Within the Work Package 4 of EUnetHTA Joint Action 3, femtosecond laser-assisted cataract surgery (FLACS) is currently under assessment by a team led by Emilia Romagna Region and supported by the Austrian agency Gesundheit Österreich (GÖG), the Belgian Health Care Knowledge Centre (KCE), and the Spanish agencies Basque Office for Health Technology Assessment (Osteba), Health Service of Canary Islands (SESCS), and Agency for Health Quality and Assessment of Catalonia (AQuAS).
The project plan has been released in February 2018 while the assessment report is expected within the end of October 2018.
The technology was proposed for assessment by Emilia Romagna Region following a request from local decision makers. FLACS is available in private centres but not yet widely introduced across public institutions and could have a heavy organisational and economic impact on services for patients needing cataract surgery.
The PICO structure has been defined as follows:
Adult patients (>18 years) of any gender, affected by cataract and for which the surgical treatment for cataract removal and insertion of intraocular lens could provide a gain in visual acuity and health-related quality of life.
Femtosecond laser-assisted cataract surgery (FLACS) to be used during the first phases of the intervention to create incisions, perform capsulorhexis, and fragment the lens. Conventional ultrasound phacoemulsification technique is used to complete the surgical procedure.
Standard cataract surgery.
Clinical effectiveness: Corrected Distance Visual Acuity (1 month; 6 months); Uncorrected Distance Visual Acuity (1 month; 6 months); Refractive outcomes; Vision-related quality of life as measured by any validated questionnaire; Patient Reported Outcomes.
Safety: Anterior capsular tear; Posterior capsular tear; Vitreous loss; Elevated intraocular pressure (1 day - 1 week); Endothelial cells loss; Central corneal thickness; Iridocyclitis; Cystoid macular oedema (within 90 days); Infections (within 90 days); Corneal endothelial decompensation (within 90 days); Surgically induced astigmatism; Retinal detachment; Posterior capsule opacification; Visual acuity loss post cataract surgery (1 month - 6months); Surgical re-intervention (within 6 months); Secondary cataract (24 months).
Other outcomes: Patient satisfaction; Procedural time; Resource use.
Selection of studies will be limited to randomised controlled trials (RCT) for clinical effectiveness outcomes while, for safety-related and other outcomes, non-randomised controlled studies will be considered as well if presenting follow-up over 6 months.
The following systems will be included in the assessment: LenSx Laser System (Alcon), Catalys Precision laser system (Abbott), Victus femtosecond laser platform (Bausch & Lomb), Lensar laser system (Lensar) and Femto LDV Z8 (Ziemer). The manufacturers have been involved during the preparation of the project plan and have been asked to provide a submission file for their systems. Before the publication, they will be asked to take part to the review of the assessment draft (expected for July 2018).
See the project plan in English here.
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