Cataract: Does surgery with the femtosecond laser offer advantages over other procedures for people affected? [Internet]

Excerpt

Research question of the HTA report: The aims of this investigation are to

1. assess the benefit of femtosecond laser-assisted cataract surgery compared to standard cataract surgery in adults with diagnosed cataracts with regard to patient-relevant outcomes,

2. determine costs (intervention costs),

3. assess cost effectiveness as well as

4. review ethical, social, legal, and organizational aspects associated with femtosecond laser-assisted cataract surgery.

Conclusion of the HTA report: The benefit assessment identified 36 randomized controlled trials comparing femtosecond laser-assisted cataract surgery versus standard manual cataract surgery, of which 35 studies provided results for the benefit assessment. A total of 7189 eyes of 5510 patients were treated with one of the two surgical techniques in these studies. The mean age of the participants was 57 to 73 years, and the majority had age-related cataracts.

All commercially available laser systems (VICTUS Femtosecond Laser Platform, CATALYS Precision Laser System, LenSx Laser System, LENSAR Laser System, Ziemer FEMTO LDV 8) were investigated in the randomized controlled trials, with the LenSx Laser System from Alcon being the most frequently investigated system. In the randomized controlled trials, the outcomes mainly analysed were visual acuity, refractive accuracy, and intraoperative or postoperative complications. The study duration was mostly between 1 and 18 months. Four randomized controlled trials only reported results obtained immediately after the procedure.

Overall, the randomized controlled trials included show that cataract surgery is safe and effective regardless of the surgical method chosen. Both in the intervention groups with femtosecond laser-assisted cataract surgery and in the control groups with standard manual cataract surgery, few intraoperative and postoperative complications occurred during the course of the study. Both the measured values of visual acuity (sharpness of vision) and those of refraction are almost within the normal range with both surgical techniques after a follow-up period of 1 to a maximum of 12 months.

The results of the individual randomized controlled trials comparing femtosecond laser-assisted cataract surgery versus standard cataract surgery are very homogeneous. Overall, the metaanalyses carried out did not reveal any statistically significant differences between the two surgical techniques for the outcomes of visual acuity, refractive accuracy, and intraoperative or postoperative complications. With regard to vision-related quality of life, there is also no difference between femtosecond laser-assisted cataract surgery and standard cataract surgery.

Thus, there is no hint, indication, or proof of an added benefit of femtosecond laser-assisted cataract surgery compared to standard manual cataract surgery for the investigated outcomes of visual acuity, refractive accuracy, and vision-related quality of life. At the same time, there is also no proof, indication, or hint of lesser or greater damage from femtosecond laser-assisted cataract surgery compared to standard manual cataract surgery.

The costs of both procedures for standard cataract surgery in Germany in an outpatient setting are around €900 to €1000, and for surgery using a femtosecond laser they are estimated to range from €700 to €2100. The 2 health economic evaluations conducted for the UK and French health care systems conclude that, from the payers’ perspective, the femtosecond laser procedure is unlikely to very unlikely to be cost-effective compared to the standard procedure. Considering the results of the benefit assessment of the present report and given the difference in intervention costs, a similar result can be assumed for Germany.

Although the benefit assessment shows neither an added benefit nor a reduced potential for harm of femtosecond laser-assisted cataract surgery compared to the standard procedure, it is sometimes advertised as more precise or safer. Objective counselling and information in this regard by the attending physicians are therefore of great importance for the informed decision-making of those affected, especially in view of the fact that patients who opt for femtosecond laser-assisted cataract surgery have to bear at least part of the costs themselves. The legal uncertainty regarding the billable procedure codes in this context has been clarified by a ruling of the German Federal Court of Justice, according to which only charging the lower-priced laser surcharge is permissible if there is no independent medical indication. Public investment in the more expensive femtosecond laser-assisted cataract surgery is not in line with the principle of distributive justice given the lack of added benefit. In addition, the increased use of environmentally harmful consumables in femtosecond laser-assisted cataract surgery must be viewed critically, irrespective of the cost coverage. Since femtosecond laser-assisted cataract surgery is not an option for people with certain medical conditions or anatomical characteristics, it would have to be ensured that, even if femtosecond laser-assisted cataract surgery were to be used more and more, the medical skills required for the standard procedure (e.g. manual capsulotomy) would continue to be available to a sufficient extent to guarantee the care of these individuals.