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FEMCAT study evaluating value of femtosecond cataract surgery
Early results showed significant improvements in visual acuity but a somewhat high complication rate.
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Almost 1,800 subjects have been enrolled in the French FEMCAT study evaluating the clinical value and cost-effectiveness of femtosecond laser-assisted cataract surgery, a speaker said at the European Society of Cataract and Refractive Surgeons meeting in Barcelona.
The study will be completed in the first half of 2016. It is designed to provide a scientific basis for the potential adoption of femtosecond laser-assisted cataract surgery in the French health care system, Béatrice Cochener, MD, PhD, OSN Europe Edition Board Member, said.
“Cataract surgery is one of the key issues for our medical care and for our ministries,” Cochener said. “We have this unique French model that may guide European strategy ... and we may apply this model to other countries. ... We hope to be eventually able to prove the better cost-utility ratio of femto over phaco in spite of the higher cost of the procedure and to produce an appropriate economical model. ... This is a big challenge for femto because the comparison is with a procedure that has proven so good that it is even comparable with hip surgery and superior to knee arthroplasty or defibrillator implantation in heart surgery.”
Study design
The FEMCAT study was designed by the late Joseph Colin, MD, in 2012 and was funded by the French Ministry of Health with 3.2 million. It is a prospective, randomized clinical trial comparing femtosecond laser-assisted cataract surgery with conventional phacoemulsification. It involves 20 surgeons at five university centers, or four surgeons at each center. Investigators hope to enroll a total of 2,000 patients.
The study comprises a 25-month inclusion period and a 12-month follow-up period.
“Each center must use the same phaco machine and procedures, but the phaco machine can be different between the centers. For the IOL, each center must use the same IOL, but the IOL can be different between centers,” Cochener said. “That means that we are dealing with a real-life study. There is standardization of the surgical procedure between both groups to analyze the effects of the femtosecond laser, but the analysis will be performed globally.”
Investigators want to focus on patients with true cataract, she said.
“That means people who are showing decreasing vision and all of the surgeons have been satisfied with the LOCS III,” Cochener said. “There are many exclusion criteria ... poor pupil dilation, clinically significant corneal scars or opacities, and history of amblyopia or complicated cataract surgery on the other eye.”
Investigators are assessing logMAR uncorrected and best corrected visual acuity, ocular biometry, topography, retinal nerve fiber layer thickness, macular thickness, corneal pachymetry, corneal incisions and IOL positioning with anterior segment OCT, endothelial cell counts, aberrometry and contrast sensitivity.
They also set out to estimate a cost-utility ratio and an appropriate economic model for femtosecond laser technology using quality adjusted life-years plus all medical and non-medical costs over a 1-year period.
An incremental cost-effectiveness ratio will focus on therapeutic success defined as no severe intraoperative or postoperative complications, best corrected visual acuity of 0 logMAR, refractive error inferior of 0.75 D or less, corneal surgically induced astigmatism inferior of 0.5 D or less, and a postoperative change of astigmatism axis of 20° or less.
Preliminary analysis
Cochener reported results of the pre-FEMCAT training study, a preliminary analysis of the first 10 cases performed by each surgeon, which underlined the key value of the learning curve. Data were available for 126 patients with no existing astigmatism and a mean age of 73.24 years.
Visual acuity results were good, and the complication rate was 16.7%, “oddly enough, more frequent with older and more experienced surgeons,” Cochener said. “If we take a look at visual acuity, we are doing great.”
Mean UCVA improved significantly, from 0.59 preoperatively to 0.14 at 1 month (P < .05). Mean BCVA improved from 0.28 preoperatively to 0.03 at 1 month (P < .05). Mean spherical equivalent improved from 2.15 D preoperatively to 0.52 D at 1 month (P < .05).
Refractive error was less than 0.25 D in 47.54% of cases, less than 0.5 D in 68.85%, less than 0.75 D in 81.97% and less than 1 D in 95.08%.
“[Despite] some imperfect incisions and non-comparison to phaco, the phaco appears to do better in terms of visual results when we compare it to the literature. Again, as you can see here, we are close to 50% of patients achieving [refractive error] within 0.25 D, which is better than the literature in phaco,” Cochener said.
Posterior capsule rupture occurred in 3.296% of cases, cornea edema in 3.296%, incomplete or leaking corneal incision in 9.5%, ocular hypertension in 0.896% and macular edema in 0%.
“What we can already assume is that the FEMCAT study will provide positive indications that further research is needed in specific subgroup populations to show its true patient and economic value,” Cochener said. – by Michela Cimberle and Matt Hasson
- For more information:
- Béatrice Cochener, MD, PhD, can be reached at Institut de Synergie des Sciences de la Santé – LATIM – CHRU Morvan Bât 2 bis – 5 avenue FOCH 29609 Brest Cedex, France; email: beatrice.cochener@ophtalmologie-chu29.fr.
Disclosure: Cochener reports no relevant financial disclosures.