Comparison of Femto-laser and Manually Created Clear Corneal Incisions During Cataract Surgery (Z8_CCI)

October 31, 2024 updated by: Ziemer Ophthalmic Systems AG

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Aargau
      • Reinach AG, Aargau, Switzerland, 5734
        • Augenklinik ORASIS AG

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Eligible to undergo cataract extraction by phacoemulsification with primary intraocular lens implantation
  • Able to co-operate with the docking system for the femtosecond laser
  • Clear corneal media
  • 40 years of age or older
  • Willing and able to return for scheduled follow-up examinations

Exclusion Criteria:

  • Minimal and maximal K-values of the central 3mm zone that differ by more than 5D on a keratometric map of the cornea
  • Maximum K-value that exceeds 58.D
  • Minimal K-value of less than 37.D
  • Corneal disease or pathology, such as corneal scaring or opacity, that precludes transmission of laser wavelength or that distorts laser light
  • Poorly dilating pupil or other defect of the pupil that prevents the iris from adequate retraction peripherally
  • Manifest Glaucoma+OHT (ocular hypertension), pseudoexfoliation
  • Previous intraocular or corneal surgery of any kind, including any type of surgery for either refractive or therapeutic purposes in either eye
  • Known sensitivity to planned concomitant medications
  • History of lens or zonular instability
  • Keratoconus or keratectasia
  • Immune compromised or diagnosis of connective tissue disease, clinically significant atopic disease, insulin dependent diabetes mellitus, autoimmune diseases, ocular herpes zoster or simplex, endocrine diseases, lupus, RA, collagenosis and other acute or chronic illnesses that increases the risk to the subject or confounds the outcomes of this study, in the opinion of the study Pl.
  • Anterior chamber depth (ACD) < 1.5 mm or ACD > 4.8 mm as measured from the corneal endothelium.
  • Extensive corneal scarring, pterygium
  • Developmental disability or cognitive impairment (would preclude adequate comprehension of the IC form and/or the ability to record the study measurements)
  • Concurrent participation in another ophthalmological clinical study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Femtosecond Laser for Cataract Surgery
Capsulotomy, lens fragmentation and Clear Corneal Incisions with FEMTO LDV Z8, followed by ultrasound phacoemulsification and IOL implantation.
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
Active Comparator: Conventional Cataract Surgery
Clear Corneal Incisions, conventional capsulorhexis and ultrasound phacoemulsification and IOL implantation. Control treatment where the clear corneal incisions and capsulorhexis are performed manually and the lens fragmentation is performed with the phacoemulsification device.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline (pre-operative) Surgically Induced corneal Astigmatism (SIA) measured by means of corneal topography Galilei G2
Time Frame: Baseline = Pre-operative, Follow-up = 12 days, 4 weeks and 6 weeks after surgery
Baseline = Pre-operative, Follow-up = 12 days, 4 weeks and 6 weeks after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Central corneal thickness (CCT)
Time Frame: Baseline = Pre-operative, Follow-up = 1 day, 12 days, 4 weeks and 6 weeks after surgery
Baseline = Pre-operative, Follow-up = 1 day, 12 days, 4 weeks and 6 weeks after surgery
Endothelial cell density (ECD)
Time Frame: Baseline = Pre-operative, Follow-up = 1 day, 12 days, 4 weeks and 6 weeks after surgery
Baseline = Pre-operative, Follow-up = 1 day, 12 days, 4 weeks and 6 weeks after surgery
Effective Phacoemulsification Time (EPT)
Time Frame: Baseline = Treatment day
Baseline = Treatment day
Ultrasound total time (US)
Time Frame: Baseline = Treatment day
Baseline = Treatment day
Intra- and post-operative CCI related complications rate
Time Frame: Baseline = Treatment day, Follow-up = 1 day, 12 days, 4 weeks and 6 weeks after surgery
Baseline = Treatment day, Follow-up = 1 day, 12 days, 4 weeks and 6 weeks after surgery
FEMTO LDV Z8 OCT auto - detection accuracy
Time Frame: Baseline = Treatment day
Analyzed on intra-operative Z8 OCT images
Baseline = Treatment day
Change from baseline (pre-operative) Higher-order aberrations (HOAs) by means of aberrometry using Galilei G2
Time Frame: Baseline = Pre-operative, Follow-up = 12 days, 4 weeks and 6 weeks after surgery
Baseline = Pre-operative, Follow-up = 12 days, 4 weeks and 6 weeks after surgery
Achieved CCI architecture
Time Frame: 1 day postoperative and 12 days postoperative
Presence of Descemet membrane detachment, posterior and anterior wound gape, if present size) will be analyzed on OCT images
1 day postoperative and 12 days postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ziemer Ophthalmic Systems AG

Investigators

  • Principal Investigator: Bojan Pajic, MD, PhD, Augenklinik ORASIS AG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 26, 2019

Primary Completion (Actual)

July 15, 2024

Study Completion (Actual)

July 15, 2024

Study Registration Dates

First Submitted

September 2, 2019

First Submitted That Met QC Criteria

September 5, 2019

First Posted (Actual)

September 9, 2019

Study Record Updates

Last Update Posted (Estimated)

November 4, 2024

Last Update Submitted That Met QC Criteria

October 31, 2024

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPFEM-0005-CH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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