Visian ICL™ Clinical Results - Instead of Correcting the Eye, Simply Correct the Vision
Data from research, including the FDA, show that corrective eye surgery using the Visian ICL is safe and effective for the correction or treatment of myopia. It also shows that the Visian ICL has some advantages over refractive surgical procedures such as PRK and LASIK, and has a lower chance of inducing higher order aberrations compared to LASIK.
American Academy of Ophthalmology - FDA Clinical Trial of Visian ICL for Moderate to High Myopia: Three-Year Follow-Up
In the 2004 ICL clinical trial three-year follow-up conducted by the FDA, investigation results "support the safety, efficacy, and predictability of Visian ICL surgery to treat moderate to high myopic errors."1
The three-year data, based on the assessment of 526 eyes of 294 patients, also produced the following refractive results:
- 99 percent of patients were satisfied/very satisfied with their results.
- 98.3 percent of patients had uncorrected visual acuity of 20/40 or better.
- Once vision was corrected, the correction was stable and did not change over the follow up period.
- Additionally, the incidence of glare, halos, double vision, night vision problems, and night driving difficulties decreased or remained unchanged from before surgery.
It is significant to note that in this study states that the "FDA granted the ICL file" (Visian ICL) "'expedited review' status for high myopia. The FDA's guidance document on expedited review states, 'Expedited review will generally be considered when a device offers a potential for clinically meaningful benefit as compared to the existing alternatives (preventative, diagnostic, or therapeutic) or when the new medical device promises to provide a revolutionary advance (not incremental advantage) over currently available alternative modalities.'" 1
Read more about the Toric ICL* for Moderate to High Myopic Astigmatism.
Comparison of ICL and LASIK for Moderate to High Myopia
Visual acuity, or the vision readable at a particular distance, is not an accurate measurement of visual quality. While two individuals may see 20/20 (visual acuity), each individual's quality of vision may differ. This “quality of vision” was quantified and studied in the article authored by Edwin T. Sarver, PhD et al.2
A comparison of higher order aberrations, or distortions in vision that may result from vision correction surgery, were objectively measured following LASIK and Visian ICL surgery. The results were then calculated and simulated retinal images (what the patient would see) were compared.
A simulation of induced spherical and coma aberrations after implantation of the Implantable Contact Lens. (Photos courtesy of Ed Sarver, PhD)
A simulation of induced spherical and coma aberrations after LASIK.
The LASIK eyes yielded an average three times more spherical aberration and two times more coma than the Visian ICL eyes, resulting in the simulated images above.
A study entitled Comparison of Implantable Contact Lens and Laser Assisted in Situ Keratomileusis for Moderate to High Myopia conducted by the Center for Clinical Research features a two-year clinical study comparing the results of ICL and LASIK corrective eye surgery. It reports the following:
- The Visian ICL creates favorable outcomes in stability and provides high-quality vision even to those patients requiring high corrections.
- The Visian ICL has some advantages over LASIK; the patient’s pupil size is less important and a patient doesn’t need to have thick corneas to successfully undergo myopia treatment with the Visian ICL.
- Since the Visian ICL allows for corrective eye surgery with no permanent structural change to the cornea, it can be removed if the patient dislikes the results – an option not available to LASIK patients.
The discussion in the report states that the "dramatic improvement of the ICL over the LASIK procedure is not unexpected since it is more accurate to manufacture the exact correction required in a HEMA material than to ablate the correction onto the corneal tissue, which is then subject to corneal healing. This is especially dramatic in view of the fact that 23% of the LASIK cases required enhancement surgery compared with only 4.3% in the ICL cases… The ICL offers the moderate to highly myopic patient a viable alternative to corneal laser refractive surgery."3
To learn more, please read the following article based on the findings of this comparison:
"Implantable Contacts Make Their Mark"
VISIAN ICL Myopia Treatment
As studies show, corrective eye surgery with the Visian ICL presents a low risk of complications, predictable outcomes, excellent vision correction, and a low incidence of high-order aberrations – lower than currently offered by refractive surgical procedures such as LASIK. The Visian ICL has some advantages over PRK and LASIK corrective laser eye surgery, and can improve the vision of those who may not be good LASIK candidates. Professionals wishing to learn more about the Visian ICL clinical results in patients with mild, moderate, or severe myopia should contact STAAR® Surgical Company.
1. ICL in Treatment of Myopia (ITM) Study Group. United States Food and Drug Administration clinical trial of the Implantable Collamer Lens (ICL) for moderate to high myopia. Ophthalmology. 2004;111:1683-1692
2. Sarver EJ, Sanders DR, Vukich, JA. Image quality in myopic eyes corrected with laser in situ keratomileusis and phakic intraocular lens. J Refract Surg. 2003;19(4):397-404.
3. Sanders DR, Vukich JA. Comparison of implantable contact lens and laser assisted in situ keratomileusis for moderate to high myopia. J. Cornea Ext Dis, 2003;22(4):324-331.
As an advanced myopia treatment, corrective eye surgery with the Visian ICL implantation has shown to be safe, effective, predictable, and less likely to induce higher order aberrations, anterior subcapsular opacities, and other side effects than other refractive surgeries. Contact STAAR Surgical Company for more Visian ICL clinical results.
Visian ICL Glossary
When researching Visian ICL, you may encounter unfamiliar terminology related to this and other products and procedures. For your convenience, the Visian ICL Glossary defines many of the ophthalmic terms used throughout this website.