Long-term effectiveness and safety of a three-piece acrylic hydrophobic intraocular lens modified with hydroxyethyl-methacrylate: an open-label, 3-year follow-up study

Figures & data

Figure 1 Best Spectacle-Corrected Visual Acuity status 20/40 or better at 1-, 2-and 3-year postoperative follow-up visits in patients implanted with IOL Model MA60NM – “all implanted” group and “best case” group.

Abbreviation: IOL, intraocular lens.

Table 1 The Best Spectacle-Corrected Visual Acuity status 20/40 or better at 1-, 2- and 3-year postoperative follow-up visits with IOL Model MA60NM, by age category – “all implanted” group

Age category, n (%)	1-Year N=189	2-Year N=138	3-Year N=138
<60 years	5 (100)	5 (100)	5 (100)
60–69 years	45 (100)	38 (100)	38 (97.4)
70–79 years	84 (96.6)	67 (95.7)	68 (95.8)
≥80 years	37 (88.1)	20 (80.0)	19 (82.6)

Table 2 Cumulative serious adverse events incidence rates through 1 year with IOL Model MA60NM vs ISO Grid Rates – “all implanted” group

Serious adverse event	Model MA60NM, n (%) N=189	ISO grid (%)
Cystoid macular edema	2 (1.1)	3.0
Hyphema	0	N/A
Hypopyon	0	0.3
Intraocular infection/endophthalmitis	0	0.1
Lens dislocation	0	0.1
Pupillary block	0	0.1
Retinal detachment/repair	0	0.3
Secondary surgical intervention	1 (0.5)	0.8
Iridectomy for pupillary block	0	N/A
Repositioning of IOL	0	N/A
IOL removal due to inflammation	1 (0.5)	N/A
Other	0	N/A

Notes: The incidence rates are based upon the number of eyes with an event divided by the number of eyes implanted. Patients had no duplicate adverse events at different visits. ISO grid rates are based on BS EN ISO 11979-7:2006.

Abbreviations: IOL, intraocular lens; N/A, not available.

Table 3 Incidence of postoperative non-serious AEs through 1 year with IOL Model MA60NM – “all implanted” group

Adverse event	Model MA60NM, n (%) N=189
None	79 (41.8)
Corneal edema	40 (21.2)
Iritis (3 cells in a field or greater)	2 (1.1)
Macular degeneration	19 (10.1)
Pigment precipitation on lens	18a (9.5)
Vitreous detachment	6 (3.2)
Macular edema	2 (1.1)
Raised IOP requiring treatment	7 (3.7)
Other	76 (40.2)

Notes: The incidence rates in this table are based upon the number of eyes with an event divided by the number of eyes implanted.

a Includes five patients with “Other” IOL observations which indicate pigment precipitates on the IOL.

Abbreviations: AE, adverse event; IOL, intraocular lens; IOP intraocular pressure.

Table 4 Incidence of PCO at 1-, 2-, and 3-year postoperative follow-up visits with IOL Model MA60NM – “all implanted” group

PCO n (%)	1-Year N=179	2-Year N=138	3-Year N=138
None	126 (70.4)	109 (79.0)	105 (76.1)
Clinically non-significant	50 (27.9)	26 (18.8)	30 (21.7)
Clinically significant	2 (1.1)	3 (2.2)	3 (2.2)
Clinically significant requiring Nd: YAGa	1 (0.6)	0	0

Notes:

a One additional case of clinically significant PCO requiring YAG was recorded during an unscheduled visit during 1-year follow-up period. Thus, the incidence of Nd: YAG procedure at 1- and 3-years was 1.1% (2/179) and 1.4% (2/138), respectively.

Abbreviations: IOL, intraocular lens; PCO, posterior capsular opacification; Nd: YAG, Neodymium: Yttrium Aluminum Garnet laser capsulotomy.