Sheraz M. Daya MD wins Best Paper of Session (BPOS) Award at the ASCRS in San Diego

In his comparison of anterior capsulotomy techniques: continuous curvilinear capsulorhexis (CCC), femtosecond laser-assisted capsulotomy (FLACS) and Selective Laser Capsulotomy (SLC) , Mr Daya presented on the comparison of elasticity and fracture strength of all 3 techniques. The presentation derived from a study recently published in the British Journal of Ophthalmology and concludes:

  • SLC is significantly stronger than both CCC and FLACS
  • CCC significantly stronger than FLACS (data that had not previously been evaluated in human eyes)
  • SLC strength may be accounted for by SEM findings

The full presentation is available for download below:

Efficacy and safety of a new selective laser device to create anterior capsulotomies in cataract patients

Presented in part at the ASCRS•ASOA Annual Meeting, Washington, DC, USA, April 2018
Authors: Pavel Stodulka MD, PhD, FEBOS-CR1Richard Packard MD, FRCS, FRCOphth2David Mordaunt PhD3

1. Charles University, Prague, Czech Republic
2. Arnott Eye Associates, London, United Kingdom
3. EXCEL-LENS, Inc., Los Gatos, California, USA

Purpose

To compare the efficacy and safety of anterior capsulotomy creation with a new selective laser device (CAPSULaser) with those of manual capsulotomies.

Setting

GEMINI Eye Clinic, Zlin, Czech Republic.

Design

Prospective case series.

Methods

Patients were placed in cohorts based on age and cataract grade and randomly allocated to have laser capsulotomy or manual continuous curvilinear capsulorhexis (CCC). The anterior capsule was stained with microfiltered trypan blue 0.4%. The anterior capsulotomy was created with the laser device focused on the anterior capsule through a custom patient interface lens. Intraoperative video analysis with the use of an intraocular ruler and postoperative examinations were used to assess safety and efficacy (accuracy of capsulotomy size, circularity, centration).

Results

No intraoperative complications occurred in the laser group or the manual group. All capsulotomies in the laser group were free-floating with no tags or tears. The mean capsulotomy diameter was 5.03 mm overall (range 4.8 to 5.2 mm, laser group; 4.4 to 5.8 mm, manual group). In the laser group, all the capsulotomies were within 0.1 mm ± 0.1 (SD) of the target. The circularity accuracy was greater than 99.0% ± 1.0%; the mean centration of the capsulotomy in relation to the intraocular lens (IOL) was 0.1 ± 0.1 mm. All parameters were statistically significant (P < .01). The IOL–capsulotomy overlap was 360 degrees in all laser cases.

Conclusions

Selective laser capsulotomy using a new proprietary trypan blue formulation was safe and effective in cataract surgery. The sizing, circularity, and centration of the laser capsulotomy were more accurate than those of the manual CCC, resulting in consistent 360-degree IOL coverage.

Comparison of anterior capsulotomy techniques: continuous curvilinear capsulorhexis, femtosecond laser-assisted capsulotomy and selective laser capsulotomy

Authors: Sheraz M. Daya, MD, FACP, FACS, FRCS(Ed),  Soon-Phaik Chee, FRCOphth, FRCS(Ed), FRCS(G), MMed(S’pore), Seng-Ei Ti, FRCS(Ed), MMed(S’pore),  Richard Packard, MD, FRCS, FRCOphth, David H. Mordaunt, PhD

Purpose To compare the anterior capsulotomy edge tear strength created by manual continuous curvilinear capsulorhexis (CCC), femtosecond laser-assisted capsulotomy (FLACS), and selective laser capsulotomy (SLC).

Setting Singapore National Eye Centre, Singapore and Excel-Lens, Livermore, California, USA.

Design Three armed study in paired human eyes.

Methods Capsulotomies were performed in 60 cadaver eyes of 30 donors using CCC, Victus Femtosecond Laser, (Bausch & Lomb, Rochester, New York, USA) or CAPSULaser, (Excel-Lens, Los Gatos, California, USA). Three pairwise study groups each involved 10 pairs of eyes. Study group 1: SLC eyes compared with fellow eyes with CCC. Study group 2: CCC eyes compared with fellow eyes with FLACS. Study group 3: FLACS eyes compared with fellow eyes with SLC.

