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Safety and effectiveness of a single-piece hydrophobic acrylic intraocular lens (enVista®) - results of a European and Asian-Pacific study.

Heiner P, Ligabue E, Fan A, Lam D - Clin Ophthalmol (2014)

Bottom Line: The primary safety endpoint was the occurrence of adverse events, and the primary effectiveness endpoints included visual and refractive outcomes and stability, with data collected up to 2 years post-procedure.This study, which enrolled all comers, provided evidence of the excellent safety and effectiveness of the MX60 IOL in standard practice.Favorable clinical outcomes included outstanding visual and refractive outcomes and stability.

View Article: PubMed Central - PubMed

Affiliation: Vision Eye Institute, Southport, QLD, Australia.

ABSTRACT

Purpose: To evaluate the safety and effectiveness of a single-piece hydrophobic acrylic intraocular lens (IOL) (enVista® MX60; Bausch and Lomb Incorporated, Rochester, NY, USA) following implantation to correct aphakia subsequent to extracapsular cataract extraction in adults.

Subjects and methods: This was an open-label, non-interventional, observational study conducted in 19 university and private-practice settings in Europe and the Asia-Pacific region to investigate clinical outcomes of the MX60 IOL in standard practice. Eligible subjects were at least 18 years of age and had undergone standard phacoemulsification and extracapsular cataract extraction with implantation of the MX60 IOL. The primary safety endpoint was the occurrence of adverse events, and the primary effectiveness endpoints included visual and refractive outcomes and stability, with data collected up to 2 years post-procedure.

Results: In this multicenter study, pooled data of 255 eyes were collected and analyzed. Excellent visual and refractive outcomes and stability were demonstrated. At postoperative visit 4 (61-180 days postoperative), 62.2% of subjects achieved a Snellen best-corrected distance visual acuity (CDVA) of 20/20 (decimal 1.00), and 97.8% of subjects achieved a CDVA of 20/40 (decimal 0.50) or better. One eye (1.0%) underwent neodymium:yttrium aluminum garnet capsulotomy at 12 months post-procedure. No glistenings of any grade were reported for any subject at any visit. Adverse events were infrequent and were consistent with incidences generally reported with cataract surgery.

Conclusion: This study, which enrolled all comers, provided evidence of the excellent safety and effectiveness of the MX60 IOL in standard practice. Favorable clinical outcomes included outstanding visual and refractive outcomes and stability. No glistenings were reported at any postoperative visit.

No MeSH data available.


Related in: MedlinePlus

The design of the MX60 (Bausch and Lomb Incorporated, Rochester, NY, USA) intraocular lens.
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f1-opth-8-629: The design of the MX60 (Bausch and Lomb Incorporated, Rochester, NY, USA) intraocular lens.

Mentions: The biconvex lens optic has a body diameter of 6.0 mm and an overall length (diameter) of 12.5 mm (Figure 1). The MX60 IOL has aberration-free aspheric optics and modified C-loop haptics.12–14 The anterior edge is designed to allow anterior capsulorhexis adherence for improved lens centration. The 360° square posterior edge is designed to minimize the development of PCO (Figure 2).15 The MX60 IOL features step-vaulted haptics that translate the optic posteriorly for direct contact with the capsular bag in addition to a sharp 360° square barrier edge to inhibit lens epithelial cell migration. In addition, the haptics have fenestrations intended to prevent transfer of stress from the haptic to the optic.


Safety and effectiveness of a single-piece hydrophobic acrylic intraocular lens (enVista®) - results of a European and Asian-Pacific study.

Heiner P, Ligabue E, Fan A, Lam D - Clin Ophthalmol (2014)

The design of the MX60 (Bausch and Lomb Incorporated, Rochester, NY, USA) intraocular lens.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3974695&req=5

f1-opth-8-629: The design of the MX60 (Bausch and Lomb Incorporated, Rochester, NY, USA) intraocular lens.
Mentions: The biconvex lens optic has a body diameter of 6.0 mm and an overall length (diameter) of 12.5 mm (Figure 1). The MX60 IOL has aberration-free aspheric optics and modified C-loop haptics.12–14 The anterior edge is designed to allow anterior capsulorhexis adherence for improved lens centration. The 360° square posterior edge is designed to minimize the development of PCO (Figure 2).15 The MX60 IOL features step-vaulted haptics that translate the optic posteriorly for direct contact with the capsular bag in addition to a sharp 360° square barrier edge to inhibit lens epithelial cell migration. In addition, the haptics have fenestrations intended to prevent transfer of stress from the haptic to the optic.

Bottom Line: The primary safety endpoint was the occurrence of adverse events, and the primary effectiveness endpoints included visual and refractive outcomes and stability, with data collected up to 2 years post-procedure.This study, which enrolled all comers, provided evidence of the excellent safety and effectiveness of the MX60 IOL in standard practice.Favorable clinical outcomes included outstanding visual and refractive outcomes and stability.

View Article: PubMed Central - PubMed

Affiliation: Vision Eye Institute, Southport, QLD, Australia.

ABSTRACT

Purpose: To evaluate the safety and effectiveness of a single-piece hydrophobic acrylic intraocular lens (IOL) (enVista® MX60; Bausch and Lomb Incorporated, Rochester, NY, USA) following implantation to correct aphakia subsequent to extracapsular cataract extraction in adults.

Subjects and methods: This was an open-label, non-interventional, observational study conducted in 19 university and private-practice settings in Europe and the Asia-Pacific region to investigate clinical outcomes of the MX60 IOL in standard practice. Eligible subjects were at least 18 years of age and had undergone standard phacoemulsification and extracapsular cataract extraction with implantation of the MX60 IOL. The primary safety endpoint was the occurrence of adverse events, and the primary effectiveness endpoints included visual and refractive outcomes and stability, with data collected up to 2 years post-procedure.

Results: In this multicenter study, pooled data of 255 eyes were collected and analyzed. Excellent visual and refractive outcomes and stability were demonstrated. At postoperative visit 4 (61-180 days postoperative), 62.2% of subjects achieved a Snellen best-corrected distance visual acuity (CDVA) of 20/20 (decimal 1.00), and 97.8% of subjects achieved a CDVA of 20/40 (decimal 0.50) or better. One eye (1.0%) underwent neodymium:yttrium aluminum garnet capsulotomy at 12 months post-procedure. No glistenings of any grade were reported for any subject at any visit. Adverse events were infrequent and were consistent with incidences generally reported with cataract surgery.

Conclusion: This study, which enrolled all comers, provided evidence of the excellent safety and effectiveness of the MX60 IOL in standard practice. Favorable clinical outcomes included outstanding visual and refractive outcomes and stability. No glistenings were reported at any postoperative visit.

No MeSH data available.


Related in: MedlinePlus