Comparison of Two Fragmentation Modalities in Femtosecond Laser-assisted Cataract Surgery

Cataract Clinical Trial

— SLICES  

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02898909
• Other study ID #: JFO_2015_44
• Status: Terminated
• Phase: N/A
• Start date: November 15, 2016
• Est. completion date: December 10, 2019

Study information

• Verified date: December 2019
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Femtosecond laser-assisted cataract surgery consists in nuclear lens fragmentation, followed by ultrasound phacoemulsification of nuclear lens, which is then removed.

It can be assumed that fragmenting the nuclear lens in more pieces could facilitate the post-laser ultrasound phacoemulsification to extract the lens, with a lesser amount of ultrasonic energy.

The decrease of ultrasonic energy delivered during cataract surgery is beneficial to the patient because it optimizes the vitality of corneal endothelial cells, which ensure corneal transparency.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: December 10, 2019
• Est. primary completion date: December 21, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patient aged = 18 years old

• first Femtosecond Laser-assisted Cataract Surgery scheduled

• cataract density = 3 according to the lens opacities classification system (LOCS)

Exclusion Criteria:

• corneal guttata, uncontrolled glaucoma

• shallow depth of anterior chamber

• patient's refusal to participate in the study

• pregnant or breast feeding patient

• patient under legal protection

• no health coverage

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• nuclear lens fragmentation in 8 pieces

• nuclear lens fragmentation in 16 pieces

Locations

Country	Name	City	State
France	Fondation Opthalmologique A de Rothschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	energy delivered for lens nucleus aspiration during phacoemulsification	ultrasound power delivered (measured in Hertz)	approximatively 15 minutes