A shoe-tree method was used to apply load to the capsulotomy edge, and Instron tensile stress instrument measured distension and threshold load applied to initiate capsule fracture. Relative fracture strengths and distension of CCC, FLACS and SLC were determined. Scanning electron microscopy (SEM) of capsule edges were reviewed

Results Anterior capsulotomies behave as non-linear elastic (elastomeric) systems when exposed to an external load. The pairwise study demonstrated that the SLC fracture strength was superior to that of CCC by a factor of 1.46-fold with SLC 277±38 mN versus CCC with 190±37 mN. Furthermore, CCC fracture strength was superior to that of FLACS by a factor of 1.28-fold with CCC 186 + 37 mN versus FLACS 145 ± 35 mN (p < 0.001). This was determined by statistical analysis utilising the Wilcoxon matched-pairs signed-ranks test and in accordance with the Consolidated Standards of Reporting Trials guidelines. The capsule edge of SLC on SEM demonstrated a rolled over edge anteriorly and an alteration of collagen.

Conclusions The strength of the capsulotomy edge for SLC was significantly stronger than that of CCC which and both were significantly stronger than FLACS. The relative strengths can be explained by SEM of each type of capsulotomy.

Parameters affecting anterior capsulotomy tear strength and distension

Authors: Sheraz M. Daya, MD, FACP, FACS, FRCS(Ed),  Soon-Phaik Chee, FRCOphth, FRCS(Ed), FRCS(G), MMed(S’pore), Seng-Ei Ti, FRCS(Ed), MMed(S’pore),  Richard Packard, MD, FRCS, FRCOphth, David H. Mordaunt, PhD

Purpose

To study the effects of anterior capsulotomy diameter and discontinuity on tear threshold load and distension for the technique of continuous curvilinear capsulorhexis (CCC).

Setting

Singapore National Eye Centre, Singapore, and CapsuLaser Inc., Livermore, California, USA.

Design

Two separate randomized pairwise cadaver eye preclinical studies.

Methods

Capsulotomies were performed in 40 cadaver eyes of 20 donors using CCC. The pairwise comparisons were divided into 2 study groups: Study A: Continuous versus discontinuous capsulotomies; Study B: Capsulotomy diameter of 5.0 mm and smaller versus diameters of 5.2 mm and larger. A shoe-tree method was used to apply load to the capsulotomy rim, and the Instron tensile stress instrument measured threshold load and distension to initiate a capsular tear. Wilcoxon matched-pairs signed-rank tests were performed to assess statistical superiority.

Results

In Study Group A, all pairs demonstrated that continuous capsulotomies were better than discontinuous capsulotomies for both the anterior tear threshold load and distension (P < .01). In Study Group B, 80% of the pairs demonstrated that diameters of 5.2 mm and larger were better than those of 5.0 mm and smaller diameter (P < .05).

Conclusions

Anterior capsulotomies behave as nonlinear elastic (elastomeric) systems when exposed to an external load and distension. This study demonstrated that continuous circular capsulotomies were more resistant to anterior tears than discontinuous capsulotomies. A point of irregularity or a defect in a capsulotomy rim has a high probability of being the tear initiation point. Furthermore, larger diameter capsulotomies were more resistant to anterior tears than smaller capsulotomies.

Dr Erik Mertens at ESCRS Capsulaser Symposium

ESCRS CAPSULaser® Symposium Series – Part 5 “Early Experience with CAPSULaser”

Dr Erik Mertens presents his first experiences with CAPSULaser and details a step by step guide to the selective laser capsulotomy procedure during the CAPSULaser symposium held at the ESCRS Vienna in September.

