NIDEK

NIDEK’S QUEST: The New EC-5000 EXCIMER Laser Platform

James Lewis · July 1, 2016 ·

BY JAMES S. LEWIS, MD

JULY 2016 | INSERT TO CATARACT & REFRACTIVE SURGERY TODAY

WHY DID YOU CHOOSE NIDEK FOR YOUR EXCIMER LASER UPDATE?

The Quest EC-5000 is the latest incarnation of NIDEK’s work-horse line of excimer lasers. NIDEK remains the only manufacturer to remain click-fee free. During the past 17 years, high-volume surgeons and value-based practices have gravitated to NIDEK because there are no user fees, no patient interfaces, no key cards, and no usage charges of any kind.
Two years ago, I purchased the Quest system because NIDEK had leapfrogged the competition’s population optimized wavefront technology. Their device-specific customized aspheric treatment zone (CATz) is a next-generation ablation pattern that leverages peripheral corneal tissue to achieve a final prolate cornea shape free from spherical aberration. CATz “shot-files” are based on the patient’s refraction and topography. Waring and Dougherty,1 in the FDA-filings for this device, proved a statistically significant reduction in night driving complaints post-operatively when compared with the patient’s best corrected pre-operative state. These findings, combined with an industry leading percentage2 of uncorrected 20/15 results post-LASIK, establishes Quest and the CATz algorithm as a performance breakthrough in excimer ablation technology.

DOES NIDEK HAVE TOPOGRAPHICALLY-GUIDED ABLATION?

NIDEK’s CATz algorithm can regularize corneal topography over a broad range of refractive errors. For appropriate cases, CATz adds a distinct topography-guided segmental ablation to regularize the resultant corneal shape. This approach enlarges the effective optical zone and preserves a prolate corneal curvature. CATz technology allows the LASIK surgeon to produce best-in-class visual results for both standard refractive cases and patients with mild, non-pathologic irregular astigmatism. Furthermore, CATz can be used for highly aberrated eyes, including patients status-post keratoplasty. I have treated a variety of patients with untoward visual phenomenon resulting from significant corneal scarring, decentered ablations, small optical zones, central islands, and flap injury. I have also addressed irregular astigmatism from DLK, epithelial ingrowth, corneal infection, complicated cataract surgery, and excessive limbal relaxing incisions.

HOW DO THE SURGEON AND LASER INTERFACE?

NIDEK’s bundled Final Fit Program drives the Quest platform. Physicians use this Windows-based software to organize patients, consolidate clinical information, construct surgical strategies, simulate refractive results and assess outcomes. The technology enhances the creative process and empowers the LASIK surgeon.

DESCRIBE USE OF CATz WITH A TYPICAL CASE

A 28-year-old patient presented with mild irregular astigmatism (Figure 1) and a warning from another LASIK center that a 20/20 result may not be feasible. I constructed a surgical plan addressing sphere, cylindrical, and irregularity. Final Fit generated the topography guided ablation pattern (Figure 2). This patient gained a line of BSCVA.

Figure 1. The axial topography on the left shows subtle irregular astigmatism (A). The right image is a simulated axial topography following CATZ (B).

Figure 2. The map on the left shows the proposed tissue removal (A). The 3D mesh on the right shows how CATz plans to regularize the corneal topography (B).

DESCRIBE USE OF CATz IN MORE DIFFICULT CASES

A 56-year-old post-LASIK ectasia patient had uncomplicated penetrating keratoplasty in each eye. Acuity was limited in one eye by significant irregular astigmatism (Figure 3) and a reluctance to wear an RGP. PRK with mitomycin was performed using the CATz algorithm. The patient, whose topography is shown in Figure 3, enjoys 20/25 acuity with spectacles 1 year later.

Figure 3. The left topography shows significant irregular astigmatism following full thickness penetrating keratoplasty (A). On the right is the post-operative topography one year after CATz-driven PRK (B). Best corrected spectacle improved from 20/40- to 20/25.

A 55-year-old, who had LASIK in 1999, tolerated limited spectacle acuity, glare, halos, starbursts, and driving difficulties for over a decade. The preoperative topography shown in Figure 4 explains these complaints. I performed topographically guided surgery and consequently enlarged the effective optical zone. The patient recovered 20/20 spectacle acuity and experienced a significant reduction in glare, halos, starbursts, and night driving issues. I have successfully treated several of my original LASIK patients who tolerated residual visual phenomenon from early generation excimer technology. Quest allows the LASIK surgeon to address an entire class of patient who, until now, have been underserved.

