New Trifocal IOL Delivers Positive Outcomes

Initial clinical results of a new trifocal IOL (Triva-aXAY, HumanOptics) with a novel diffractive design and a large optic have demonstrated excellent performance in terms of visual acuity and delivering high levels of patient satisfaction, according to Pavel Stodůlka MD, PhD.

“This lens has an innovative and very smooth implantation technique and delivers excellent monocular and binocular visual acuities at all distances,” he said. “Notably, over one-third of patients reported no dysphotopsia at all, while low numbers of patients reported strong halo and glare effects, which is an impressive performance for a trifocal lens.”

Dr Stodůlka said matching the appropriate IOL to the right patient profile is the key to success.

“It is now more than 75 years since the first IOL was implanted, and it is good to see the pace of innovation continues today,” he said. “The properties of this trifocal lens may offer the anticipated level of vision quality sought by individuals with high expectations and a desire for freedom from spectacles.”

Discussing the properties of the Triva-aXAY, Dr Stodůlka explained it is a hydrophilic acrylic lens with a 7.0 mm large optic, seven diffractive rings, near additions of +1.75 D and +3.50 D, and a 3.5 mm diffractive zone. The lens offers built-in powers ranging from +10.00 to +30.00 D in 0.50 D increments.

“The optic is designed to minimize dysphotopsia, even in larger pupils, and, with only 7 diffractive rings, achieves similar or even better results than traditional trifocal with up to 26 diffractive rings,” he said. “Because the IOL was bigger than other designs, we had some difficulties with implantation with the first models—but our new proprietary implantation technology has resolved this issue and made it very easy and smooth to deliver the lens into the capsular bag.”

One of the novelties of this lens is the plate cut-out haptics are folded underneath the optic at the moment of delivery into the capsular bag.

“We enter with the cartridge inside the eye at the level of the capsulorhexis, and when the optic leaves the cartridge tip, the whole lens unfolds easily in the capsular bag. It is super easy,” Dr Stodůlka explained. “Then we aspirate the viscoelastic and clean up the eye, and we end up with a well-centred large optic with a much lower risk of dysphotopsia coming from the edge.”

Dr Stodůlka’s study included 32 eyes of 16 patients with a median age of 58 years implanted with Triva-aXAY as part of routine cataract surgery. Median IOL power was 23.50 D, and follow-up was set at six months.

“In terms of results, we got what we expected, and the patients were happy,” he noted. “All eyes had corrected distance visual acuity (CDVA) of 0.1 logMAR or better, and 0.2 logMAR or better was achieved in 78% of eyes for distance corrected intermediate vision acuity (DCIVA) at 80 cm and 97% of eyes for distance corrected near visual acuity (DCNVA) at 40 cm.”

The binocular corrected visual acuity outcomes were also satisfactory, with all patients achieving 0.3 logMAR or better at all distances. The spherical equivalent refractive accuracy showed a slightly myopic outcome with 53% of eyes from -0.14 D to -1.00 D and 75% of eyes within ±0.50 D of target refraction.

“That is a very nice outcome for an initial series,” Dr Stodůlka said.

Regarding dysphotopsia, halo was reported as ‘no or mild’ in 79%, glare as ‘no or mild’ in 64%, starburst in 64%, and 36% of patients reported no photic phenomena at all.

“For a diffractive full range of vision IOL, these are very nice results indeed,” he concluded.

Dr Stodůlka presented at the 2024 ESCRS Winter Meeting in Frankfurt.

Pavel Stodůlka MD, PhD, FEBOS-CR is founder, chief surgeon, and CEO of Gemini Eye Clinics in the Czech Republic and Vienna, Austria. stodulka@lasik.cz