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

Sponsor
Ziemer Ophthalmic Systems AG (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04082273
Collaborator
(none)
94
Enrollment
1
Location
2
Arms
28.2
Anticipated Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: Femtosecond Laser for Cataract Surgery
  • Other: Conventional Cataract Surgery
 N/A

Study Design

Study Type:
Interventional
Anticipated 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 :
Aug 26, 2019
Anticipated Primary Completion Date :
Nov 30, 2021
Anticipated Study Completion Date :
Dec 30, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change from baseline (pre-operative) Surgically Induced corneal Astigmatism (SIA) measured by visual acuity (LogMAR) [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 [Baseline = Pre-operative, Follow-up = 12 days, 4 weeks and 6 weeks after surgery]

  2. Central corneal thickness (CCT) [Baseline = Pre-operative, Follow-up = 1 day, 12 days, 4 weeks and 6 weeks after surgery]

  3. Endothelial cell density (ECD) [Baseline = Pre-operative, Follow-up = 1 day, 12 days, 4 weeks and 6 weeks after surgery]

  4. Effective Phacoemulsification Time (EPT) [Baseline = Treatment day]

  5. Ultrasound total time (US) [Baseline = Treatment day]

  6. Achieved CCI architecture [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 [Baseline = Treatment day, Follow-up = 1 day, 12 days, 4 weeks and 6 weeks after surgery]

  8. FEMTO LDV Z8 OCT auto - detection accuracy [Baseline = Treatment day]

    Analyzed on intra-operative Z8 OCT images

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Augenklinik ORASIS AG Reinach AG Aargau Switzerland 5734

Sponsors and Collaborators

  • Ziemer Ophthalmic Systems AG

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ziemer Ophthalmic Systems AG
ClinicalTrials.gov Identifier:
NCT04082273
Other Study ID Numbers:
  • CPFEM-0005-CH
First Posted:
Sep 9, 2019
Last Update Posted:
Jul 14, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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:
Cataract
Surgical Wound

Study Results

No Results Posted as of Jul 14, 2021