- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04082273
Comparison of Femto-laser and Manually Created Clear Corneal Incisions During Cataract Surgery (Z8_CCI)
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Bojan Pajic, MD, PhD
- Phone Number: +41 62 765 60 80
- Email: bojan.pajic@orasis.ch
Study Locations
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Aargau
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Reinach AG, Aargau, Switzerland, 5734
- Recruiting
- Augenklinik ORASIS AG
-
Contact:
- Bojan Pajic, MD, PhD
- Phone Number: +41 62 765 60 80
- Email: bojan.pajic@orasis.ch
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
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.
|
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.
|
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 visual acuity (LogMAR)
Time Frame: Baseline = Pre-operative, Follow-up = 12 days, 4 weeks and 6 weeks after surgery
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Baseline = Pre-operative, Follow-up = 12 days, 4 weeks and 6 weeks after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
|
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
|
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Ultrasound total time (US)
Time Frame: Baseline = Treatment day
|
Baseline = Treatment day
|
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Achieved CCI architecture
Time Frame: Baseline = Treatment day
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Presence of Descemet membrane detachment, posterior and anterior wound gape, if present size) will be analyzed on OCT images
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Baseline = Treatment day
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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
|
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FEMTO LDV Z8 OCT auto - detection accuracy
Time Frame: Baseline = Treatment day
|
Analyzed on intra-operative Z8 OCT images
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Baseline = Treatment day
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Bojan Pajic, MD, PhD, Augenklinik ORASIS AG
Publications and helpful links
General Publications
- 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.
- Brian G, Taylor H. Cataract blindness--challenges for the 21st century. Bull World Health Organ. 2001;79(3):249-56. Epub 2003 Jul 7.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CPFEM-0005-CH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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