September 01, 2008
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Pediatric phakic IOL shows promising long-term results

Implantable lenses leave the cornea untouched, which is important in young patients, surgeon says.

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PARIS – Long-term results of monolateral contact lens implants in pediatric patients show encouraging results in terms of safety and efficacy, according to a study in Toulouse, France.

“With the due caution, refractive surgery has been applied to children over the past 10 years. Indications are rare and different from those of adult patients,” Laurence C. Lesueur, MD, said at the annual meeting of the French Society of Ophthalmology.

The Visian ICL (model V2 and V4, STAAR Surgical) was implanted in 18 children with unilateral high myopia who were intolerant to spectacles and contact lenses. Follow-up has now reached 11 years, and the mean follow-up is 8 years.

“The results we have obtained over such a long period of time are highly encouraging. We have reached our goals with … none of the complications that could be expected,” Dr. Lesueur said.

The mean age of the patients was 9 years. Mean preoperative refraction was –12.5 D.

“The mean postoperative refraction was –0.5 D, ranging between –4.5 D and +2.5 D,” she said.

Results

A gain of at least one line of best corrected visual acuity was obtained in about 60% of the cases, and a gain of two or more lines in about 40% of the cases. About one-third of the patients had no loss and no gain because of preoperative problems that made surgery more difficult and less effective, Dr. Lesueur said. Only in one case was there a loss of lines because of postoperative retinal detachment.

Biometrical results showed minimal variation in both axial length and anterior chamber depth. The axial length increased about 1.17 mm, similarly to what was found in the contralateral, non-operated eye (0.8 mm). Anterior chamber depth had a mean variation of 1.122 mm.

“Such a small (3.8%) variation in anterior chamber depth is quite different from that reported in previous studies, which was up to about 15%,” Dr. Lesueur said.

Functional results were rewarding, she noted. Of nine children with strabismus, four were corrected by the implantation of the lens. In four cases, a specific operation was needed.

Binocular vision, which was present in only two cases (12%) preoperatively, was obtained in five more patients after ICL implantation. Better results were obtained in the cases of moderate amblyopia without associated strabismus, Dr. Lesueur said.

Anatomical results were evaluated by ultrasound biomicroscopy and WaveLight’s Allegretto system. The mean anterior chamber depth was 3 mm. The mean vaulting was 265 µm.

“A lower vaulting, between 150 µm and 160 µm, was observed in the three children implanted with the V2 model compared to the V4 model, where the range was 210 µm to 390 µm,” Dr. Lesueur said.

Low rate of complications

The Collamer material of the lens was well-tolerated. No case of inflammation was observed, and only one case of mild capsular opacification was reported in one eye implanted with the V2 ICL model. In this eye, the anterior chamber depth was 3,015 µm and the vaulting was 150 µm. In one case, retinal detachment occurred, Dr. Lesueur said.

The implant was stable, and no lens displacement occurred. There were no pigment deposits on the lens, she said. IOP was not affected and remained between 14 mm Hg and 19 mm Hg in all of the patients.

No adverse effects were seen at corneal level. The corneal endothelium was well-preserved, with a mean endothelial cell count of 2,375 cells/mm2 compared with the 2,991 cells/mm2 of the contralateral eye, she said.

“ICL implantation should be considered as a safe and effective method of addressing unilateral myopia in selected pediatric cases,” Dr. Lesueur said. “Refractive results are satisfactory and stable over time.”

Compared with laser refractive treatments, the implantation of a phakic posterior chamber lens has the advantage of leaving the cornea untouched, which is particularly important in these young patients, she said.

“On the other hand, the quality of life of these children can change dramatically for the better with a treatment that corrects or prevents amblyopia and restores or maintains binocular vision,” Dr. Lesueur said.

For more information:
  • Laurence C. Lesueur, MD, can be reached at Service d’Ophtalmologie, Hôpital Purpan, Place du Docteur Baylac, 31059 Toulouse, France; e-mail: laurence.lesueur@club-internet.fr. Dr. Lesueur has no direct financial interest in the products discussed in this article, nor is she a paid consultant for any companies mentioned.
  • STAAR Surgical AG, maker of the Visian ICL, can be reached at Haupstrasse 104, Postfach 463, CH-2560 Nidau, Switzerland; +41-32-332-8888; fax: +41-32-332-8899; Web site: www.staar.com.

References:

  • Lesueur LC, Arne JL. Phakic posterior chamber lens implantation in children with high myopia. J Cataract Refract Surg. 1999;25:1571-1575.
  • Lesueur LC, Arne JL. Phakic intraocular lens to correct high myopic amblyopia in children. J Refract Surg. 2002;18:519-523.
  • Michela Cimberle is an OSN Correspondent based in Treviso, Italy, who covers all aspects of ophthalmology. She focuses geographically on Europe.