Figure 4. A moderately decentered ablation pattern from LASIK fifteen years ago is shown on the left (A). Topography after CATz shown on the right demonstrates an enlarged optical zone (B). BSCVA acuity improved from 20/40 to 20/20.

A distraught 29-year-old patient presented following complicated femtosecond flap creation and subsequent LASIK elsewhere. The novice surgeon had ablated tissue from both the stromal bed and the posterior flap. The resulting topography, shown in Figure 5, shows a 9.0 D astigmatic gradient across the visual axis. Two rounds of topo-guided surface ablation improved the topography which can be seen in the adjacent image.
Because correction of this patient required a segmental ablation of 20 microns (Figure 6), surgery was divided into two sessions 9 months apart. This patient gained a line of vision and now successfully wears contact lenses.

Figure 5. The left image shows a highly aberrated cornea following complicated LASIK (A). Two courses of CATz-driven PRK resulted in the improved topography shown on the right (B). The patient gained a line of BSCVA and can now tolerated a contact lens.

Figure 6. NIDEK’s Final Fit Software shows the theoretical ablation map needed to regularize the astigmatism in this challenging case (A). The image on the right demonstrates the tissue elevation addressed in 3D (B).

SUMMARIZE YOUR EXPERIENCE WITH THIS NEW PLATFORM

NIDEK’s Quest introduces CATz and Final Fit to the refractive surgeon. CATz maintains a prolate cornea and reduces spherical aberrations. When indicated, its segmental ablation pattern can extend these outstanding visual results to patients with modest irregularities in corneal astigmatism. Final Fit enables the surgeon to design the ideal procedure for every clinical scenario. In my opinion, Quest has expanded and energized LASIK.

1. Waring G, Dougherty PJ, Chayet A, et al. Topographically guided LASIK for myopia using the Nidek CXII Customized Aspheric Treatment Zone (CATz). Trans Am Ophthalmol Soc. 2007;105: 240-248.
2. Blanton CL. Meta-analysis of six excimer laser platforms for safety and efficacy in myopic laser-assisted in situ Keratomileusis. US Ophthalmic Review. 2015;8(1):23-29.

James Lewis, MD, is a tertiary care anterior segment specialist who has practiced in Elkins Park, Pa., for 27 years. He purchased his first NIDEK in 1999 and has always had an interest in treating highly aberrated corneas with the excimer laser. Dr. Lewis reports no relevant financial disclosures.
He may be reached at jslewis@jameslewismd.com

Case studies described in the article were performed solely at the physician’s discretion without any endorsement from NIDEK.

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Fixing a Decentered Ablation

James Lewis · April 14, 2016 ·

April 2016

By James S. Lewis, MD; Charles R. Moore, MD; Asim Piracha, MD; and William F. Wiley, MD

Case Presentation

A 30-year-old man is referred to you. Prior to LASIK, his manifest refraction was -7.50 +1.25 × 174 = 20/20 OD and -7.25 +0.75 × 19 = 20/20 OS (Figure 1).

Figure 1. Preoperative measurements with the Orbscan (A) and the OPD-Scan III (B).

The original wavefront-guided ablation was performed with the Visx Star S4 (Abbott Medical Optics) after flap creation with a femtosecond laser. According to the surgeon, the procedure was without incident, with good fixation and functioning eye tracking. The patient reports that the vision in both eyes improved after surgery, but he complains of “fuzzy” vision in his right eye that is not correctable with manifest refraction.

Figure 2. Orbscan measurements taken 9 days after LASIK.

Upon examination, the patient’s current UCVA measures 20/70 OD and 20/25 OS. His manifest refraction is -2.75 +2.25 × 90 = 20/25 OD and +0.25 +0.50 × 106 = 20/20 (Figures 2-6).

Figure 3. Measurements taken with the Pentacam Comprehensive Eye Scanner approximately 5 months postoperatively.

Figure 4. Measurements taken with the iTrace (Tracey Technologies) approximately 5 months postoperatively.

What is the potential etiology of this patient’s problem? What is his prognosis? How would you proceed?

