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Precision Pulse Capsulotomy: Preclinical Safety and Performance of a New Capsulotomy Technology

Significance Statement

The ability to reproducibly automate a perfectly sized and circular capsulotomy has spurred much of the current clinical interest in femtosecond laser assisted cataract surgery (FLACS). Compared to manual continuous curvilinear capsulorhexis (CCC), the femtosecond laser capsulotomy (FSLC) is highly reproducible, uniformly more circular, and has a more precise diameter. However, this comes at a much higher capital and procedural cost and disrupts the normal surgical workflow because the FLACS steps cannot be performed within the usual operative sequence. Furthermore, differing national regulations may ban or restrict the ability to balance bill patients for the additional costs associated with FLACS. An important concern has arisen from published reports of an increased rate of anterior capsule tears following FSLC1,2. Scanning electron microscopy (SEM) of FSLC anterior capsule buttons demonstrates a rougher edge, when compared to manual CCC specimens. In addition, SEM analysis also reveals scattered aberrant laser shots that may be explained by microscopic eye movements occurring during the FSLC step1. These might be postulated to predispose focal areas of the anterior capsular rim to radial tears caused by subsequent surgical forces.

Mynosys (Fremont, California) has developed a novel capsulotomy method and technology called Precision Pulse Capsulotomy (PPC) and trade named Zepto. A disposable handpiece and nano-engineered capsulotomy tip are powered by a small console to automatically and instantaneously create a perfectly circular capsulotomy of a precise pre-designed diameter. The tip consists of a circular nitinol ring surrounded by a thin silicone cover shaped like a miniature inverted frying pan. Nitinol is a shape memory alloy which means that a 5.0 mm diameter ring can be compressed and deformed for insertion through a clear corneal incision, but will then re-assume its natural circular shape once it emerges inside the anterior chamber (AC). After filling the AC with ophthalmic viscosurgical device (OVD), a retractable metal push rod elongates the ring and silicone shell into a narrower profile that can be inserted through the clear corneal incision. After retracting this push rod, the compressed tip resumes its native circular shape within the AC.

The surgeon gently positions the ring and surrounding suction cup onto the anterior capsular surface prior to applying a small amount of suction via the external console. Only slight suction is needed to appose the anterior capsule against the bottom edge of the nitinol ring, which has been precisely engineered at the micron scale to enable uniform capsule cutting. A rapid series of microsecond-long electrical pulses is used to create the capsulotomy. Phase transition of water molecules trapped between the capsule and nitinol edge cause the stretched capsular membrane to abruptly split circumferentially all at once. Unlike the sequential circular path of a manual or FSLC, the PPC technology mechanically and simultaneously cleaves all 360 degrees of the apposed capsule without cauterizing it. Collateral ocular tissue safety is achieved through two design features. First, the application of energy is extremely brief and confined only to the microscopic edge of the nitinol ring. Second, during activation the nitinol ring is completely covered by the silicone suction cup and further insulated by the surrounding OVD.

This device has been developed through extensive testing in animal and human cadaver eyes3. Miyake Apple view video imaging shows insignificant zonular traction while performing PPC in both rabbit and human cadaver eyes. Pre-clinical performance and safety testing in live rabbits, including intraoperative thermocouple measurements, slit lamp evaluation and histopathology, has been performed at the Moran Eye Center.

On SEM of human cadaver capsules, the PPC capsulotomy edge is smoother and more defect-free than that of a manual CCC.  We have performed extensive testing of capsulotomy edge strength by comparing PPC to both manual CCC and FSLC in paired fellow human cadaver eyes. The PPC edge is consistently stronger than either alternative.

The obvious potential advantage of Zepto PPC would be its ability to reproduce automate the capsulotomy step with a disposable instrument that is inserted in the conventional surgical sequence and in lieu of using capsulorhexis forceps. Surgeons would welcome a method to assure a perfectly sized and round capsulotomy without the workflow challenges and increased procedural time of FLACS. As with FSLC, popular indications would be for complicated cases or when using premium refractive IOLs. The lower cost should ideally make PPC available to all patients independent of affordability and regional regulations regarding balance billing. Surgeons might also opt for the efficiency of using Zepto routinely rather than only in select cases, particularly if it is on average faster and more consistent than manual capsulorhexis.

Because it is an integrated step during conventional phacoemulsification, PPC can be performed after insertion of iris expansion devices for small pupils. The tip is also designed to allow insertion through a smaller pupil if necessary. It does not require additional surgical steps such as capsular staining. If the PPC edge is indeed more tear resistant, this might improve surgical safety by reducing anterior and posterior capsular tears. Finally, the transparent silicone suction cup has a central window that is designed to permit patient fixation on the microscope light filament during positioning of the device. Being able to center the capsulotomy on the visual axis would be advantageous when implanting refractive lens implants such as toric and multifocal IOLs.

The PPC device name was chosen because in the metric scale, zepto is one million times smaller than femto. Both the small size of the instrument and the several millisecond speed of capsulotomy creation inspired this name. The device is CE mark approved, and has been submitted for FDA 510(k) approval.

