Implantable Phakic Lens (IPCL) VS Implantable Collamer Lens

Myopia Clinical Trial

Official title:

Comparison Between Implantable Phakic Intraocular Lens and Implantable Collamer Lens in Treatment of Myopia in Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04624035
• Other study ID #: ICL vs IPCL
• Status: Recruiting
• Phase: N/A
• Start date: October 10, 2020
• Est. completion date: October 2021

Study information

• Verified date: October 2020
• Source: Assiut University
• Contact: Mahmoud F Rateb, MD
• Phone: ?+20 100 8348480?
• Email: rateb[@]aun.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Phakic intraocular lenses (pIOL) of different designs and materials have been used effectively instead of corneal refractive surgery in certain situations. The pIOL exhibits a number of advantages over corneal techniques as it is suitable for high myopes, with lower production of aberrations, and superior contrast sensitivity. Keeping the accommodation is its definite lead over refractive lens exchange. The Visian implantable collamer lens (ICL; Staar Surgical, Monrovia, CA), a posterior chamber pIOL, has been stated to be useful for the correction of high myopia. Nevertheless, as an intraocular procedure, it is associated with a risk of complications as probable injury to anterior segment, retinal detachment and endophthalmitis.

The Implantable Phakic Contact Lens (IPCL V2, Caregroup Sight Solutions, India) has been developed as an alternative for the ICL, at a noticeable financial advantage. Furthermore, the highestmyopic correction which is instantly accessible with ICL is -18.0 D. Meanwhile, IPCL can provide correction higher degrees up to -30.0 D.

Former researches have been made to assess the safety and efficiency of ICL implantation, to evaluate various devices for anterior segment imaging postoperatively and to identify changes in anterior segment after surgery. A recent study determined the safety of the IPCL over a minimum follow-up period of one year. In this work the investigators aimed to compare the refractive results and the adverse effects of the IPCL and the ICL in treatment of myopia in adults.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• myopia of more than 6 diopter

• central anterior chamber depth more than 2.8 mm

Exclusion Criteria:

• unstable refraction

• any other ocular disease

• any systemic disease

Related Conditions & MeSH terms

• Myopia

Intervention

Procedure:
• Implantable Collamer Lens (ICL) in treatment of myopia in adults.
ICL Group: After mydriatic eye drops and topical anesthesia instillation, a 3-mm temporal corneal incision was done. Viscoelastic material was injected in the anterior chamber (AC). An injector cartridge (STAAR Surgical) was used to insert the ICL V4c model with central hole). The four footplates of the ICL were positioned on the ciliary sulcus at the 180° axis. Viscoelastic material was entirely taken away.
• Implantable Intraocular Lens (IPCL) in treatment of myopia in adults.
IPCL Group: Topical anesthetic and mydriatic agents were instilled before surgery. Using peripulbar anaesthesia, the IPCL (V2 model with central hole) was implanted into the AC through a 3 mm clear corneal incision after viscoelastic material injection. The footplates were subsequently tucked behind the iris, followed by a thorough viscoelastic removal.

Locations

Country	Name	City	State
Egypt	Tiba eye center	Asyut
Egypt	Al Masa eye center	Banha

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (9)

Elmohamady MN, Abdelghaffar W. Anterior Chamber Changes After Implantable Collamer Lens Implantation in High Myopia Using Pentacam: A Prospective Study. Ophthalmol Ther. 2017 Dec;6(2):343-349. doi: 10.1007/s40123-017-0109-3. Epub 2017 Sep 20. — View Citation

Fernandes P, González-Méijome JM, Madrid-Costa D, Ferrer-Blasco T, Jorge J, Montés-Micó R. Implantable collamer posterior chamber intraocular lenses: a review of potential complications. J Refract Surg. 2011 Oct;27(10):765-76. doi: 10.3928/1081597X-20110617-01. Epub 2011 Jun 30. Review. — View Citation

Igarashi A, Kamiya K, Shimizu K, Komatsu M. Visual performance after implantable collamer lens implantation and wavefront-guided laser in situ keratomileusis for high myopia. Am J Ophthalmol. 2009 Jul;148(1):164-70.e1. doi: 10.1016/j.ajo.2009.02.001. Epub 2009 Apr 17. — View Citation

Kamiya K, Igarashi A, Shimizu K, Matsumura K, Komatsu M. Visual performance after posterior chamber phakic intraocular lens implantation and wavefront-guided laser in situ keratomileusis for low to moderate myopia. Am J Ophthalmol. 2012 Jun;153(6):1178-86.e1. doi: 10.1016/j.ajo.2011.12.005. Epub 2012 Feb 23. — View Citation

Pineda-Fernández A, Jaramillo J, Vargas J, Jaramillo M, Jaramillo J, Galíndez A. Phakic posterior chamber intraocular lens for high myopia. J Cataract Refract Surg. 2004 Nov;30(11):2277-83. — View Citation

Sachdev G, Ramamurthy D. Long-term safety of posterior chamber implantable phakic contact lens for the correction of myopia. Clin Ophthalmol. 2019 Jan 7;13:137-142. doi: 10.2147/OPTH.S185304. eCollection 2019. — View Citation

Sanders D, Vukich JA. Comparison of implantable collamer lens (ICL) and laser-assisted in situ keratomileusis (LASIK) for low myopia. Cornea. 2006 Dec;25(10):1139-46. — View Citation

Stulting RD, John ME, Maloney RK, Assil KK, Arrowsmith PN, Thompson VM; U.S. Verisyse Study Group. Three-year results of Artisan/Verisyse phakic intraocular lens implantation. Results of the United States Food And Drug Administration clinical trial. Ophthalmology. 2008 Mar;115(3):464-472.e1. Epub 2007 Nov 26. — View Citation

Zhang J, Luo HH, Zhuang J, Yu KM. Comparison of anterior section parameters using anterior segment optical coherence tomography and ultrasound biomicroscopy in myopic patients after ICL implantation. Int J Ophthalmol. 2016 Jan 18;9(1):58-62. doi: 10.18240/ijo.2016.01.10. eCollection 2016. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Refractive outcome	Postoperative refractive error measured in spherical equivalent	12 months
Primary	Visual outcome	Uncorrected distance and near vision using Snellen's chart and using decimal fractions	12 months
Secondary	Adverse reactions	adverse reactions will be recorded including intraocular inflammation, corneal endothelial changes and lens opactification	12 months