SMALLER INCISIONS

The new hydrophilic acrylic micro-incision Incise™ IOL™(Bausch + Lomb) provides very predictable refractive results, good visual acuity and a well centred positioning within the capsular bag, according to a series of presentations at the 18th ESCRS Winter Meeting in Ljubljana. “The lens can be implanted through an 1.8mm incision into the capsular bag, providing excellent visual and refractive outcomes,” said Antonio Toso MD, S Bassiano Hospital, Bassano del Grappa (VI), Italy.

He presented the preliminary results achieved with the Incise IOL in 25 eyes of 25 patients participating in a multicentre FDA trial. The patients in the study had a mean age of 72.0 years. All underwent sub-2.0 coaxial MICS using the Stellaris® (Bausch + Lomb) phacoemulsification system and implantation of an Incise IOL through an 1.8mm incision using the Viscoject 1.5™ IOL inserter.

Dr Toso noted that the Incise IOL is a one-piece lens composed of an enhanced hydrophilic material with 22 per cent water content. It has an aberration-free optic 6.0mm in diameter with a sharp posterior edge. Its overall length is 11.0mm. It has four fenestrated angulated haptics.

GOOD VISUAL OUTCOMES
After a follow-up period ranging from four to six months, uncorrected visual acuity ranged from 20/32 to 20/25 and had a mean value of 0.156 logMAR. In addition, mean corrected distance visual acuity was 20/20. Furthermore, the mean manifest refractive spherical equivalent was -0.28 with a standard deviation of zero, precisely equal to the target refraction.

Absolute total centration, that is, the distance of the centre of the optic from the centre of the pupil margin as measured by digital slit-lamp biomicroscopy, was 0.29mm. That is statistically comparable with the centration achieved with conventional one- or three-piece IOLs, which typically have a centration of 0.2mm to 0.6mm. He added that long-term results will be evaluated to assess the posterior capsule opacification.

PREDICTABLE LENS POSITION
Another study involving 26 eyes of 26 patients were implanted with Incise™ IOL, anterior segment OCT indicated that the postoperative effective lens position is very stable and predictable with the new lens, said Simonetta Morselli MD, also at S Bassiano Hospital. The mean postoperative distance of the optical plate from the cornea after the first month was 3.18mm and 3.13mm after the six months.

“The postoperative effective lens position is very predictable with Incise™ IOL. This means that the A constant was correctly calculated and the IOL stays stable in the capsular bag, avoiding postoperative refractive surprises,” she said.

BIAXIAL MICS 1.4MM INCISION
The results of yet another study indicated that the lens can be safely and effectively implanted into the eye through an even smaller, 1.4mm incision using biaxial MICS with even less trauma to the cornea than occurs with 1.5mm incisions, said Giulio Torlai MD, Institute of Ophthalmology, University of Modena & Reggio Emilia, Modena, Italy (head of the institute is Prof Gian Maria Cavallini).

The prospective study compared 30 eyes which underwent bi-axial-MICS and implantation of the INCISE MJ14 IOL through 1.4mm corneal incision with 30 eyes which underwent B-MICS and implantation of the Akreos MI60 IOL (Bausch + Lomb) through 1.5mm corneal incision, between April and July 2013. The same experienced surgeon (Prof G M Cavallini) performed all of the procedures, using the same technique for cataract extraction. The technique involved the creation of two trapezoidal clear corneal incisions at 10 and 2 o’clock, capsulorhexis is performed with a cystotome or with the dedicated microforceps, and phacoemulsification is performed with a 20-gauge, 30 degree-angled sleeveless probe and an irrigating chopper, by stop-and-chop technique.

The Akreos® MI60 IOL is the direct predecessor of the Incise® lens and, like the newer lens, is a one-piece aberration-neutral aspheric IOL with four angulated haptics. However, unlike the Incise it is composed of an older less stiff hydrophilic material. The results in terms of safety and predictability were essentially the same in the two groups. At 30 days' follow-up the mean corrected distance visual acuity was 0.93 in the Incise group 1.4mm incision group and 0.94 in the Akreos 1.5mm incision group. The endothelial cell counts 2026.99 cells/mm2 and 2102.96, respectively. There were no severe complications in either group.

“Both techniques appeared to be safe and effective with a rapid visual recovery and high patient satisfaction. The incisions in both the groups achieve a fast healing since the first week of follow-up with only temporary morphological alterations detectable through anterior segment imaging,” Dr Torlai said. However, he noted the Incise groups had significantly fewer instances of endothelial gaping (p = 0.04) and local detachment of Descemet’s membrane (p = 0.03) in the first postoperative days.

“Biaxial-MICS and implantation of the Incise IOL through 1.4mm incisions is both minimally invasive and the corneal healing is faster, even comparing it to a similar surgical technique in which incisions are slightly larger,” Dr Torlai concluded.