REFERENCES:

  1. Abell RG, Davies PE, Phelan D, et al. Anterior capsulotomy integrity after femtosecond laser-assisted cataract surgery. Ophthalmology 2014;121:17-24.
  2. Chang JS, Chen IN, Chan WM, et al. Initial evaluation of a femtosecond laser system in cataract surgery. J Cataract Refract Surg 2014;40:29-36.
  3. Chang DF, Mamalis N, Werner L. Precision Pulse Capsulotomy – Preclinical Safety and Performance of a New Capsulotomy Technology. Ophthalmology 2016; 123:255-264.
  4. Thompson VM, Berdahl JP, Solano JM, Chang DF. Comparison of manual, femtosecond laser, and precision pulse capsulotomy edge tear in paired human cadaver eyes. Ophthalmology 2016;123:265-274.

Dr. Chang is clinical professor at the University of California, San Francisco. His relevant financial disclosure is that he has received compensation as a consultant for Mynosys, AMO, and LensAR. 

Precision Pulse Capsulotomy-Global Medical Discovery

About The Author

David F. Chang, MD is a Summa Cum Laude graduate of Harvard College and Harvard Medical School. He completed his ophthalmology residency at the University of California, San Francisco where he is now a clinical professor. Dr. Chang has been on the ASCRS Board and Executive Committee since 2009 and served as the 2012-2013 president. He is immediate past chair of the AAO Cataract PPP Panel and in 2009 completed his 5-year term as chair of the AAO Annual Meeting Program Committee. Dr. Chang also co-chairs the ASCRS Foundation. He has served as chief medical editor of EyeWorld and co-chief medical editor for Cataract and Refractive Surgery Today, In 2006, Dr. Chang became only the third ophthalmologist to ever receive the Charlotte Baer Award honoring the outstanding clinical faculty member at the UCSF Medical School. He has received the highest honor for cataract surgery or for an international ophthalmologist from the following organizations: ASCRS (Binkhorst Medal), AAO (Kelman Lecture), Asia Pacific Association of Cataract & Refractive Surgery (Lim Medal), United Kingdom and Ireland Society of Cataract & Refractive Surgery (Rayner Medal), Canadian Society of Cataract and Refractive Surgery (Award of Excellence/Stein Lecture), All India Ophthalmology Society (President’s Lecture), Indian Intraocular Implant & Refractive Society (Gold Medal), Italian Ophthalmological Society (Strampelli Medal), Royal Australia and New Zealand College of Ophthalmologists (Gregg Medal), and the Asia-Pacific Academy of Ophthalmology (Jose Rizal International Medal). In 2014, he was also voted the 5th most influential ophthalmologist in the world by the international readership of The Ophthalmologist.

Journal Reference

Ophthalmology. 2016 Feb;123(2):255-64.

Chang DF1, Mamalis N2, Werner L2.

Show Affiliations
  1. Altos Eye Physicians, Los Altos, California. Electronic address: [email protected]
  2. John A. Moran Eye Center, University of Utah, Salt Lake City, Utah.

Abstract

PURPOSE:

To assess the preclinical safety and performance of a new precision pulse capsulotomy (PPC) method.

DESIGN:

Human cadaver eye studies and surgical, slit-lamp, and histopathologic evaluation in a consecutive series of 20 live rabbits.

PARTICIPANTS:

Human cadaver eyes and New Zealand white rabbits.

METHODS:

Precision pulse capsulotomy uses a highly focused, fast, multipulse, low-energy discharge to produce a perfectly round anteriorcapsulotomy instantaneously and simultaneously along all 360°. Capsulotomies are performed using a disposable handpiece with a soft collapsible tip and circular nitinol cutting element. Miyake-Apple imaging and scanning electron microscopy (SEM) of PPC were conducted in human cadaver eyes. Surgical, postoperative slit-lamp, and histopathologic assessments of PPC were performed in 20 live rabbits and were compared with manual continuous curvilinear capsulorrhexis (CCC) in the fellow eye. Anterior chamber (AC) thermocouple temperature measurements were evaluated in a subset of rabbit eyes.

MAIN OUTCOME MEASURES:

Capsulotomy edge circularity, SEM morphologic features and zonular movement with PPC in human cadaver eyes. Anterior chamber temperature during PPC and grading of ocular inflammation, corneal endothelial damage, anterior capsular opacification (ACO), and posterior capsular opacification (PCO).

RESULTS:

Miyake-Apple imaging showed minimal zonular stress, and thermocouple measurements demonstrated negligible AC temperature changes during PPC. Precision pulse capsulotomy produced round, complete capsulotomies in all 20 rabbit eyes, leading to successful in-the-bag intraocular lens (IOL) implantation. Slit-lamp examinations at 3 days and 1, 2, and 4 weeks after surgery showed no significant differences between PPC and CCC in corneal edema, AC inflammatory reaction, capsular fibrosis, ACO, and PCO. Postmortem studies showed no difference in the corneal endothelium between PPC and CCC eyes. All IOLs were well centered in PPC eyes, and histopathologic analysis showed no greater inflammatory infiltrates.

CONCLUSIONS:

Precision pulse capsulotomy is a new method to automate consistent creation of a perfectly circular anterior capsulotomy with a disposable handheld instrument that can be used in the normal phacoemulsification surgical sequence. Compared with CCC in fellow rabbit eyes, PPC was equally safe and showed no greater zonular stress compared with CCC in human cadaver eyes. Human cadaver eye SEM showed a much smoother capsulotomy edge compared to those produced by femtosecond laser.

Copyright © 2016 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

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