Dr Erik Mertens ESCR Symposium Capsulaser

Richard Packard ESCRS CAPSULaser Symposium

ESCRS CAPSULaser® Symposium Series – Part 4 “CE Study Overview ”

Mr Richard Packard explores the Efficacy & Safety profile of CAPSULaser as he shares the “CAPSULaser CE Study Overview”. In this presentation, Mr Packard concludes that the accuracy of diameter, circularity and centration is superior to the manual capsulotomy control group and that these results indicate that the selective laser capsulotomy performed by CAPSULaser may be an important factor in the ongoing improvement of outcomes with premium IOLs.

Coming Soon – to be released 29th November – Dr Erik Mertens presents the final instalment which outlines his “Early Impressions of CAPSULaser” and gives a step by step guide to its usage.

Richard Packard for Capsulaser

Dr Pavel Stodulka ESCRS CAPSULaser Symposium

ESCRS CAPSULaser® Symposium Series – Part3 “Clinical Experience with CAPSULaser”

Dr Pavel Stodulka was the first ophthalmologist in the world to use CAPSULaser and has been involved from the beginning in both the clinical use and the ongoing development of this Selective Laser Capsulotomy (SLC) technology. In this presentation Pavel presents his experience and gives some early insights to the importance of automated capsulotomy in the ongoing evolution of ever improving visual outcomes for patients.

Coming Soon – Part 4 to be released 22nd  November – Mr Richard Packard explores the Efficacy & Safety profile of CAPSULaser as he shares the “CAPSULaser CE Study Overview”

Dr Pavel Stodulka ESCRS CAPSULaser® Symposium Series Capsulaser

Mr Sheraz Daya ESCRS CAPSULaser Symposium

ESCRS CAPSULaser® Symposium Series – Part2 “Parameters Effecting Capsulotomy”

Mr Sheraz Daya presents “Parameters Effecting Capsulotomy”  comparing the elasticity and fracture strength of manual CCC, femtosecond laser and selective laser capsulotomies (SLC). The data presented by Mr Daya is part of a study performed by Professor Soon Phaik Chee at the Singapore National Eye Centre and in collaboration with Mr Richard Packard, Arnott Eye Associates , London demonstrating the benefits of SLC over both CCC and femtosecond laser in the construction of anterior capsulotomies.

Coming Soon – Part 3 to be released 15th November – Dr Pavel Stodulka presents his “Clinical Experience with CAPSULaser”

Mr Sheraz Daya

Professor Burkhard Dick - CAPSULaser Symposium Introduction

ESCRS CAPSULaser® Symposium Series – Part1

Los Gatos, CA – EXCEL-LENS, Inc. presents the CAPSULaser ESCRS symposium highlights in a 6 part series to be released weekly

Part 1 released today – The Introduction presented by Professor Burkhard Dick focuses on “From Capsulorhexis to Capsulotomy – Why CAPSULaser?”

Part 2 to be released 8th November – Mr Sheraz Daya shares “Parameters Effecting Capsulotomy”

Part 3 to be released 15th November – Dr Pavel Stodulka presents his “Clinical Experience with CAPSULaser”

Part 4 to be released 22nd November – Mr Richard Packard explores the Efficacy & Safety profile of CAPSULaser in giving a “CE Study Overview”

Part 5 to be released 29th November – Dr Erik Mertens presents the final instalment which outlines his “Early Impressions of CAPSULaser” and gives a step by step guide to its usage.

Professor Burkhard Dick - CAPSULaser Symposium Introduction

EXCEL- LENS, Inc. Announce CE Mark Approval for CAPSULaser® Selective Laser Capsulotomy (SLC) Device

Los Gatos, CA – EXCEL-LENS, Inc. announced the CE mark approval of CAPSULaser,

a selective laser that creates a capsulotomy during cataract surgery in just over a second. The laser energy is delivered in a continuous manner rather than a pulsed beam which can create tissue bridges.

In clinical studies CAPSULaser has demonstrated superior consistency compared to manual in creating a capsulotomy that is 100% free-floating and providing 100% 360° IOL coverage.

CAPSULaser offers the surgeon laser precision to pre-select the intended capsulotomy size from 4.5mm to 6.0mm in 0.1mm increments and to utilize the integrated patient fixation beam to center the capsulotomy on the visual axis.

