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

Primary Purpose

Cataract

Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Femtosecond Laser for Cataract Surgery
Conventional Cataract Surgery
Sponsored by
Ziemer Ophthalmic Systems AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring Induced corneal Astigmatism, Clear corneal incisions, Femto-laser

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Augenklinik ORASIS AGRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Femtosecond Laser for Cataract Surgery

Conventional Cataract Surgery

Arm Description

Capsulotomy, lens fragmentation and Clear Corneal Incisions with FEMTO LDV Z8, followed by ultrasound phacoemulsification and IOL implantation.

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.

Outcomes

Primary Outcome Measures

Change from baseline (pre-operative) Surgically Induced corneal Astigmatism (SIA) measured by visual acuity (LogMAR)

Secondary Outcome Measures

Change from baseline (pre-operative) Higher-order aberrations (HOAs) measured by the Shack-Hartmann aberrometry method
Central corneal thickness (CCT)
Endothelial cell density (ECD)
Effective Phacoemulsification Time (EPT)
Ultrasound total time (US)
Achieved CCI architecture
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
FEMTO LDV Z8 OCT auto - detection accuracy
Analyzed on intra-operative Z8 OCT images

Full Information

First Posted
September 2, 2019
Last Updated
July 13, 2021
Sponsor
Ziemer Ophthalmic Systems AG
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1. Study Identification

Unique Protocol Identification Number
NCT04082273
Brief Title
Comparison of Femto-laser and Manually Created Clear Corneal Incisions During Cataract Surgery
Acronym
Z8_CCI
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 26, 2019 (Actual)
Primary Completion Date
November 30, 2021 (Anticipated)
Study Completion Date
December 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ziemer Ophthalmic Systems AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Induced corneal Astigmatism, Clear corneal incisions, Femto-laser

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
94 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Femtosecond Laser for Cataract Surgery
Arm Type
Experimental
Arm Description
Capsulotomy, lens fragmentation and Clear Corneal Incisions with FEMTO LDV Z8, followed by ultrasound phacoemulsification and IOL implantation.
Arm Title
Conventional Cataract Surgery
Arm Type
Active Comparator
Arm Description
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 Type
Device
Intervention Name(s)
Femtosecond Laser for Cataract Surgery
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Conventional Cataract Surgery
Intervention Description
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 Measure Information:
Title
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 Measure Information:
Title
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
Title
Central corneal thickness (CCT)
Time Frame
Baseline = Pre-operative, Follow-up = 1 day, 12 days, 4 weeks and 6 weeks after surgery
Title
Endothelial cell density (ECD)
Time Frame
Baseline = Pre-operative, Follow-up = 1 day, 12 days, 4 weeks and 6 weeks after surgery
Title
Effective Phacoemulsification Time (EPT)
Time Frame
Baseline = Treatment day
Title
Ultrasound total time (US)
Time Frame
Baseline = Treatment day
Title
Achieved CCI architecture
Description
Presence of Descemet membrane detachment, posterior and anterior wound gape, if present size) will be analyzed on OCT images
Time Frame
Baseline = Treatment day
Title
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
Title
FEMTO LDV Z8 OCT auto - detection accuracy
Description
Analyzed on intra-operative Z8 OCT images
Time Frame
Baseline = Treatment day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bojan Pajic, MD, PhD
Phone
+41 62 765 60 80
Email
bojan.pajic@orasis.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bojan Pajic, MD, PhD
Organizational Affiliation
Augenklinik ORASIS AG
Official's Role
Principal Investigator
Facility Information:
Facility Name
Augenklinik ORASIS AG
City
Reinach AG
State/Province
Aargau
ZIP/Postal Code
5734
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bojan Pajic, MD, PhD
Phone
+41 62 765 60 80
Email
bojan.pajic@orasis.ch

