Fluid-Filled Injectable Accommodating IOL: 12- to 18-Month Clinical Follow-up
To present 12 and 18 month clinical results a new accommodating intraocular lens, consisting of a hollow, fluid-filled hydrophobic acrylic optic and oversized, hollow, fluid-filled haptics that maintains stable performance when implanted in the capsular bag.
Twenty-six patients were enrolled in this prospective, single-arm study of the FluidVision AIOL (PowerVision, Inc.). Typical IOL study inclusion and exclusion criteria were employed. Performance was assessed by distance, intermediate and near visual acuity, manifest and cycloplegic refraction, objective and subjective accommodative amplitude and contrast sensitivity. Follow-up points which included some or all of these measures were at 3, 6, 12 and 18 months.
The average monocular visual acuities at 12 months (n=24) were: BCDVA was -0.02 logMAR (SD = 0.06), BDCIVA was 0.09 logMAR (SD=0.08) and BDCNVA was 0.25 logMAR (SD=0.09). At 18 months (n=10) the average BCDVA was -0.03 logMAR (SD=0.05), BDCIVA was 0.08 logMAR (SD=0.05) and BDVNVA was 0.25 logMAR (SD=0.06). ). Accommodative amplitude by defocus was 2 and 5 diopters at 12 months with no significant change at 18 months. Early binocular data indicate a >1 line improvement in BDCNVA and a >1 D increase in accommodative amplitude. Mesopic contrast sensitivity was equal to a monofocal TECNIS lens.
All patients received good to excellent visual acuity at distance, intermediate and near. There was no significant change in monocular visual acuities or accommodative amplitude from 12 to 18 months. Early bilateral implantation improved VA and accommodative amplitude. There was no decrease of contrast sensitivity compared to a monofocal IOL.