NCT04082273

Comparison of Femto-laser and Manually Created Clear Corneal Incisions During Cataract Surgery

A Single Center, Randomized Control Study to Compare Efficacy and Safety of Femto-laser Created Clear Corneal Incisions with Manually Created Clear Corneal Incisions During Cataract Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Ziemer Ophthalmic Systems AG · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to test the hypothesis, that in terms of Surgically Induced corneal Astigmatism (SIA), Higher-order Aberrations (HOA), and wound geometry the femtosecond clear corneal incisions (CCIs) created during cataract surgery are not inferior when compared to manual CCIs. The potential risks associated with application of the femtosecond laser in this study are no greater or in most cases less than those associated with the standard manual cataract surgical procedure, and the potential benefits (such as precision and reproducibility) are greater than with the standard manual cataract surgery. Therefore, the risk-to-benefit ratio is very low, such that the potential benefits for a subject participating in this study exceed the potential risks

Conditions

• Cataract

Interventions

Type	Name	Description
DEVICE	Femtosecond Laser for Cataract Surgery	Cataract Surgery on study eye according to conventional procedure, with the exception of three steps (Capsulotomy, Lens Fragmentation and Clear Corneal Incisions) which are performed with a Femtosecond Laser in the laser treatment group. Equipment uesd for measurements is the same for both groups and in line with the normal equipment used for the conventional cataract treatment
OTHER	Conventional Cataract Surgery	Cataract surgery will be performed conventionally, this means the clear corneal incisions will be performed manually by a blade, the capsulorhexis will be performed manually by a hook, and the lens extraction will be done by phacoemulsification

Timeline

• Start date: 2019-08-26
• Primary completion: 2024-07-15
• Completion: 2024-07-15
• First posted: 2019-09-09
• Last updated: 2024-11-04

Locations

1 site across 1 country: Switzerland