—Case prepared by William F. Wiley, MD.

Fig_5_visx_plan_4

Figure 5. Advanced CustomVue treatment plan guided by the WaveScan WaveFront System (both from Abbott Medical Optics). Note the total ablation of 32.4 μm.

Fig_6_topo_plan_4

Figure 6. CATz (Custom Aspheric Treatment Zone; Nidek) plan processed by Final Fit, based on OPD-Scan III topography. Note the ablation for irregularity in the bottom right corner planning for 12.3 μm of irregular ablation (with a total of 56.7 μm of ablation).

JAMES S. LEWIS, MD

This patient with high myopia had normal corneal pachymetry readings, regular topography (average keratometry readings of 41.00 D OU), and no relevant ocular, family, or social history. Despite both eyes’ perfect appearance at the slit lamp postoperatively, he described the vision in his right eye as blurry. One week postoperatively, the manifest refraction was -2.75 +2.25 X 90 OD with a BCVA of 20/25- versus near plano and 20/20 OS. Orbscan topography (Bausch + Lomb) suggests a 3-mm superiorly decentered ablation. The corneal morphology rules out inadvertent ablation of the flap’s posterior surface, which can occur in such cases.

My recommendation is to use the irregularity ablation pattern shown in Figure 6. Nidek’s Final Fit Software can address these challenging cases with topography-guided treatment. The simulated axial map shows a predicted enlargement of the central optical zone. My preference would be to lift the flap and treat only the 12.3-µm irregularity component at this stage (off label). I caution patients that a second and sometimes a third retreatment may be needed. Fortunately, this patient has plenty of residual stroma, a normal flap, and a healthy left eye.

I have treated more than a dozen patients with this degree of irregularity and many more with higher degrees of topographic abnormality. The results have been encouraging.

CHARLES R. MOORE, MD

The preoperative measurements with the Orbscan and OPD-Scan III (Nidek) appear to be normal and show myopic astigmatism. The problem is a result of a decentered ablation superiorly and possible ablation inside the superior edge of the flap. This produced irregular cylinder, coma, and poor-quality vision. My suggestion would be to refer this patient for topography-guided PRK (or a LASIK relift) to someone with a lot of expertise in treating this type of complication. An alternative would be to consider Intacs (Addition Technology), but in my experience with this sort of problem, topography-guided results are superior. This case is a classic example of why patient fixation is necessary even with an eye tracker.

ASIM PIRACHA, MD

Figure 1A shows regular astigmatism and sufficient central corneal thickness for the treatment of his refractive error. He lost 1 line of BCVA after LASIK.

The postoperative measurements, visual acuity, and refraction are consistent with a decentered ablation that, although rare, can still occur with modern excimer laser systems. The patient has a residual compound myopic astigmatic refractive error and increased irregular corneal astigmatism. The surgical procedure was noted to be routine without flap-related complications, a decentered or small-diameter flap, or poor fixation.

To further evaluate this patient, I would perform an overrefraction with a rigid gas permeable lens and testing with the iTrace to confirm that the loss of BCVA is due to the irregular astigmatism or decentered ablation. If the patient’s BCVA improved with the overrefraction and the iTrace showed low internal aberrations, then either a wavefront-guided or a topography-guided ablation could be considered. I would confirm that the manifest refraction and topography were stable before proceeding with further treatment.

In this case, my preference would be topography-guided surface ablation to conserve tissue, treat corneal aberrations on the cornea, expand the optical zone, and center the treatment over the corneal apex rather than the pupil. Because it can only flatten the cornea and does not combine hyperopic and myopic ablations to correct the higher-order aberrations, wavefront-guided treatment would further flatten an already flat cornea and remove a greater amount of tissue from a thinned cornea.

The only topography-guided treatments available in the United States use the Allegretto Wave Eye-Q (Alcon) and Nidek EC-5000 CXII (Nidek) lasers. These treatments are approved for LASIK on normal corneas, however, not for irregular postsurgical astigmatism. Thus, topography-guided ablation would be an off-label use of the laser in this case. The patient should be fully informed and understand prior to treatment that the primary purpose of surgery is to improve his BCVA and not necessarily his UCVA. He should also understand that a second surface ablation procedure might be needed to correct any residual refractive error.

