SMART TEC NANOTECHNOLOGY LASER

Transcription

1 SMART TEC NANOTECHNOLOGY LASER HEALTH TECHNOLOGY ASSESSMENT SECTION HEALTH TECHNOLOGY ASSESSMENT SECTION MEDICAL DEVELOPMENT DIVISION MINISTRY OF HEALTH MALAYSIA SERIAL NO 024 /2011 MEDICAL DEVELOPMENT DIVISION MINISTRY OF HEALTH MALAYSIA 1 024/2011

2 DISCLAIMER Technology review is a brief report, prepared on an urgent basis, which draw on restricted reviews from analysis of pertinent literature, on expert opinion and / or regulatory status where appropriate. It has not been externally reviewed. While effort has been made to do so, this document may not fully reflect all scientific research available. Additionally, other relevant scientific findings may have been reported since completion of this review. Please contact: htamalaysia@moh.gov.my, if you would like further information. Health Technology Assessment Section, Medical Development Division Ministry of Health Malaysia Level 4, Block E1, Precinct 1 Federal Government Administrative Centre Putrajaya Tel: Fax: Available at the following website: i

3 Prepared by: Ms. Sin Lian Thye Nursing Matron Health Technology Assessment Section Medical Development Division Ministry of Health Malaysia Reviewed by: Datin Dr. Rugayah Bakri Deputy Director Health Technology Assessment Section Medical Development Division Ministry of Health Malaysia DISCLOSURE The author of this report has no competing interest in this subject and the preparation of this report is totally funded by the Ministry of Health Malaysia. ii

4 EXECUTIVE SUMMARY Introduction Precise cut corneal flaps are essential for successful laser in situ keratomileusis (LASIK) treatments. Even with modern mechanical microkeratomes, variations in flap thickness and morphology can be found. Differences in flap thickness can be related to several factors, including the microkeratome model used. The manufacturers have made extensive improvements in their microkeratomes over the past years to create more precise flaps. However, many complications of LASIK surgery are still related to the flap-cutting process. The advantage in comparison to conventional mechanical microkeratomes is that common complications of LASIK surgery like button holes, free caps, or high variations in flap thickness can be avoided, and the shape of the flap can be individualized to the needs of the patient and surgeon. This review was to evaluate the Smart Tec Nanotechnology Laser upon the request from the Principal Assistant Director, of Surgical Services Unit, Medical Development Division. Objective/Aim To assess the safety, effectiveness and cost-effectiveness of Smart Tec Nanotechnology Laser but not on the excimer laser. Result and Conclusion There was no retrievable evidence on safety, effectiveness and cost-effectiveness of Smart Tech Nanotechnology Laser. Methods Electronic database which include MEDLINE In-Process & Other Non-Indexed Citations; The Cochrane Library including Cochrane Central Register of Controlled Trials and Cochrane Database of Systematic Reviews; Centre for Reviews and Dissemination including Health Technology Assessment Database through Ovid interface; Parallel searches were run in PubMed; Conference proceedings Citation Index (Web of Science); BIOSIS; Current Controlled Trials; Clinical trials.gov; CenterWatch; Horizon Scanning databases (Euroscan, National Horizon Scanning Centre, Australia and New Zealand Horizon Scanning Network), and FDA, MHRA website, as well as general search engine such as google, google scholar were search. The distributing company representative was inevitably contacted through our local ophthalmogist to provide any available scientific iii

5 SMART TECH NANOTHECHNOLOGY LASER 1. INTRODUCTION Precise cut corneal flaps are essential for successful laser in situ keratomileusis (LASIK) treatments. Even with modern mechanical microkeratomes, variations in flap thickness and morphology can be found. Differences in flap thickness can be related to several factors, including the microkeratome model used. The manufacturers have made extensive improvements in their microkeratomes over the past years to create more precise flaps. However, many complications of LASIK surgery are still related to the flap-cutting process. An alternative way of producing LASIK flaps involves modern lasers that are based on the femtosecond laser technology. At the moment, two femtosecond laser systems are commercially available on the market and are U.S. Food and Drug Administration (FDA) approved for the creation of LASIK flaps. One of these systems is the Femtec femtosecond laser system (20/10 Perfect Vision, Heidelberg,Germany). The wavelength of this laser is 1 µm infrared, and the spot size adjustable to several micrometers. By photodisruption of the corneal tissue with a non-thermal ablation process thus the stromal layers can be divided and a LASIK flap created. The laser-induced vaporized tissue forms a cavitation of gas bubbles that mainly consists of CO 2, N 2, and H 2 O. The gas bubbles diffuse out of the cornea through normal mechanisms. 1,2 The advantage in comparison to conventional mechanical microkeratomes is that common complications of LASIK surgery like button holes, free caps, or high variations in flap thickness can be avoided, and the shape of the flap can be individualized to the needs of the patient and surgeon. This review was to evaluate the Smart Tec Nanotechnology Laser upon the request from the Principal Assistant Director of Surgical Services Unit, Medical Development Division, Ministry of Health Malaysia. 2. OBJECTIVE/AIM To assess the safety, effectiveness and cost-effectiveness of Smart Tec Nanotechnology Laser but not on the excimer laser. 1

