Safety and effectiveness of a glistening-free single-piece hydrophobic acrylic intraocular lens (enVista)

Figures & data

Table 1 Eligibility criteria

Inclusion criteria

• Clinically documented diagnosis of age-related cataract that was considered amenable to treatment with standard phacoemulsification/extracapsular cataract extraction

• Clear intraocular media other than cataract

• Age ≥18 years

• Able to read, understand, and provide written informed consent

• Required a lens power from 16.5 to 24.0 D

• Had a BCVA equal to or worse than 20/40 in the study eye, with or without a glare source

• Had a BCVA projected to be better than 20/30 after IOL implantation in the study eye

Exclusion criteria

• Any anterior segment pathology for which extracapsular phacoemulsification cataract surgery may be contraindicated

• Uncontrolled glaucoma or current treatment for glaucoma in either eye

• Previous retinal detachment or clinically significant retinal pathology in the operative eye

• Proliferative or clinically significant nonproliferative diabetic retinopathy in either eye

• Congenital bilateral cataracts

• Marked microphthalmos or aniridia in either eye

• BCVA of 20/200 (logMAR 1.0, 6/60) or worse in the fellow eye

• Previous ocular surgery in the operative eye

• Previous recipient of a study IOL in the fellow eye

• Inability to achieve a minimum pharmacologic pupil dilation of 5.0 mm

• Preoperative corneal astigmatism of a magnitude that required surgical treatment at any time during the study

• Preoperative corneal astigmatism greater than 1.5 D

Abbreviations: BCVA, best-corrected visual acuity; IOL, intraocular lens; logMAR, logarithm of minimum angle of resolution.

Figure 1 (A) Design of the MX60 intraocular lens (Bausch & Lomb, Rochester, NY, USA). (B) Posterior surface facing toward the right side of the page. The haptics are offset anteriorly with respect to the optic body, which enables consistent posterior movement of lens optic under haptic compression. Images courtesy of David Spalton, FRCS, FRCP, FRCOphth.

Figure 2 Flowchart showing the basis for distribution of subjects into each analysis cohort.

Note: *Three subjects removed due to preoperative corneal astigmatism > 1.5 D (exclusion criterion no 13).

Table 2 Subject demographics (n = 122)

Variable
Sex, n (%)
Male	53 (43.4)
Female	69 (56.6)
Age in years at surgery date ± SD (range)
Overall	69.0 ± 8.0 (46 to 93)
Male	69.1 ± 7.6 (49 to 83)
Female	69.0 ± 8.3 (46 to 93)
Subjects by age in years, n (%)*
<60	13 (10.7)
60–69	50 (41.0)
70–79	54 (44.3)
≥80	5 (4.1)
Ethnicity, n (%)*
African American	1 (0.8)
Caucasian	119 (97.5)
Hispanic	2 (1.6)

Note: *Percentages may not total 100 due to rounding.

Abbreviation: SD, standard deviation.

Table 3 Ocular adverse events in safety-analysis set (n=122)*

Finding	n (%)
Anterior capsule contraction	3 (2.5)
Arcus lipoides	1 (0.8)
Blepharitis	2 (1.6)
Conjunctival hemorrhage	2 (1.6)
Conjunctival hyperemia	3 (2.5)
Conjunctival edema	1 (0.8)
Conjunctivitis	1 (0.8)
Conjunctivitis, allergic	1 (0.8)
Conjunctivitis, viral	1 (0.8)
Corneal abrasion	3 (2.5)
Corneal degeneration	1 (0.8)
Corneal dystrophy	2 (1.6)
Diabetic retinopathy	1 (0.8)
Dry eye	3 (2.5)
Eye hemorrhage	1 (0.8)
Eye irritation	1 (0.8)
Eye pain	1 (0.8)
Hordeolum	1 (0.8)
Intraocular pressure increase	2 (1.6)
Iris hypopigmentation	1 (0.8)
Iritis	3 (2.5)
Keratitis, herpetic	1 (0.8)
Macular degeneration	1 (0.8)
Miosis	1 (0.8)
Pinguecula	1 (0.8)
Punctate keratitis	4 (3.3)
Vision blurred	1 (0.8)
Vitreous detachment	3 (2.5)
Wound secretion	1 (0.8)

Note:

* Includes all ocular adverse events, regardless of relationship to surgery or device, which occurred during the trial.

Figure 3 Best-corrected visual acuity (BCVA) at visit four (days 120–180 postoperative); cumulative percentage of subjects (n = 118).