PR Newswire12.05.19
Johnson & Johnson Vision announced the Food and Drug Administration (FDA) approval and U.S. launch of TECNIS Toric II 1-Piece Intraocular Lens (IOL). This is the first product approved on the new TECNIS Toric II platform, which offers more surface texture and friction on the IOL haptics,1 which hold an IOL in proper position within the eye. The company is launching two post-market clinical trials to demonstrate the rotational stability and visual outcomes offered by the TECNIS Toric II platform. The trials will be conducted at up to 50 sites across the U.S. to collect qualitative and quantitative measures with up to 1,000 patients.
"Today's patients with cataracts not only want clear vision, but also less dependence on glasses following surgery—something that has historically been challenging to deliver for those with astigmatism," said Daniel H. Chang, M.D., Cataract and Refractive Surgeon at Empire Eye & Laser Center. "In my experience, toric IOLs can produce excellent visual outcomes, however, even small misalignments of the lens can lead to blurred vision. I'm looking forward to being part of the post-market clinical trials to further evaluate the rotational stability of TECNIS Toric II IOL in a large population of patients."
Astigmatism is highly prevalent, affecting nearly half of the 24.4 million cataract patients in the U.S., yet it often goes untreated during cataract surgery.2 Toric IOLs are the most predictable method for correction, however, surgeon concerns around rotational stability may be acting as a barrier to providing treatment.3 Properly implanting a toric IOL can be more challenging than a conventional spherical IOL due to the high degree of precision required to align the lens properly in order to correct the astigmatism present in the eye.4 Movement of the lens after implantation can result in decreased vision and the need for realignment.
"With the launch of TECNIS Toric II IOL, our goal is to provide surgeons with a higher degree of confidence in treating astigmatism so that more cataract patients can enjoy clear, high quality vision," said Xiao-Yu Song, Global Head of Research & Development, Johnson & Johnson Vision. "This advance represents the latest addition to our TECNIS Family of IOLs, building on our proud history of raising the standard of care for patients with cataracts."
References
1 Compared to TECNIS Toric 1-piece IOL.
2 Anderson DF et al. (2018) Global prevalence and economic and humanistic burden of astigmatism in cataract patients: a systematic literature review. Clin Ophthalmol 12: 439-452.
3 Nunez MX, Henriquez MA, Escaf LJ, Ventura BV, Srur M et al. (2019) Consensus on the management of astigmatism in cataract surgery. Clin Ophthalmol 13 311-324.
4 Ma JJ, Tseng SS (2008) Simple method for accurate alignment in toric phakic and aphakic intraocular lens implantation. J Cataract Refract Surg 34 (10): 1631-1636.
"Today's patients with cataracts not only want clear vision, but also less dependence on glasses following surgery—something that has historically been challenging to deliver for those with astigmatism," said Daniel H. Chang, M.D., Cataract and Refractive Surgeon at Empire Eye & Laser Center. "In my experience, toric IOLs can produce excellent visual outcomes, however, even small misalignments of the lens can lead to blurred vision. I'm looking forward to being part of the post-market clinical trials to further evaluate the rotational stability of TECNIS Toric II IOL in a large population of patients."
Astigmatism is highly prevalent, affecting nearly half of the 24.4 million cataract patients in the U.S., yet it often goes untreated during cataract surgery.2 Toric IOLs are the most predictable method for correction, however, surgeon concerns around rotational stability may be acting as a barrier to providing treatment.3 Properly implanting a toric IOL can be more challenging than a conventional spherical IOL due to the high degree of precision required to align the lens properly in order to correct the astigmatism present in the eye.4 Movement of the lens after implantation can result in decreased vision and the need for realignment.
"With the launch of TECNIS Toric II IOL, our goal is to provide surgeons with a higher degree of confidence in treating astigmatism so that more cataract patients can enjoy clear, high quality vision," said Xiao-Yu Song, Global Head of Research & Development, Johnson & Johnson Vision. "This advance represents the latest addition to our TECNIS Family of IOLs, building on our proud history of raising the standard of care for patients with cataracts."
References
1 Compared to TECNIS Toric 1-piece IOL.
2 Anderson DF et al. (2018) Global prevalence and economic and humanistic burden of astigmatism in cataract patients: a systematic literature review. Clin Ophthalmol 12: 439-452.
3 Nunez MX, Henriquez MA, Escaf LJ, Ventura BV, Srur M et al. (2019) Consensus on the management of astigmatism in cataract surgery. Clin Ophthalmol 13 311-324.
4 Ma JJ, Tseng SS (2008) Simple method for accurate alignment in toric phakic and aphakic intraocular lens implantation. J Cataract Refract Surg 34 (10): 1631-1636.