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
11285671
Citation
Brian G, Taylor H. Cataract blindness--challenges for the 21st century. Bull World Health Organ. 2001;79(3):249-56. Epub 2003 Jul 7.
Results Reference
background
PubMed Identifier
20000286
Citation
Nagy Z, Takacs A, Filkorn T, Sarayba M. Initial clinical evaluation of an intraocular femtosecond laser in cataract surgery. J Refract Surg. 2009 Dec;25(12):1053-60. doi: 10.3928/1081597X-20091117-04.
Results Reference
background
PubMed Identifier
21150606
Citation
He L, Sheehy K, Culbertson W. Femtosecond laser-assisted cataract surgery. Curr Opin Ophthalmol. 2011 Jan;22(1):43-52. doi: 10.1097/ICU.0b013e3283414f76.
Results Reference
background
PubMed Identifier
23370418
Citation
Trikha S, Turnbull AM, Morris RJ, Anderson DF, Hossain P. The journey to femtosecond laser-assisted cataract surgery: new beginnings or a false dawn? Eye (Lond). 2013 Apr;27(4):461-73. doi: 10.1038/eye.2012.293. Epub 2013 Feb 1.
Results Reference
background
PubMed Identifier
24269139
Citation
Chang JS, Chen IN, Chan WM, Ng JC, Chan VK, Law AK. Initial evaluation of a femtosecond laser system in cataract surgery. J Cataract Refract Surg. 2014 Jan;40(1):29-36. doi: 10.1016/j.jcrs.2013.08.045. Epub 2013 Nov 22.
Results Reference
background
PubMed Identifier
24568722
Citation
Grewal DS, Basti S. Comparison of morphologic features of clear corneal incisions created with a femtosecond laser or a keratome. J Cataract Refract Surg. 2014 Apr;40(4):521-30. doi: 10.1016/j.jcrs.2013.11.028. Epub 2014 Feb 22.
Results Reference
background
PubMed Identifier
25261391
Citation
Baig NB, Cheng GP, Lam JK, Jhanji V, Chong KK, Woo VC, Tham CC. Intraocular pressure profiles during femtosecond laser-assisted cataract surgery. J Cataract Refract Surg. 2014 Nov;40(11):1784-9. doi: 10.1016/j.jcrs.2014.04.026. Epub 2014 Sep 24.
Results Reference
background
PubMed Identifier
23988242
Citation
Reddy KP, Kandulla J, Auffarth GU. Effectiveness and safety of femtosecond laser-assisted lens fragmentation and anterior capsulotomy versus the manual technique in cataract surgery. J Cataract Refract Surg. 2013 Sep;39(9):1297-306. doi: 10.1016/j.jcrs.2013.05.035.
Results Reference
background
PubMed Identifier
21688765
Citation
Nagy ZZ, Kranitz K, Takacs AI, Mihaltz K, Kovacs I, Knorz MC. Comparison of intraocular lens decentration parameters after femtosecond and manual capsulotomies. J Refract Surg. 2011 Aug;27(8):564-9. doi: 10.3928/1081597X-20110607-01. Epub 2011 Jun 20.
Results Reference
background
PubMed Identifier
21700099
Citation
Friedman NJ, Palanker DV, Schuele G, Andersen D, Marcellino G, Seibel BS, Batlle J, Feliz R, Talamo JH, Blumenkranz MS, Culbertson WW. Femtosecond laser capsulotomy. J Cataract Refract Surg. 2011 Jul;37(7):1189-98. doi: 10.1016/j.jcrs.2011.04.022. Erratum In: J Cataract Refract Surg. 2011 Sep;37(9):1742.
Results Reference
background
PubMed Identifier
21084720
Citation
Palanker DV, Blumenkranz MS, Andersen D, Wiltberger M, Marcellino G, Gooding P, Angeley D, Schuele G, Woodley B, Simoneau M, Friedman NJ, Seibel B, Batlle J, Feliz R, Talamo J, Culbertson W. Femtosecond laser-assisted cataract surgery with integrated optical coherence tomography. Sci Transl Med. 2010 Nov 17;2(58):58ra85. doi: 10.1126/scitranslmed.3001305.
Results Reference
background
PubMed Identifier
25525326
Citation
Pajic B, Vastardis I, Gatzioufas Z, Pajic-Eggspuehler B. First experience with the new high-frequency femtosecond laser system (LDV Z8) for cataract surgery. Clin Ophthalmol. 2014 Dec 8;8:2485-9. doi: 10.2147/OPTH.S72983. eCollection 2014.
Results Reference
background
PubMed Identifier
23078347
Citation
Abell RG, Kerr NM, Vote BJ. Femtosecond laser-assisted cataract surgery compared with conventional cataract surgery. Clin Exp Ophthalmol. 2013 Jul;41(5):455-62. doi: 10.1111/ceo.12025. Epub 2012 Dec 10.
Results Reference
background
PubMed Identifier
29738588
Citation
Ferreira TB, Ribeiro FJ, Pinheiro J, Ribeiro P, O'Neill JG. Comparison of Surgically Induced Astigmatism and Morphologic Features Resulting From Femtosecond Laser and Manual Clear Corneal Incisions for Cataract Surgery. J Refract Surg. 2018 May 1;34(5):322-329. doi: 10.3928/1081597X-20180301-01.
Results Reference
background
PubMed Identifier
28242111
Citation
Liu YC, Wilkins M, Kim T, Malyugin B, Mehta JS. Cataracts. Lancet. 2017 Aug 5;390(10094):600-612. doi: 10.1016/S0140-6736(17)30544-5. Epub 2017 Feb 25.
Results Reference
background
PubMed Identifier
27745902
Citation
Olson RJ, Braga-Mele R, Chen SH, Miller KM, Pineda R 2nd, Tweeten JP, Musch DC. Cataract in the Adult Eye Preferred Practice Pattern(R). Ophthalmology. 2017 Feb;124(2):P1-P119. doi: 10.1016/j.ophtha.2016.09.027. Epub 2016 Oct 13. No abstract available.
Results Reference
background

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

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