Prospective Randomized Single-Masked Study of Bilateral Isofocal Optic-Design or Monofocal Intraocular Lenses
Abstract
PURPOSE: To assess refractive and visual outcomes of bilateral implantation of an isofocal optic-design intraocular lens (IOL) or a monofocal IOL following cataract surgery. METHODS: A total of 127 patients were recruited into a prospective, single-masked, randomized trial.
Sixty-five patients bilaterally implanted with the Isopure Isofocal IOL and 62 patients with the Micropure Monofocal IOL were followed for 4-6 months. Refraction, monocular and binocular uncorrected-distance-visual acuity, corrected-distance-visual acuity (CDVA), uncorrected-intermediate-visual acuity and distance-corrected-intermediate-visual acuity (DCIVA, 66/80 cm), uncorrected-near-visual acuity, and distance-corrected-near-visual acuity (DCNVA, 40 cm) were evaluated.
Binocular defocus curve, binocular contrast sensitivity (photopic, mesopic with/without glare), and glare and halo phenomena were also measured. RESULTS: 99.23% of eyes were within ±1.00D and 84.62% of eyes within ±0.50D for the Isopure patients and 98.39% and 82.26% for the Micropure patients, respectively.
The mean spherical-equivalent was -0.06 ± 0.36D and 0.10 ± 0.32D for the Isopure and Micropure patients, respectively. 98.5% and 100% of patients implanted with the Isopure and Micropure IOLs showed a cumulative binocular CDVA value ≥20/20, respectively. 80% and 67.70% of patients implanted with the Isopure presented a binocular DCIVA ≥20/25 at 80 and 66 cm, respectively. These percentages were 46.8% and 40.3% with the Micropure IOL, respectively.
For Isopure, 7.7%, 30.8%, and 58.5% of patients presented a DCNVA ≥20/25, ≥20/32 and ≥20/40, respectively. These values were lower for the Micropure: 1.6%, 19.4% and 46.8%, respectively.
Defocus curves showed similar good visual acuity at distance for both lenses with better intermediate vision for the Isopure. Both groups presented good contrast sensitivity, and the size and intensity of halo and glare phenomena were similar between the two.
No adverse-events were reported. CONCLUSION: Our trial shows that both IOLs provide excellent visual acuity and contrast sensitivity for far vision with similar photic phenomena, and the Isopure IOL improved unaided intermediate vision performance.