Clinical assessment of long-term safety and efficacy of a widely implanted silicone intraocular lens material.
OBJECTIVE
To summarize the long-term safety and efficacy, in a large series of patients, of intraocular lenses made from a second-generation silicone material (AMO SLM-2/UV) widely used as an intraocular lens material.


METHODS
This was a prospective study of adult patients who received posterior-chamber intraocular lenses with an optic composed of a high-index-of-refraction, ultraviolet-light-absorbing silicone (AMO SLM-2/UV). In 501 patients, clinical data through 3 years postoperative are presented. Postoperative measurements included spectacle-corrected visual acuity, occurrence of postoperative sight-threatening or lens-related complications, and adverse reactions. Results were compared with the standards established by the US Food and Drug Administration (FDA) for polymethylmethacrylate lenses.


RESULTS
At 1 year, 95.2% (496/521) of all patients in group I achieved corrected visual acuity of 20/40 or better. This compared well with the standard reported for polymethylmethacrylate lenses (88%, 2,521/2,864). At 3 years, 94.3% (347/368) of best-case patients achieved corrected visual acuity of 20/40 or better. The rate of sight-threatening complications reported at the final postoperative examination at 3 years was 2.0% (10/501). The rate of Nd:YAG capsulotomy was 27.5% (138/501) through 3 years.


CONCLUSIONS
Lenses made of the SLM-2/UV silicone material demonstrated safe and effective performance through long-term follow-up at a level equal to or better than established standards for polymethylmethacrylate lenses.
Steinert
R F
RF
Center for Eye Research, Harvard Medical School, Boston, Massachusetts, USA. cristeinett@aol.com
Giamporcaro
J E
JE
Tasso
V A
VA
D000368:Aged; D004868:Equipment Failure; D005128:Eye Diseases / Q000209:etiology; D006801:Humans; D007910:Lenses, Intraocular / Q000009:adverse effects; D008137:Longitudinal Studies; D008875:Middle Aged; D011184:Postoperative Period; D012086:Reoperation; D012449:Safety; D012828:Silicones / Q000009:adverse effects; D014792:Visual Acuity
D012828:Silicones