Correction of high myopia with a phakic intraocular lens: interim analysis of clinical and patient-reported outcomes

Abstract

Purpose: To assess uncorrected distance visual acuity (UDVA) and patient-reported outcome changes after bilateral anterior chamber angle-fixated phakic intraocular lens (pIOL) implantation for high myopia.

Setting: Multiple North American surgical centers.

Design: Nonrandomized multicenter clinical trials.

Methods: This was a pooled interim analysis of 2 open-label single-arm studies of high myopia patients with bilateral anterior chamber angle-fixated pIOLs. Assessments compared baseline with 6-month, 1-year, and 2-year measurements. Outcomes included binocular UDVA, binocular corrected distance visual acuity (CDVA), satisfaction with vision, spectacle independence, and Refractive Status and Vision Profile (RSVP) questionnaire results.

Results: One hundred thirty-eight patients (mean age 37 years, 67% women) completed all 4 assessments. The UDVA at 6 months, 1 year, and 2 years postoperatively was statistically better than the baseline CDVA (0.12 logMAR, 0.11 logMAR, 0.12 logMAR, respectively, versus 0.06 logMAR) (P<.005). The increase in preoperative to postoperative satisfaction with uncorrected vision was significant (P<.0001). Distance vision spectacle independence improved from 0% preoperatively to 94% postoperatively (P<.0001). Patients reported significant improvements in the RSVP overall score (P<.0001) and the following 7 subscales: concern with vision (P<.0001), driving (P<.001), problems with glare (P<.05), optical problems (P ≤.001), physical/social functioning (P<.0001), problems with corrective lenses (P<.005), and ocular symptoms (P<.0001).

Conclusions: After pIOL implantation, the UDVA was better than the preoperative CDVA and most patients required no distance vision correction, had improved satisfaction with uncorrected vision, and had improved vision-related quality of life.