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

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ClinicalTrials.gov Identifier: NCT04082273
Recruitment Status : Recruiting
First Posted : September 9, 2019
Last Update Posted : June 30, 2020
Sponsor:
Information provided by (Responsible Party):
Ziemer Ophthalmic Systems AG

Tracking Information
First Submitted Date  ICMJE September 2, 2019
First Posted Date  ICMJE September 9, 2019
Last Update Posted Date June 30, 2020
Actual Study Start Date  ICMJE August 26, 2019
Estimated Primary Completion Date July 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2019)
Change from baseline (pre-operative) Surgically Induced corneal Astigmatism (SIA) measured by visual acuity (LogMAR) [ Time Frame: Baseline = Pre-operative, Follow-up = 12 days, 4 weeks and 6 weeks after surgery ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2019)
  • Change from baseline (pre-operative) Higher-order aberrations (HOAs) measured by the Shack-Hartmann aberrometry method [ Time Frame: Baseline = Pre-operative, Follow-up = 12 days, 4 weeks and 6 weeks after surgery ]
  • Central corneal thickness (CCT) [ Time Frame: 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 ]
  • Effective Phacoemulsification Time (EPT) [ Time Frame: Baseline = Treatment day ]
  • Ultrasound total time (US) [ Time Frame: Baseline = Treatment day ]
  • Achieved CCI architecture [ Time Frame: Baseline = Treatment day ]
    Presence of Descemet membrane detachment, posterior and anterior wound gape, if present size) will be analyzed on OCT images
  • 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 ]
  • FEMTO LDV Z8 OCT auto - detection accuracy [ Time Frame: Baseline = Treatment day ]
    Analyzed on intra-operative Z8 OCT images
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Femto-laser and Manually Created Clear Corneal Incisions During Cataract Surgery
Official Title  ICMJE 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
Brief 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

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Cataract
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Femtosecond Laser for Cataract Surgery
    Capsulotomy, lens fragmentation and Clear Corneal Incisions with FEMTO LDV Z8, followed by ultrasound phacoemulsification and IOL implantation.
    Intervention: Device: Femtosecond Laser for Cataract Surgery
  • 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.
    Intervention: Other: Conventional Cataract Surgery
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 5, 2019)
94
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 1, 2020
Estimated Primary Completion Date July 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Cataract surgery planned
  • Accurate baseline biometric measurements and assessed medical status
  • Subject able to cooperate with the docking system of the laser
  • Full pupil dilatation

Exclusion Criteria:

  • Glaucoma
  • Pseudoexfoliation
  • Small pupils
  • Previous corneal surgery
  • Other ophthalmological diseases
  • Corneal scars
  • Pterygium
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Bojan Pajic, MD, PhD +41 62 765 60 80 bojan.pajic@orasis.ch
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04082273
Other Study ID Numbers  ICMJE CPFEM-0005-CH
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ziemer Ophthalmic Systems AG
Study Sponsor  ICMJE Ziemer Ophthalmic Systems AG
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Bojan Pajic, MD, PhD Augenklinik ORASIS AG
PRS Account Ziemer Ophthalmic Systems AG
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP