Forty-four eyes of 29 Asian patients with between -6.00 and -18.25 diopters (D) of myopia and -1.00 to -4.50 D of astigmatism were evaluated after implantation of the Toric Implantable Collamer Lens (TICL).

The Visian TICL is surgically inserted into the eye between the iris and the eye’s natural crystalline lens. In this position, the lens essentially becomes an invisible contact lens inside the eye.

Unlike other refractive surgery procedures like LASIK and PRK, implantation of the Visian TICL does not remove tissue from the cornea. Instead, a small incision similar to one used in cataract surgery is made near the periphery of the cornea and the foldable phakic IOL is inserted into the eye.

At 6 months after surgery, 71 percent of eyes in the study had uncorrected visual acuity (UCVA) of 20/20 or better, and 94 percent had UCVA of 20/25 or better.

Other findings 6 months after surgery include:

• 77 percent of eyes had less than -1.00 D of astigmatism remaining.
• 60 percent of eyes were within 0.50 D of the desired correction, and 86 percent were within 1.00 D of the desired correction.
• 46 percent of eyes had best spectacle-corrected visual acuity (BSCVA) of 20/15 after surgery, compared with 23 percent prior to surgery.
• 94 percent of eyes had BSCVA of 20/20 or better after surgery, compared with 77 percent prior to surgery.
• 1 eye (2.9 percent) lost one line of BSCVA after surgery, and no eyes lost more than one line of BSCVA.
• 31 percent of eyes gained 1 line of BSCVA after surgery, and 8.6 percent gained two lines of BSCVA.

The authors concluded the outcomes, predictability and safety of Toric Implantable Collamer Lenses implanted in Asian eyes for the correct of high myopia and astigmatism are comparable to FDA data on TICLs implanted in non-Asian eyes, and no safety issues were identified in this study.

SOURCE: Toric Implantable Collamer Lens for high myopic astigmatic Asian eyes. Ophthalmology. December 2009.

The Visian ICL, like other phakic IOLs, is implanted inside the eye without removing the eye’s natural lens. The phakic IOL procedure primarily is designed to correct high amounts of nearsightedness that may not be effectively treated with LASIK and other laser vision correction procedures.

Visian ICL: Study design

The study evaluated the visual outcomes and safety of the Visian ICL over a 4-year period after implantation in 56 myopic eyes. The amount of nearsightedness in the eyes prior to surgery ranged from -4.00 to -15.00 diopters (D).

Safety, efficacy, refractive stability and adverse events were evaluated 1, 3, 6, 12, 24 and 48 months after surgery.

Visian ICL: Study results

Four years after Visian ICL surgery in this group of eyes, the researchers found:

• Mean uncorrected visual acuity was 20/20.
• Mean best spectacle-corrected visual acuity was better than 20/15.
• 79 percent of eyes were within 0.50 D of the targeted correction.
• 93 percent of eyes were within 1.00 D of the targeted correction.
• The correction provided by the Visian ICL was stable, with a mean change in manifest refraction of -0.24 D from 1 month to 4 years after surgery.

No vision-threatening complications occurred in any eye during the 4-year follow-up period of the study.

About the Visian ICL

The Visian ICL is a “posterior chamber” phakic IOL, meaning it is implanted behind the iris and pupil of the eye.

The device is called an implantable “collamer” lens because it is made of a biocompatible collagen copolymer.

The Visian ICL is manufactured by STAAR Surgical (Nidau, Switzerland).

SOURCE: Four-year follow-up of posterior chamber phakic intraocular lens implantation for moderate to high myopia. Archives of Ophthalmology. July 2009.