CAPSULaser creates an elastic capsulotomy rim resistant to tearing with a rolled over edge (double thickness), a smooth amorphous collagen rim and a continuous 360° tag free profile. CAPSULaser is a small ergonomic device providing seamless integration into the cataract work flow with no requirement to move the patient as the capsulotomy takes place at the pre-existing OR microscope. CAPSULaser provides a cost and time effective solution to create the ideal capsulotomy with affordable acquisition and running costs, a short and straight forward learning curve and offering a non-invasive procedure with improved visualization throughout the surgery.

EXCEL-LENS, Inc. Chairman & CEO David Mordaunt reported; “I first conceived the idea for CAPSULaser back in 2007. The plan was to create a laser capsulotomy device that would provide both improved patient outcomes and surgeon benefits through its accuracy and simplicity. The journey from conception until today, where we now have approval to directly market in the second largest economic area in the world, has been an exciting journey. I am delighted to be able to announce the CE Marking of CAPSULaser so close to the 36th Congress of ESCRS in Vienna and look forward to meeting with many of the surgeons that have expressed such deep interest in this innovative technology”

Burkhard Dick, Professor of Ophthalmology and Chairman of The University Eye Hospital Bochum, Germany, stated “CAPSULaser has the great potential to completely replace manual capsulorhexis, the most crucial step in modern cataract surgery.“

Sheraz Daya, Chairman and Medical Director of Centre for Sight, East Grinstead, UK added “CAPSULaser I believe will be a very welcome addition to the armamentarium of cataract surgery.  With its ease and rapidity of use along with increased capsular edge strength, the device will make cataract surgery faster, reproducible and safer.  I can see the device potentially on every operating microscope in the future.”

Mr Richard Packard, Arnott Eye Associates, London, UK said; “I was delighted to hear the news that the selective laser device for capsulotomy, CAPSULaser, had received CE mark. This device that has been shown to provide better centred, more accurately sized and circular anterior capsulotomies should help to improve outcomes for cataract and refractive lens exchange surgery. We already know that symmetrical IOL optic coverage reduces posterior capsular opacification. A new generation of IOLs utilising the anterior capsule for fixation may enhance our refractive prediction as well as improving centration of the IOL on the visual axis so important in premium lens implantation.”

Dr Pavel Stodulka, Chief Executive Officer of the Gemini Eye Clinic, Czech Republic was the lead surgeon for the CAPSULaser CE study and was the first to use it clinically. He stated “CAPSULaser is a one of the greatest innovations in cataract surgery in the last 10 years. The surgical step performed by CAPSULaser takes only a second and adds  precision and safety to cataract surgery.“

Free Papers • Capsular Management • Sunday 23rd September • 16.30 – 18.00 • Room 4

Comparison of elasticity and fracture strength of manual, femtosecond laser, and selective laser capsulotomies (SLC)

Session Date/Time: Sunday 23/09/2018 | 16:30-18:00

Paper Time: 16:42

Venue: Room A4

Mr Sheraz Daya will present results from a 60 cadaver eye study.

Results:

Capsulotomies were performed in 60 cadaver eyes of 30 donors comparing CCC, Victus Femtosecond Laser, (Bausch & Lomb, Rochester, NY) or CAPSULaser, (Excel-Lens, Los Gatos, CA). The pairwise study demonstrates that the SLC fracture strength is superior to that of CCC by a factor of 1.5-fold with SLC 280 + 30 mN vs. CCC with 180 + 35 mN. Furthermore, CCC fracture strength was superior to that of FLACS by a factor of 1.4-fold with CCC 190 + 35 mN vs. FLACS 140 + 20 mN (P < 0.001 as determined by statistical analysis utilizing the Wilcoxon matched-pairs signed-ranks test and in accordance with the CONSORT guidelines). The SLC capsule edge on SEM demonstrated a rolled over edge anteriorly and alteration of collagen.

Conclusions:

The strength of the capsulotomy edge for SLC was significantly stronger than that of CCC which in turn was greater than FLACS. The relative strengths can be explained by review of SEM of each type of capsulotomy.

