Countries

Italy

Contacts

Primary ContactTommaso Rossi, MD
tommaso.rossi024@gmail.com+393482645034

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026