April 15, 2003
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ICL for moderate to high myopia is safe, effective, predictable

The STAAR implantable contact lens compares favorably to LASIK in an FDA trial; high patient satisfaction found.

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MADISON, Wisc. — The STAAR Surgical implantable contact lens offers a safe, effective and stable alternative for the correction of moderate to high myopia, according to 24-month outcomes.

“I believe the implantable contact lens is going to be an important adjunct for refractive surgery. I think there will be a number of patients for whom corneal stability is an issue in the lower ranges: either corneas that are too thin or patients who may have corneal irregularities that would make them less-than-ideal candidates for LASIK,” said John A. Vukich, MD, a surgical director at the Davis Duehr Dean Medical Center here.

For patients with 6 D to 8 D of myopia and above, the ICL’s performance is excellent and compares favorably to LASIK in the higher ranges, and the lens outperforms LASIK in the ranges of –10 D and above,” said Dr. Vukich, the medical monitor for the entire Food and Drug Administration trial of the STAAR ICL.

Improved vision

Two-year results of the lens for the multicenter FDA clinical trial were published in Ophthalmology. A total of 523 eyes (291 patients) with between 3 D and 20 D of myopia participated. Regarding postoperative uncorrected visual acuity, 60.1% of patients were 20/20 or better and 92.5% were 20/40 or better.

“This improvement to 20/20 or better occurred immediately in the first postop week and remained stable throughout the follow-up period,” Dr. Vukich said.

Only one case lost more than two lines of best corrected visual acuity, while gains of two or more lines occurred in 55 cases at 6 months and 41 cases at 1 year after ICL surgery.

At the 12-month visit, 96.4% of eyes in the below-7 D group fell within ± 1 D of their attempted correction, 91.9% in the 7 D- to-10 D group and 73.8% in the above-10 D group.

photo
The implantable contact lens unfolding in the anterior chamber.

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Close up of the ICL (inset).

Few adverse events

Adverse events with the STAAR ICL appear to compare extremely favorably to LASIK. There were 11 cases of presumably surgically-induced anterior subcapsular (AS) opacities, and one case of early AS opacity from inadvertent anterior chamber irrigation of preservative-containing solution at surgery. Two cases of late AS opacities (at least 1 year postop) were observed, for which the ICL was removed with cataract extraction.

“Fortunately, when adverse events do occur, they are reversible,” Dr. Vukich said. “The lens can be explanted, or in the rare case of a cataract formation, cataract surgery can be performed. [Overall,] the natural lens tolerates the implantable contact lens very well.”

Patient satisfaction was also high. About 92% of subjects reported they were either “very” or “extremely” satisfied with the lens on a subjective questionnaire. Only four patients reported dissatisfaction. Slightly more patients reported an improvement at 1 year over baseline values for such subjective symptoms as quality of vision, glare, double vision and night-driving difficulties.

“There was only a 3% difference for halos between pre-ICL and post-ICL surgery,” Dr. Vukich said.

Twenty-one patients required secondary surgical intervention for management of acute pressure rises within 1 month after surgery, from small iridectomies (before lens insertion) that were clogged with viscoelastic. But all pressures returned to normal after a secondary procedure, with no loss of BCVA. Moreover, no study patients required long-term glaucoma medication.

“There was also no significant late elevation in IOP after implantation of the lens,” Dr. Vukich said.

Fourth lens version

Dr. Vukich said the STAAR ICL is the first posterior chamber phakic IOL introduced in the United States, and that the FDA data represent the fourth version of the lens.

A study recently accepted for publication found the quality of vision using wavefront analysis was much better with the ICL compared to LASIK.

“There was up to three times as much induced higher-order aberration with LASIK patients in a similar range of myopia. These findings are certainly consistent with our reports of patient acceptance and quality of vision with the ICL,” Dr. Vukich said

Three-year data of the STAAR ICL are currently being analyzed for submission to the FDA later this year.

“These new data closely mirror the 12-month data. There have been no surprises or changes over 3 years. The results of the lens continue to be stable and performance is comparable,” Dr. Vukich said.

“I believe the implantable contact lens offers a reliable alternative for the correction of moderate to high myopia. The lens appears to be both safe and offers superior quality of vision,” he said.

Other versions of ICL

A toric (for treating both myopia and astigmatism) and hyperopic version of the STAAR ICL are both currently under investigation. The toric lens study is a limited trial and will primarily evaluate efficacy.

“Early results (6 months or less) show excellent predictability — similar to what we are seeing in the cohort of myopia only — although the uncorrected visual acuities are slightly better because of correcting for astigmatism as well,” John A. Vukich, MD, said.

The hyperopic study also appears to be demonstrating excellent predictability. He added that one of the challenges in a hyperopic population is that the anterior chamber depth tends to be smaller, so there are some physical limitations that curtail the number of patients who can receive an ICL or any phakic IOL.

“The fit of the lens becomes an important issue,” he said.

For Your Information:
  • John A. Vukich, MD, can be reached at Davis Duehr Dean Center for Refractive Surgery, 1025 Regent St., Madison, WI 53715; (608) 282-2177; fax: (608) 282-2048; e-mail: javukich@facstaff.wisc.edu. Dr. Vukich is a paid consultant to STAAR Surgical and is the medical monitor for the FDA trial of the STAAR ICL.
  • STAAR Surgical, manufacturer of the implantable contact lens, can be reached at 1911 Walker Ave., Monrovia, CA 91016; (626) 303-7902; fax: (626) 358-9187.
Reference:
  • The Implantable Contact Lens in Treatment of Myopia (ITM) Study Group. U.S. Food and Drug Administration clinical trial of the implantable contact lens for moderate to high myopia. Ophthalmology. 2003;110:255-266.