 

Clinical investigation of a new laser device to assess its efficacy and safety for the creation of anterior capsulotomies in cataract patients

Session Date/Time: Sunday 23/09/2018 | 16:30-18:00

Paper Time: 16:48

Venue: Room A4

Mr Richard Packard will present results from a 125 patient study.

Results:

For the 63 eyes in the selective laser capsulotomy group, all treated eyes had 100% free-floating capsulotomies. The mean diameter,, circularity and centration precision of the resultant capsulotomies for the laser group were determined to be superior to the manual group with a statistical p-value < 0.05. In the laser group 86% within 0.1mm of 5.0mm. For the manual group, 44% within 0.1mm (p-value ≤0.0001). There were no capsulotomy or cataract surgery related serious adverse events.

Conclusions:

A specially formulated trypan blue was safe and efficacious for staining the anterior capsule and for use with this new continuous laser. The laser was safe and efficacious when used with an intraocular dye for the creation of anterior capsulotomies during cataract surgery with greater sizing and circularity accuracy than can be achieved manually.

 

ESCRS Vienna – Friday 21st September – 17.30 -19.30

Exclusive Evening with the CAPSULaser Pioneers

Preparations for an exclusive CAPSULaser evening event at ESCRS are well under way. World renowned ophthalmologists, Richard Packard, Pavel Stodulka, Burkhard Dick, Sheraz Daya & Erik Mertens will present on clinical rationale and early experience with CAPSULaser. The event will be held at the prestigious “Palais Hansen Kempinski” which is very centrally located in Vienna on Friday 21st September from 17.30 to 19.30.

The event is strictly by invitation only, so please register your interest at info@capsulaser.com

CAPSULVisc™ & CAPSULGel™ receive CE certification

Breaking News – EXCEL-LENS receives CE Mark for CAPSULVisc 2% Sodium Hyaluronate, CAPSULVisc 3% Sodium Hyaluronate & CAPSULGel Optical Coupling Gel.

CAPSULVisc 2% sodium hyaluronate has been formulated to provide the ideal cohesive OVD for modern cataract surgery as well as the perfect partner for use with the CAPSULaser system (awaiting CE mark approval)

CAPSULVisc 3% sodium hyaluronate provides enhanced endothelial protection through its dispersive structure and is also formulated for use with the CAPSULaser system (awaiting CE mark approval)

Clearly Better…

·          Deep Anterior Chamber through exceptional cohesivity

·          Outstanding optical clarity for use with CAPSULaser

Optimized  Molecular Structure

·          Stays in place when you need it – protects the endothelium during phaco

·          Ease of removal during I/A

Quality & Peace of Mind

·          Non-immunogenic or pyrogenic

·          Double sterilized

·          Latex free

Convenience

·          No need for refrigeration

·          Large 1.1 ml syringe format for all stages of the cataract procedure

·          Ease of injection – high pseudoplasticity

CAPSULGel 2% Hydroxypropylmethylcellulose (HPMC) is formulated as a coupling gel to act as an optical zone between the cornea and the patient interface lens used with the CAPSULaser system (awaiting CE mark approval)

Clarity

·          Highly purified & exceptionally transparent HPMC

Protection

·          Coats and protects the corneal epithelium during all phases of cataract surgery

Quality & Peace of Mind

·          Non-immunogenic or pyrogenic

·          Double sterilized

·          Latex free

Convenience

·          No need for refrigeration

·          Large 1.1 ml syringe format for all stages of the cataract procedure

AECOS

Latest CAPSULaser clinical data presented at AECOS

Latest clinical data for CAPSULaser was shared by Mr Richard Packard during AECOS on Saturday 2nd June.

