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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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


Condition or disease Intervention/treatment Phase
Cataract Device: Femtosecond Laser for Cataract Surgery Other: Conventional Cataract Surgery Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 26, 2019
Estimated Primary Completion Date : July 30, 2020
Estimated Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Central corneal thickness (CCT) [ Time Frame: Baseline = Pre-operative, Follow-up = 1 day, 12 days, 4 weeks and 6 weeks after surgery ]
  3. Endothelial cell density (ECD) [ Time Frame: Baseline = Pre-operative, Follow-up = 1 day, 12 days, 4 weeks and 6 weeks after surgery ]
  4. Effective Phacoemulsification Time (EPT) [ Time Frame: Baseline = Treatment day ]
  5. Ultrasound total time (US) [ Time Frame: Baseline = Treatment day ]
  6. 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

  7. 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 ]
  8. FEMTO LDV Z8 OCT auto - detection accuracy [ Time Frame: Baseline = Treatment day ]
    Analyzed on intra-operative Z8 OCT images



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04082273


Contacts
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Contact: Bojan Pajic, MD, PhD +41 62 765 60 80 bojan.pajic@orasis.ch

Locations
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Switzerland
Augenklinik ORASIS AG Recruiting
Reinach AG, Aargau, Switzerland, 5734
Contact: Bojan Pajic, MD, PhD    +41 62 765 60 80    bojan.pajic@orasis.ch   
Sponsors and Collaborators
Ziemer Ophthalmic Systems AG
Investigators
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Principal Investigator: Bojan Pajic, MD, PhD Augenklinik ORASIS AG
Publications:

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Responsible Party: Ziemer Ophthalmic Systems AG
ClinicalTrials.gov Identifier: NCT04082273    
Other Study ID Numbers: CPFEM-0005-CH
First Posted: September 9, 2019    Key Record Dates
Last Update Posted: June 30, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ziemer Ophthalmic Systems AG:
Induced corneal Astigmatism
Clear corneal incisions
Femto-laser
Additional relevant MeSH terms:
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Cataract
Surgical Wound
Lens Diseases
Eye Diseases
Wounds and Injuries