MedTrace Logo

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

NCT04082273 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-11-04

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Ziemer Ophthalmic Systems AG

    lead INDUSTRY

Principal Investigators

  • Bojan Pajic, MD, PhD · Augenklinik ORASIS AG

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-26
Primary Completion
2024-07-15
Completion
2024-07-15

Countries

  • Switzerland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04082273 on ClinicalTrials.gov