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By Cheryl Guttman

PHILADELPHIA — Although recent FDA trials suggest good results with the redesigned Implantable Contact Lens (ICLTM, Staar) in moderate-to-high ametropia, questions remain about the risk of cataract formation.
Robert Gale Martin MD presented two-year results from the US FDA clinical trial of the hyperopic ICL at the annual ASCRS Symposium on Cataract, Refractive and IOL Surgery.
He presented data on 183 eyes of 102 patients. Spherical equivalent (SE) for the group ranged from +1.63 D to +11.88 D and all eyes had no more than 2.5 D of cylinder.
At all follow-up intervals, approximately 86% of eyes had UCVA of 20/40 or better and 43% saw 20/20 uncorrected.
At 12 months, 70% of eyes had achieved UCVA improvements of seven lines or more. At two years, BSCVA was 20/40 or better in all eyes; 20/20 or better in about 75%; and within one line of the preoperative level in all but one eye.

“The interim results of the US FDA trial show the ICL is an effective and stable alternative for correcting moderate-to-high hyperopia. Careful candidate selection is always critical but in the hyperopes it is especially important to identify eyes with an angle large enough to accept the implant,” Dr Martin said.
He added that patient satisfaction ratings from this study indicate 92% were extremely or very satisfied with the ICL and the remaining 8% were moderately to fairly satisfied.
Eligible patients were allowed to have preoperative BSCVA of up to 20/80. Nearly 20% of eyes had some preoperative condition that could affect the outcome, including most commonly amblyopia (9.8%) and non-visually significant cataract (6.6%).

The visual results were even better in the two-year analysis of the Phase III FDA myopia trial, which included data from 532 eyes of approximately 300 patients.
The patients enrolled received implants ranging in power from -3.0 D to -20 D and had a mean spherical equivalent (SE) of -10.2 D. However, some of the participants had an axial myopic error of greater than -20 D and were intentionally left undercorrected.
With 98% accountability at two years, UCVA was 20/40 or better in 92% of eyes. As in the hyperopia study, refractive stability was excellent over time and mean SE at two years was -0.68 D.
The BSCVA outcomes were the most impressive vision results of the study, reported US specialist James Salz MD.

“The myopic ICL provides an image magnification effect and about half the patients benefited with a gain of at least one line in BSCVA. That is one of the major advantages of this procedure compared with laser vision correction,” he said.
Complication rates, including the development of lens opacities, were favourably low in the US trials. Surgeons needed to remove and reinsert the ICL on the day of surgery in 2% of eyes in both studies.

They repositioned or replaced lenses on another day for reasons that included incorrect power or size of the phakic implant in 0.2% of cases.
In the early postoperative period, there were some acute IOP increases but none required medical treatment. A little more than 7% of hyperopic eyes and 3.5% of myopic eyes required an additional Nd:YAG iridotomy, enlargement of an existing iridotomy or surgical iridectomy early after surgery. Iritis occurred in 1.1% of hyperopic eyes.
During the first two years of follow-up, early anterior subcapsular lens opacity developed in only four (2%) hyperopes. One patient required cataract surgery with ICL removal.

However, three of the opacities developed in eyes implanted by a single surgeon and were attributed to measurement error. Late anterior subcapsular opacity (onset greater than 12 months) was noted in only one eye.
In the myopic study, anterior subcapsular opacification developed in 2.7% of eyes. Clinically significant cataract was noted as a late complication in five (0.9%) eyes, two of which required cataract surgery.
The current version of the ICL provides 170 microns more clearance over the crystalline lens and the data indicates that new design has been successful in reducing the risk of cataract.

In 87 eyes implanted with the preceding V3 version of the ICL in US studies, rates of anterior subcapsular opacities, clinically significant cataract and cataract surgery were 12.6%, 9.2% and 6.9%, respectively, Dr Salz explained.
“Overall, the results from this study are very promising. Considering the potential advantages of vision correction with posterior chamber phakic IOLs, I look forward to FDA approval of the ICL.

“At the same time, however, surgeons must be aware that phakic IOL implantation is intraocular surgery and so there are some potentially serious risks, including cystoid macular oedema, endophthalmitis, iritis, cataract and pigmentary glaucoma,” Dr Salz said.
German investigator Barbara Lege MD reported results of a study which included 286 myopes and 53 hyperopes carried out at her Alz Augenklinik institution in Munich.
The investigation corroborated the efficacy and predictability findings of the US FDA trials, but also served to drive home Dr Salz’s point about the inherent dangers of intraocular surgery.

Twelve-month data demonstrated very favourable predictability results, taking into account that some very high myopes were intentionally undercorrected.
About half the myopes were corrected within 0.5 D of intended, three-quarters were ± 1.0 D and 95% were within 2.0 D.
The refractive outcomes were very similar among the hyperopes, with 60% within ± 0.5D with intended correction, 72% within ±1.0 D and all within 2.0 D of intended refraction.
As in the US trial, nearly 50% of myopic eyes showed a one line or greater gain from baseline BSCVA at one year; that level of improvement was achieved by 17% of hyperopes.

However, cataract development accounted for increasing losses in BSCVA and reductions in efficacy over time.
Lens opacities developed in 14% of myopes and 21% of the hyperopes. Rates of cataract surgery in the myopic and hyperopic groups were 3.8% and 13%, respectively.
At one year, 6% of myopes and 35% of hyperopes experienced a one-line loss from the baseline BSCVA level due to cataract formation, while two lines of BSCVA were lost by 1% of myopes and 13% of hyperopes.
Her Alz Augenklinik colleague, Markus Bauer MD, remains unconvinced that modifications in ICL design have been completely successful in addressing the risk of cataract.

“In our series, we have not noticed the incidence of cataract formation decreasing with use of the most recent versions of the ICL. It is our impression that the risk factors for lens opacities are little or no vault; very high degrees of ametropia; presbyopic age and the former reduction of lens length by STAAR in hyperopic cases,” Dr Bauer said.

At three months after implantation, 67% of myopes had UCVA within one line or better than their preoperative BSCVA. However, with the onset and progression of lens opacities, the efficacy rate fell to 60% at six months and 52% at one year. Among the hyperopes, efficacy rates declined from 58% at three months to 48% at one year.
“For the time being, we consider indications for the ICL as treatment of myopia of -10 D or more and hyperopia of +3.0 D or greater.

“For patients with refractive errors in those ranges, the ICL is a good alternative to other options, such as clear lens exchange or the iris-claw phakic IOL because it has the advantages of reversibility, placement through a small incision and preservation of accommodation,” Dr Lege said.
She added that in cases of lower ametropia, she still considers LASIK a better choice due to the risk of intraocular complications with the ICL, particularly cataract development.

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