WHAT I DID: WILLIAM F. WILEY, MD

The patient was referred to me for confirmation of the diagnosis of a decentered ablation and treatment recommendations. Based on the postoperative topography, I confirmed the diagnosis. Analysis for wavefront- and topography-guided ablation approaches was performed to help me determine the most appropriate treatment recommendation (Figures 5 and 6). The Final Fit software (Nidek) displays the irregular portion of the proposed ablation pattern prior to surgery. This allowed me to compare the proposed irregular treatment with the corneal topography to determine if the ablation pattern matched the corneal irregularity. Furthermore, with topography-guided ablation, I can see the anticipated postoperative topographic appearance prior to surgery to ascertain if it will be an improvement over the pre-enhancement topography.

In this case, the anticipated topography showed potential improvement (Figure 6), and the irregularity treatment pattern correlated with the elevation maps shown on the Pentacam Comprehensive Eye Scanner (Oculus Surgical; Figure 3). Topography-guided LASIK has been reported to yield an improvement in irregular astigmatism,1 which I discussed with the patient along with the potential need for multiple surgeries to achieve a satisfactory outcome.

The patient chose to proceed with an enhancement. I lifted the flap and performed topography-guided ablation. On postoperative day 1, the patient had a UCVA of 20/20, and his symptoms had improved. I await further follow-up and postoperative topography results. n

1. Gatinel D, Bains HS. Treatment of highly aberrated eyes using the Nidek CXIII excimer laser. J Refract Surg. 2010;26(6):453-457.

Section Editor Alan N. Carlson, MD
• professor of ophthalmology and chief, corneal and refractive surgery, Duke University Eye Center, Durham, North Carolina

Section Editor Stephen Coleman, MD
• director of Coleman Vision, Albuquerque, New Mexico

Section Editor Karl G. Stonecipher, MD
• clinical associate professor of ophthalmology, University of North Carolina, Chapel Hill
• director of refractive surgery, TLC in Greensboro, North Carolina

Section Editor William F. Wiley, MD
• private practice at Cleveland Eye Clinic, Cleveland, Ohio
• (440) 526-1974
• financial disclosure: consultant to Abbott Medical Optics and Alcon

James S. Lewis, MD
• private practice, Elkins Park, Pennsylvania
• (215) 886-9090; jslewis@jameslewismd.com
• financial interest: none acknowledged

Charles R. Moore, MD
• medical director, International EyeCare Laser Center, Houston
• (713) 984-9777; crm@texaslasik.com
• financial interest: none acknowledged

Asim Piracha, MD
• medical director, Cornea, Cataract and Refractive Surgery Service, John-Kenyon Eye Center, Louisville, Kentucky
• associate professor, Department of Ophthalmology and Visual Sciences, University of Louisville, Louisville, Kentucky
• (502) 895-2910; apiracha@johnkenyon.com
• financial disclosure: member of the speakers’ bureau for Abbott Medical Optics

The Experts Agree – NIDEK

James Lewis · March 24, 2015 ·

Technically Speaking… The Experts Agree. There’s a lot to like with NIDEK.

[su_quote]Over 90% of the time we are getting excellent quality photo images which enable us to show optic nerve defects directly to patients. It’s like an epiphany when patients can see for themselves. This cuts down on second opinions. The quality transforms the whole patient conversation.[/su_quote]
– Dr. Thomas Jennings, Key-Whitman Eye Center, Dallas, Texas

[su_quote]The RS-3000 provides outstanding anatomic detail, superb ergonomics and enhanced office efficiency. I can visualize vital structures in the cornea, angle, choroid and retina with minimal effort. Because the software is well designed, I can show patients their images from the pravacy of the exam room… even when the RS-3000 is being used by another practitioner. No other device has this functionality. It is a breath of fresh air.
[/su_quote]
– Dr. James S. Lewis, Elkins Park, Pennsylvania

[su_quote]The NIDEK RS-3000 Advance OCT unit makes for increased efficiency when it comes to doing

. Patients are easily positioned for an OCT scan and technicians are able to quickly perform the scan with minimal instruction to the patient during the scan. The results of the scan are immediately available for viewing in the exam room by the physician and the patient on any available workstation. The software for analyzing the scan is easy to use and the images are clear and easy to present to the patient. The RS=3000 is a winner for physicians, technicians, and most importantly , the patients. [/su_quote]
– Dr. Darrel Genstler, Genstler Eye Center, Albany, Oregon

Advanced LASIK Surgical Suite

d p · May 9, 2014 ·

Most Advanced LASIK Surgical Suite

Every Wednesday we broadcast live LASIK from our state-of-the-art surgical Suite.
Moria OUP and NIDEK Topography-Guided Excimer Laser are here at LewisLASIK to provide our patients with the safest, most comfortable, and most capable lasers available, anywhere!

