Sept. 1, 2004 — Wish you never had to change your contact lenses? That day may be coming.
The U.S. Food and Drug Administration has just released an update on its long-term clinical trial of implantable collamer lenses, which are used for moderate to high myopia (nearsightedness). People with myopia have more difficulty seeing distant objects as clearly as near objects.
The lens, which is inserted through a tiny incision and placed in front of the eye’s natural lens, has already been shown to be safe and effective. Researchers are tracking how well the results hold up over time.
Previously called “implantable contact lenses,” the FDA prefers the term “implantable collamer lenses” to avoid any confusion with corneal contact lenses (the implantable lenses are made of collamer, a type of collagen).
The trial focused on 526 eyes among some 294 people aged 22-45. After three years with an implantable collamer lens, nearly 59% had 20/20 vision (normal vision) or better, and nearly 95% had at least 20/40 vision (near-normal vision) or better.
Side effects such as seeing glares or halos, experiencing double vision, or having problems with night vision weren’t any worse and decreased in some cases.
Nearly 97% said they would choose to have the implantable collamer implant again.
Since all the participants were 45 or younger, no one knows if the same results would hold true for older patients.
Comparing the lenses with LASIK (refractory) eye surgery, the study showed that the collamer lenses worked better for people with greater nearsightedness. Surgical procedures aimed at improving the focusing power of the eye are called refractive surgery. In LASIK surgery, a special laser reshapes the cornea (the part of the eye that focuses vision), changing its focusing power.
Implantable collamer lenses are not available yet, but two models are in the pipeline for FDA approval. In a news release, the American Academy of Ophthalmology says both lenses are expected to be approved by the FDA around the same time. There is no word on when that will happen.
The study, which appears in the journal Ophthalmology, was funded by STAAR Surgical, the maker of one of the implantable collamer lenses under consideration.