Encouraging Early Results with New Accommodating IOL

Tarek Shaarawy, MD

By Roibeard O’hEineachain

AMSTERDAM - Combining deep sclerectomy with a collagen implant in glaucoma patients can achieve better IOP control over the long term than deep sclerectomy and does not appear to increase the rate of complications, according to Tarek Shaarawy, MD, who presented his findings here at the XIX Congress of the ESCRS.

A comparative study involving 104 eyes in 104 patients with a mean follow-up of nearly four years showed that those undergoing deep sclerectomy with the implants had a greater reduction of IOP, higher complete and qualified success rates, and required fewer medications than those who underwent deep sclerectomy alone, said Dr. Shaarawy, Hopital Ophthalmiques Jules Gonin, Lausanne University, Switzerland.

Clear cornea incision,	Phacoemulsification
Removal of ALL cortical remnants with I&A	The IOL is placed within the injector cartridge
Injection and unfolding of the Accomodating IOL within the capsular bag	Haptics have unfolded. The last 4th haptic appears still folded
	The IOL is well centered, viscoelastic is removed with I&A

"The era of implants started in the 1990s with the description of the implant by Vladimir Korozov from the former USSR. The idea of the collagen implant is to occupy the intra-scleral space that is surgically created in order to bridge the maximum healing process, the implant remains in place for between six to nine months after which it is absorbed.”
“A previous comparative study published in 1997 by Santchez and Mermoud showed that 86 eyes with an implant had a higher complete and qualified success with fewer post-operative medications than 82 eyes without an implant after a mean follow-up of less than one year. The results of our current study indicate that those benefits persist over the long term,” he added.

The patients in the randomised prospective trial had medically uncontrolled primary or secondary open-angle glaucoma. All patients underwent deep sclerectomy by the same surgeon, half of them with and half of them without a collagen implant sutured into the scleral bed. The age, sex, and race distributions were comparable in the two groups as were the pre-operative number of medications and IOP. The mean follow-up period was 44 months for both groups.

On the first post-operative day the mean IOP fell from a pre-operative value of 23.3 mmHg to 6.1 mmHg in the deep sclerectomy group, and from 25.6 mmHg to 5.1 mmHg in the deep sclerectomy plus implant group. At 48 months the mean IOP was reduced by 40 % in the deep sclerectomy group compared to a 50% reduction in the implant group. Furthermore, only 34.6% of those without the implant maintained an IOP below 21 mmHg without medication at four years, compared to 63.4% with the implants. Moreover, 94% of those with the implants achieved an IOP below 21 mmHg at final follow-up with or without medication compared to 78.8% of those without the implants.

Similar Complication Rates
Complication rates were similar in the two groups. Injections of 5-FU were necessary in 20 eyes with the implants and in 17 eyes without the implants. There were four hyphaemas in the implant group and eight in the deep sclerectomy group. There was one case of hypotony in the deep sclerectomy group and none in the implant group. There were seven Seidel positives among the eyes with implants and two among those without the implants.

In addition, three eyes in the deep sclerectomy group and two in the implant group underwent needling procedures. Goniopunctures were performed with a similar frequency in the two groups (21 eyes in the deep sclerectomy group and 25 in the implant group) and were carried out using the q-switch mode of a Yag laser delivering up to 15 pulses of 4-5 millijoules.

“The use of a collagen implant in deep sclerectomy seems to enhance the success rate and lower the need for post-operative medications. Issues concerning the mechanism of function of the implant and the effect of size, material and shape of the implant still deserve further attention,” Dr Shaarawy concluded.

Dr. Shaarawy’s co-authors were Andre Mermoud, MD, C. Nguyen, MD, F. Achach, MD, C. Schnyder MD, also at the Hopital Ophthalmiques Jules Gonin.