Purpose: To compare 5-year outcomes of toric intraocular lens (tIOL) or peripheral corneal relaxing incision (PCRI) for correction of keratometric astigmatism (KA) between 0.75 and 2.5 diopters (D).
Methods: Setting: University Hospital. Design: Randomized clinical trial. Eighty eyes (80 participants) received either tIOL or PCRI. Patients were assessed preoperatively, 1-month, 1, and 5 years. Primary outcomes were uncorrected (UDVA) and best-corrected distance logMAR visual acuity (CDVA). Secondary outcomes were a manifest refractive sphere, refractive astigmatism (Ra), spherical equivalent (SEQ), KA & mean keratometry (KM), and Quality-of-Life Impact of Refractive Correction (QIRC) scores.
Results: There was no difference between the two groups in UDVA, CDVA, refractive sphere, KM, RA, and SEQ. KA reduced after 1 month in the PCRI group and remained stable until 5 years. From 1 to 5 years, the number of eyes with distance emmetropia (within ±0.13D) changed from 59% (20/34 eyes) to 32% (6/19 eyes) for tIOLs and from 43% (15/36 eyes) to 20% (4/21 eyes) for PCRIs with 32% (6/19 eyes) and 20% (4/21 eyes) showing >0.5D change in SEQ at 5-years respectively. Compared to 1-year, Ra significantly increased at 5 years in both groups with no difference between the groups. Mean overall QIRC scores were not different between the groups (tIOL: 49.88 ± 7.47; PCRI: 52.09 ± 7.02; p = .18).
Conclusions: Although there was no difference between the overall visual and vision-related quality of life outcomes between tIOLs and PCRIs, an increase in refractive astigmatism and reduction in distance emmetropia with time was noted in both groups.
Keywords: Astigmatism; ClinicalTrials.gov ID: NCT02067429; intraocular lens; relaxing incision; toric.