Eye News Volume II Issue 12

d p · May 6, 2001 ·

Philadelphia / Bucks County LASIK Surgeon – Dr. James S. Lewis

Eye News Volume II Issue 12

Dr. James Lewis evaluates the latest LASIK technology

Nidek announces a Confocal Microscope. Dr. Lewis, Medical Director of iHateMyClasses.com views the finest details of a patient’s cornea.

ASCRS attracts International Surgeons

While ASCRS stands for the American Society of Cataract and Refractive Surgeons few use that name. One reason is the attendance by European, Asian, Australian, and South American Ophthalmologists nearly matches the American contingent.
The quality of the lectures, courses, exhibits, and films explain some of the popularity of this meeting.
“I haven’t missed an ASCRS meeting in a decade,” claims James Lewis, MD. “The hardest thing about this meeting is to spend your time wisely. There are courses and scientific papers from 7:30 AM until 6:00 PM.”
Every year the Innovator Award is given to the Ophthalmologist who has done the most for refractive surgery. This year Gholam Peyman, MD the inventor (and patent holder) of modern LASIK was recognized. Dr. Peyman, surprisingly, is a University retinal surgeon, and does not even perform the surgery!
Dr. Peyman, who has written hundred of books and thousands of articles, is a very quiet and modest man. In the photo to the right Manus Kraff, MD, another pioneer in cataract surgery, prepares to present a trophy for Dr. Peyman’s achievements.
Another lecturer at this very special session was Charles Kelman, MD. Dr. Kelman invented almost every major technique for cataract removal during the last 30 years. Despite terminal cancer, he is working with manufacturers to help patients with small lung tumors before they have metastasized. Expectedly, he was given an overwhelming standing ovation.
“When you see giants like this, it makes you proud to be an Ophthalmologist,” Lewis added.
Another highlight of this meeting was the ASCRS Film Festival. Over 300 short films on refractive surgical techniques are submitted for judging by a distinguished panel of surgeons. They are judged on originality, relevance, educational merit, and production value. Dr. Lewis still displays his trophy from the 1993 ASCRS meeting when he won second place.

Hundred of Exhibitors display their products to Ophthalmologists and their staff. Everyone wants to know what’s HOT.

Thousands of refractive surgeons from around the world attend this week’s ASCRS meeting.

Nidek introduces
device to monitor corneal health in LASIK patients

SAN DIEGO, California- Nidek Technologies has just released the Confoscan 2. This device allows the refractive surgeon to assess corneal thickness, post-LASIK flap thickness, and endothelial health.
As LASIK and other refractive surgeries become more popular the need to address more complex cases is growing. Enhancement surgery for those with an insufficient correction also requires a complete assessment of corneal anatomy.
“I anticipate a day when confocal microscopy becomes the standard of care for the LASIK surgeon. Clearly, it is vital in complex cases,” Lewis reports.
Residual corneal thickness is always a concern in LASIK. The confocal microscope has been used in research laboratories for years. Now that clinically viable devices exist patients will benefit.
Problems like keratoconus, endothelial dystrophy, and infection plague the active refractive surgeon. The confocal microscope will help optimize patient care.
Other companies like Ultralink LLC and others have identified the importance of this new technology. Look to EyeNews for further developments.

Over the years, Dr. James Lewis has established a reputation as a leading Philadelphia LASIK surgeon. In addition to LASIK, he performs Epi-LASIK in Philadelphia. This variation of LASIK does not involve the creation of the corneal flap, which is why it is suitable for many patients with thinner corneas. Dr. Lewis also has multiple years’ experience performing implantation of Visian ICLs. In fact, he was one of the first surgeons in Pennsylvania to implant Visian ICLs and is renowned as a leading Visian ICL Philadelphia specialist.