Cataract Lens Hardness Based on Phaco Tip Resistance

Cataract Senile Clinical Trial

Official title:

Evaluation of Cataract Lens Hardness Based on Phacoemulsificator Tip Resistance

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05110222
• Other study ID #: 1/2021
• Status: Recruiting
• Start date: September 1, 2021
• Est. completion date: December 20, 2021

Study information

• Verified date: September 2021
• Source: Ospedale Policlinico San Martino
• Contact: Tommaso Rossi, MD
• Phone: +393482645034
• Email: tommaso.rossi024[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 20, 2021
• Est. primary completion date: November 1, 2021
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria: diagnosis of nuclear or cortical cataract

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

Related Conditions & MeSH terms

• Cataract
• Cataract Senile

Locations

Country	Name	City	State
Italy	IRCCS Policlinico San Martino	Genoa

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale Policlinico San Martino

Country where clinical trial is conducted

Italy, 

Outcome

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