Toric ICL looks promising for high myopia with astigmatism

October 23, 2004

Data collected through up to 1 year of follow-up in the FDA multicenter clinical trial of the toric ICL (STAAR Surgical) support the efficacy, safety, and predictability of that phakic IOL for correcting myopic astigmatism, said Captain Steven Schallhorn, MD, at the refractive surgery subspecialty day meeting.

New Orleans-Data collected through up to 1 year of follow-up in the FDA multicenter clinical trial of the toric ICL (STAAR Surgical) support the efficacy, safety, and predictability of that phakic IOL for correcting myopic astigmatism, said Captain Steven Schallhorn, MD, at the refractive surgery subspecialty day meeting.

"We are seeing phenomenal clinical outcomes, exception accuracy in both the sphere and cylinder correction, stability that is achieved early and maintained, and no immediate safety issues so far," reported Dr. Schallhorn, director, cornea and refractive surgery, Naval Medical Center, San Diego.

The analyses were based on 133 eyes of 96 patients, of which 61 were seen at 6 months and 18 at 12 months. Patients eligible for the study had between -3 and -20 D of myopia with between -1 and -4 D of cylinder. Mean preoperative values for sphere, cylinder, and manifest spherical equivalent (MSE) for the group were -8.09, -1.97, and -9.07 D, respectively.

At various follow-up visits, mean MSE was 80% were corrected to within 0.5 D of intended refraction and about 90% of patients had UCVA of 20/20 or better.

About 90% of patients had 1 D of residual cylinder and there was excellent correlation between intended cylinder correction and vector achieved cylinder (R² = b 0.85). Assessment of the stability of the cylinder axis indicated that the lens does not appear to be rotating over time.

Patients on average achieved a 1 line gain in BSCVA, and from 1 month onward, there were no patients with a >1 line loss from preoperative BSCVA. Other safety data showed no eyes with inflammation persisting beyond the 1 month visit, IOP increased > 10 mm hg, corneal decompensation or corneal edema. A small anterior subcapsular cataract developed in a single eye, but it has remained stable and the patients UCVA is 20/20.