Toric ICLs get high marks in retrospective analysis

April 1, 2008

A retrospective analysis of implantation of the toric phakic implantable contact lens in 180 eyes of 95 patients indicates that the procedure is safe, effective, and stable, and has high patient satisfaction levels.

Haugesund, Norway

-After implanting nearly 200 toric implantable contact lenses (ICLs) over the past several years, ophthalmologist Kjell Gunnar Gundersen, MD, PhD, has concluded that the procedure yields good clinical outcomes and high patient satisfaction.

"We regard implantation of toric ICLs for correction of high myopia and astigmatism to be a very safe, effective, and stable procedure. Patient response showed a very high level of satisfaction," said Dr. Gundersen, head of the ophthalmology program at Privatsykehuset Haugesund, Haugesund, Norway.

 Between October 2002 and January 2007, Dr. Gundersen implanted the toric phakic ICL in 180 eyes of 95 patients. The mean age of the patient group was 38.5 years, and the group included slightly more females than males. The mean observation time was 27 months.

Preoperative mean spherical refraction ranged from -16 to +6 D, with regular astigmatism of -1.5 to -6 D. The mean preoperative best-corrected visual acuity was 0.9, which improved to 1.1 D postoperatively. The study eyes gained 2 lines on average.

Efficacy and safety

"Predictability and stability of refraction were also very excellent," Dr. Gundersen said. "After 1 week, we noticed no change."

 Safety improved throughout the observation period, and efficacy was stable. No enhancements were permitted in the study eyes; about 15% of patients had refractive errors that could not be fully corrected with implantation of the toric ICL.

To learn more about their patients' experiences with the implantation, Dr. Gundersen and his colleagues administered two satisfaction questionnaires to individuals who had undergone surgery between October 2002 and October 2006. With a response rate of nearly 90%, results indicated that the mean patient satisfaction rate was not affected by gender or time since surgery, although a slight decline was observed with increasing age.

Results showed that 90% of patients agreed that the quality of their vision had been dramatically improved by implantation of the toric ICL; 80% agreed that their quality of life had been radically improved; 94% said they definitely would recommend the surgery to friends or family; and 92% responded that they would undergo the same surgery again.

Reduction in visual aids

In response to a separate survey addressing the need for visual aids following surgery, 93% of patients reported that they had no or almost no need for glasses for distance vision, compared with 75% for intermediate vision and 68% for near use.

Dr. Gundersen also noted that 78% of patients reported no increase in visual disturbances following implantation. During the daytime, the reported disturbances were limited to occasional episodes, and up to 75% of patients reported having no problems of this nature. Only 7% reported constant visual disturbances at night, whereas 55% said they did not notice any problems at night or in dim light.

Complications included re-rotation of two lenses in the first postoperative week and a case of subretinal neovascularization about 6 months postoperatively that resulted in a decline in visual acuity from 1.1 to 0.2 D during the acute phase. "After successful photodynamic therapy treatment, visual acuity improved to 0.55 D and has been stable for 2 years now," Dr. Gundersen said.

One case of anterior subcapsular cataract formation occurred, with a subsequent fall in visual acuity from 1.0 to 0.5 D. This patient was scheduled for toric ICL explantation and cataract surgery. No cases of glaucoma, intraocular infection, or acute or chronic uveitis have been seen.OT