Long-term safety of in-the-bag implantation of a supplementary intraocular pinhole.

PURPOSE: To evaluate the long-term effectiveness and safety of the XtraFocus intraocular pinhole (IOPH) when it is implanted inside the capsular bag.

SETTING

Private practice.

DESIGN

Retrospective consecutive case series.

METHODS

Patients who had an IOPH implanted in the capsular bag together with the primary intraocular lens (IOL) to treat irregular corneal astigmatism secondary to multiple causes were enrolled. The mean follow-up was 16 months (range 7 to 48 months). Patients were assessed in their scheduled follow-up visits. The uncorrected and corrected distance visual acuities were recorded at each visit. An infrared slitlamp photograph was captured and analyzed to verify the presence of interlenticular membrane formation.

RESULTS

Sixty eyes of 58 patients were analyzed. The mean uncorrected and corrected distance visual acuities improved from logarithm of the minimum angle of resolution 1.34 ± 0.338 and 0.57 ± 0.145 preoperatively to 0.14 ± 0.012 (P < .001) and 0.12 ± 0.008 (P = .001) at 1 year postoperatively, respectively. A mild pinhole decentration was noted in 5 eyes (8.3%). Interlenticular opacification (ILO) was not noted in any patient.

CONCLUSIONS

Implantation of the XtraFocus IOPH inside the capsular bag was a safe technique. Improvement observed in both uncorrected and corrected distance visual acuities was significant and sustained over time. ILO did not occur when this implant was positioned in the capsular bag together with a primary IOL.