6 3. TECHNOLOGY FEATURE The SmartTech nanosecond laser system is based on nanosecond laser technology and uses the principle of plasma creation for separation of the corneal tissue. Instead of a highly complex technology of a femtosecond laser, (an innovative microchip laser), which operates with blue light in the ultra violet (UV) range (355 nm) and produce ultra-short light pulse. Each pulse was shorter than billionth of a second. When compared to femtosecond laser systems using identical pulse energies, the emitted peak power in Watts is lower by a factor of more than one thousand. Short UV laser light wavelengths make it possible to achieve a focus three times finer than that of the femtosecond laser's infrared pulse. This means that focus diameter and length of the SmartTech laser are just one third compared to standard femtosecond lasers. The result: while infrared lasers disrupt several layers of corneal lamellae, the UV microchip laser system precisely separates individual corneal lamella. This leads to exceptionally precise cuts and smooth cut surfaces as well as to a better predictability of flap thickness. The flap can be lifted just as easily as with the mechanical microkeratome. A further advantage: the microchip laser is considerably more compact, durable and robust than the femtosecond laser under usual operating conditions. It merely requires a normal power supply and works without elaborate cooling systems 3. 2

7 This SmartTech Laser is possible to combine with any standard excimer laser on the market, in which the excimer laser must be equipped with a swiveling bed. This system, which is now under development, the first application after the launch of the SmartTech Laser will concentrate on LASIK flap creation. 4. METHODS 4.1 Searching The following electronic databases were searched: MEDLINE In-Process & Other Non-Indexed Citations; The Cochrane Library including Cochrane Central Register of Controlled Trials and Cochrane Database of Systematic Reviews; Centre for Reviews and Dissemination including Health Technology Assessment Database through Ovid interface; Parallel searches were run in PubMed; Conference proceedings Citation Index (Web of Science); BIOSIS; Current Controlled Trials; Clinical trials.gov; CenterWatch; Horizon Scanning databases (Euroscan, 3

8 National Horizon Scanning Centre, Australia and New Zealand Horizon Scanning Network), and FDA, MHRA website, as well as general search engine such as google, google scholar were search. The following terms were used either singly or in various combination : nanosecond laser, SmartTech laser, SmartTech nanosecond laser, nanosecond laser assisted corneal surgery, corneal flap cutting. The distributing company was inevitably contacted through the local ophthalmologist to provide any available scientific evidence. However, its failed to provide evidence related to SmartTech nanosecond laser, but provided a numbers of article regarding the Schwind Amaris Excimer Laser in which is not under the purview of this review. 4.2 Selection All published article related to safety, effectiveness and cost - effectiveness of Smart Tec Nanotechnology Laser conducted in human were included. Retrieved articles were critically appraised and evidence was graded according to US/Canadian Preventive Service Task Force (Appendix 1). 5. RESULTS AND DISCUSSION There was no scientific evidence on safety, effectiveness and cost retrievable from the databases about this technology. The company claimed that the SmartTech Laser met all requirement of the Medical Device Directive (CE mark) regarding the safety feature. It was also stated that the first outcome study on human eyes are planned to be publish at the beginning of In term of cost, a personal communication with the local Ophthalmogist, she stated the price of this technology is about RM 4 million with 5 year guarantee. (personal communication 10/11/2011) There were technology reviews report on LASIK surgery been conducted by MaHTAs (Malaysian Health Technology Assessment Section). The reports were on Refractive surgery (LASIK) in May 2006 and Laser Assisted Corneal Ophthalmic Surgery (Femtosecond Laser) October The result showed that laser assisted ophthalmic surgery was safe and effective in the treatment of many pathological corneal conditions but it is more costly than conventional methods. 4

9 6. CONCLUSION There was no retrievable evidence on safety, effectiveness and cost-effectiveness of Smartech Nanosecond Laser. 5

10 REFERENCES 1. Stern D, Schoenlein RW, Puliafito CA, Dobi ET, Birngruber R. (1989). Fujimoto JG. Corneal ablation by nanosecond, picosecond, and femtosecond lasers at 532 and 625 nm. Arch Ophthalmol. 107: Juhasz T, Loesel FH, Kurtz RM, Horvath Ch, Bille JF, Mourou G. (1999). Corneal refractive surgery with femtosecond lasers. IEEE J Selec Top Quantum Elec. 5: Schwind eye tech solution News. retrieved on 30/10/ Schwind eye tech solution FAQ SmartTech Laser 6

11 APPENDIX 1 DESIGNATION OF LEVELS OF EVIDENCE I II -1 II-2 II-3 III Evidence obtained from at least one properly randomized controlled trial. Evidence obtained from well-designed controlled trials without randomization. Evidence obtained from well-designed cohort or case-control analytic studies, preferably from more than one centre or group. Evidence from multiple time series with or without intervention. Dramatic results in uncontrolled experiments (such as the results of the introduction of penicillin treatment in the 1940s) could also be regarded as this type of evidence. Opinion or respected authorities, based on clinical experience, descriptive studies and case reports; or reports of expert committees. SOURCE: US/CANADIAN PREVENTIVE SERVICES TASK FORCE (HARRIS 2001) 7