Mr Packard’s Presentation highlights:

  • 125 patient, prospective, controlled randomized clinical trial for CAPSULaser vs Manual capsulotomies
  • Safety, Efficacy & Accuracy demonstrated for CAPSULaser
  • 86% of capsulotomy diameter within 0.1mm of target vs 44% in the Manual group (p<0.0001)
  • CAPSULaser circularity superior to the manual group (p<0.0001)
  • CAPSULaser centration superior to the manual group (p<0.0001)
  • Accuracy Counts – 100% of patients in the CAPSULaser group have complete 360-degree IOL capsulotomy coverage vs 91% of the Manual group
  • CAPSULaser time & workflow similar to CCC
  • 100% Free floating capsulotomies for CAPSULaser

CAPSULaser 100% IOL coverage

Manual IOL coverage

 

Cataract & Refractive Surgery

ASCRS Washington

CAPSULASER showcased in the “Exciting New Devices That Will Help You” educational event moderated by Robert H. Osher, MD during ASCRS Washington April 13 – 17

Mr Richard Packard, MD, DO, FRCS, FRCOphth had a busy ASCRS for CAPSULaser, firstly presenting impressive sizing, circularity and centration data for CAPSULaser in the Industry Spotlight Theatre. Mr Packard then presented during the main program on the 16 April sharing details of the clinical investigation of CAPSULaser with emphasis on the efficacy & safety profile of this selective laser capsulotomy device. For more information please register your interest on the “contact” page of this website.

CAPSULBlue from CAPSULaser

CAPSULBlue™ receives CE certification

(Intraocular dye for cataract surgery)

CAPSULBlue™ intraocular dye has been specifically formulated for anterior segment surgery where better visualization of the anterior capsule is required. The optimum concentration, low volume (0.15ml) delivery has been manufactured to the highest levels of filtration and purification to provide a highly efficient but localized stain of the capsule.

CAPSULBlue™ provides enhanced performance when it comes to staining the anterior capsule in preparation for capsulotomy.

CAPSULBlue™ has been formulated to provide the ideal partner for the CAPSULaser Selective Laser Capsulotomy (SLC) system.

CAPULaser

Review of Ophthalmology

“Making the Cut: Capsulotomy Devices  – Achieving a strong, centered, perfectly circular capsulotomy may soon become simpler and easier”, writes Kristine Brennan in the Review of Opthalmology.

To read full article click on the link below:

https://www.reviewofophthalmology.com/article/making-the-cut-capsulotomy-devices

Best Innovations Video Award

Best “Innovations” Video Award for CAPSULASER

Pavel Stodulka wins the Best “Innovations” Video Award for CAPSULASER at ESCRS Copenhagen.

To view video on YouTube click on the link below:

www.youtube.com/watch?v=tpmc5pbWBOc

Pavel Stodulka interviewed in EuroTimes

Capsulotomy Laser – EuroTimes

“We have tried to approach the capsulotomy from a different angle,” said Pavel Stodulka MD, PhD, of the Gemini Eye Clinics in the Czech Republic. He presented his experience with the CAPSULaser laser during an interactive free paper session on femto laser-assisted cataract surgery at the XXXIII Congress of the ESCRS in Barcelona, Spain, writes Leigh Spielberg in the EuroTimes. To read full article click on the link below:

http://www.eurotimes.org/capsulotomy-laser/

Richard Packard of CRSTEurope

Video Journal of Cataract & Refractive Surgery

Video Journal of Cataract & Refractive Surgery – Towards the Perfect Capsulotomy – The 2015 Binkhorst Lecture by By Richard Packard, MD, FRCS, FRCOphth

Over the course of 265 years, the capsulotomy has evolved from a crude opening to give access to the nucleus for its removal to a continuous curvilinear capsulorrhexis for both anterior and posterior capsules to contain the IOL, writes Richard Packard from CRSTEurope.

To read full article click on the link below:

https://crstodayeurope.com/articles/2015-oct/the-evolution-of-the-capsulotomy/

Cataract & Refractive Surgery

A New Approach to Laser Capsulotomy

Creation of consistently sized, centrally located, circular capsulotomies has long been the goal of the cataract surgeon, writes Richard Packard. To read full article on CRSTEurope click on link below:

https://crstodayeurope.com/articles/2015-oct/a-new-approach-to-laser-capsulotomy/