Intro

ClearSight LLC is proud to announce the ClearSight Intraocular Lens —        a revolutionary device designed to give ophthalmologists a comprehensive solution to reduce posterior capsule opacification. The ClearSight IOL features Sharklet, a micropattern designed to redirect cellular migration away from the field of vision.

The ClearSight IOL has distinct features each designed for a specific purpose:

  • The optic is designed to extend the depth of focus without the need for axial movement.

  • The material is specifically formulated to be free of glistenings.

  • The outer portion of the lens has a 360⁰ square-edge micropatterned membrane preventing LEC migration responsible for PCO formation.


Cataracts

According to the World Health Organization, cataract is the leading cause of blindness, with over 20 million people affected in 2010. While age is the leading cause, younger people can develop cataract through eye disease or injury.

Current treatment for cataracts is simple: the clouded lens is removed, and a new, artificial intraocular lens is inserted. After the surgery, cells migrate onto the new lens, making it cloudy. A followup procedure uses an Nd:YAG laser to remove the migrated cells. Unfortunately, these laser procedures are expensive and available to less than 1% of the world’s population. In 2012 alone, Medicare reimbursed more than $350 million for laser capsulotomy surgeries.

 

Technology

The ClearSight presbyopia-correcting IOL addresses the shortcomings of multifocal and accommodating IOLs through the use of a multi-pronged approach to deliver a lens with an extended depth of focus while eliminating factors that could affect lens performance.

 

Extended Depth of Focus

Current multifocal IOLs are based on integrating a few optical zones within the IOL surface to create a limited number of focal points on the cornea.  Each focal point offers corrected vision at a specific distance (near, intermediate, and far).  Accommodating IOLs are designed to simulate the performance of the young natural lens when the focus shifts from far to near or vice versa by allowing the IOL to move within the eye.  Neither type of lens performs satisfactorily.

The ClearSight IOL achieves extended depth of focus by smoothing the transitions between the optical zones. Using novel design concepts, this allows the focal plane to extend without the glares and halos traditionally associated with shifts in optical zones. This is achieved without requiring the lens to move, offering more dependable performance.

Anti-Glistening Material

The ClearSight IOL is made in a patented hydrophobic acrylic material that is formulated to eliminate glistenings. Currently, the two market-leading IOLs in the U.S. are plagued by the occurrence of glistenings in the material, which can sometimes affect visual quality. Our material eliminates this issue, providing a better platform for delivering a premium extended depth-of-field optic.

 

 

Designed to Prevent Lens Opacification

The ClearSight IOL is designed to prevent PCO.  A novel square-edge membrane fully surrounds and protects the optic against LEC migration. The membrane is printed with Sharklet, a micropattern designed to inhibit the migration of cells onto the new lens. In vitro studies revealed an 80% reduction in LEC migration, while in vivo studies demonstrated 100% reduction in visually significant PCO in rabbit eyes. These results signify a breakthrough in PCO prevention.

Research

Magin et al – Micropatterned Protective Membranes Inhibit Lens Epithelial Cell Migration in Posterior Capsule Opacification Model
  • This piece, published in Translational Vision Science & Technology, explains the effect that the Sharklet micropattern has on cells that cause PCO

  • For more information about Sharklet, visit www.sharklet.com

Kramer et al – Evaluation of stability and capsular bag opacification with a foldable intraocular lens coupled with a protective membrane in the rabbit model
  • In this in vivo study, experts at the University of Utah show that PCO was reduced in rabbits with 100% reduction of clinically significant PCO.

  • For more information, visit the Journal of Cataract and Refractive Surgery.

Team

Mark Spiecker
Mark SpieckerChairman, Board of Directors
Mark Spiecker is chairman of the ClearSight board of directors. He provides guidance and assistance with business development activities for the company. Mark is also the CEO for parent company Sharklet Technologies, Inc. where he guides a team of scientists, business development professionals and product developers who are focused on Sharklet™ – the world’s first and only micropattern based on the bioadhesion-controlling properties of sharkskin.
Full Bio
Khalid Mentak, PhD
Khalid Mentak, PhDChief Executive Officer
Dr. Mentak has extensive experience in building medical device companies from the ground up. He founded and led several companies in the ophthalmic space including Surgidev Corporation, Advanced Vision Science, Inc. (AVS) , and Adoptics Ltd. Dr. Mentak is the founder and president of Key Medical Technologies, Inc., a privately owned company specializing in developing and licensing novel technologies for ophthalmic applications.
Full Bio
Kevin H. Cuevas, MD
Kevin H. Cuevas, MDChief Medical Officer
Dr. Cuevas holds some of the original patents for the ClearSight IOL design and is a co-founder of the company. He is the founder and former Medical Director of Rocky Mountain Ophthalmology, one of the leading high-volume cataract practices in the country, where he is also a practicing ophthalmologist. Dr. Cuevas serves as Partner and Chief Medical Officer (CMO) for ClearSight LLC and is the inventor of the patented ClearSight IOL device.
Full Bio
Shravanthi Reddy, PhD
Shravanthi Reddy, PhDChief Operating Officer
Dr. Reddy serves as ClearSight’s Chief Operating Officer. She is responsible for strategic planning for the company’s efforts to move forward with product R&D, regulatory strategy, and path to market. As VP of R&D for parent company Sharklet Technologies, Inc., she is instrumental in securing licensing deals with strategic partners for use of the Sharklet micropattern on medical devices.
Full Bio
Kevin Harris
Kevin HarrisDirector of R&D
Mr. Harris is ClearSight’s Director of R&D, and oversees daily execution of the ClearSight IOL development, manufacturing, and testing efforts. He brings medical device development experience, including holding the engineering lead position for the Sharklet-patterned Foley catheter for Cook Medical.
Full Bio
Jeannie Cecka
Jeannie CeckaDirector of Regulatory Affairs
Ms. Cecka is ClearSight’s Director of Regulatory Affairs, bringing many years of experience in Ophthalmic device market approvals and clinical trials with her. She has been involved with taking products through US and European market approval processes for both large and small companies, including Abbott Medical Optics (AMO), Hoya Surgical, Allergan, Baxter, PowerVision, TrueVision, and Glaukos. These roles have spanned from Director of Clinical Affairs to Director of Regulatory and Quality Affairs.
Full Bio

Contact Us

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Contact Information

Address

12635 E. Montview Boulevard

Suite 155

Aurora, CO 80045

Email

info@sharklet.com

Phone

720.859.4070

Web

www.clearsightiol.com