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

Cataract Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04082273
• Other study ID #: CPFEM-0005-CH
• Status: Recruiting
• Phase: N/A
• Start date: August 26, 2019
• Est. completion date: December 30, 2021

Study information

• Verified date: July 2021
• Source: Ziemer Ophthalmic Systems AG
• Contact: Bojan Pajic, MD, PhD
• Phone: +41 62 765 60 80
• Email: bojan.pajic[@]orasis.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 94
• Est. completion date: December 30, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Surgical Wound

Intervention

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

Locations

Country	Name	City	State
Switzerland	Augenklinik ORASIS AG	Reinach AG	Aargau

Sponsors (1)

Lead Sponsor	Collaborator
Ziemer Ophthalmic Systems AG

Country where clinical trial is conducted

Switzerland, 

References & Publications (16)

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. — View 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. — View 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. Review. — View 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. — View 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. — View 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. — View 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. — View 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. Review. — View 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. Review. — View 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. — View Citation

Nagy ZZ, Kránitz K, Takacs AI, Miháltz K, Kovács 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. — View 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®. Ophthalmology. 2017 Feb;124(2):P1-P119. doi: 10.1016/j.ophtha.2016.09.027. Epub 2016 Oct 13. Review. — View 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. — View 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. — View 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. — View 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. Review. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Central corneal thickness (CCT)		Baseline = Pre-operative, Follow-up = 1 day, 12 days, 4 weeks and 6 weeks after surgery
Secondary	Endothelial cell density (ECD)		Baseline = Pre-operative, Follow-up = 1 day, 12 days, 4 weeks and 6 weeks after surgery
Secondary	Effective Phacoemulsification Time (EPT)		Baseline = Treatment day
Secondary	Ultrasound total time (US)		Baseline = Treatment day
Secondary	Achieved CCI architecture	Presence of Descemet membrane detachment, posterior and anterior wound gape, if present size) will be analyzed on OCT images	Baseline = Treatment day
Secondary	Intra- and post-operative CCI related complications rate		Baseline = Treatment day, Follow-up = 1 day, 12 days, 4 weeks and 6 weeks after surgery
Secondary	FEMTO LDV Z8 OCT auto - detection accuracy	Analyzed on intra-operative Z8 OCT images	Baseline = Treatment day