Randomised controlled study comparing two monofocal hydrophobic acrylic intraocular lenses: the Clareon® and TECNIS PCB00® – six-month results

Session Details

Session Title: Monofocal IOLs: New Biomaterials & Visual Performance

Session Date/Time: Tuesday 17/09/2019 | 16:30-18:00

Paper Time: 16:30

Venue: Free Paper Forum: Podium 2

First Author: : N.Stanojcic UK

Co Author(s): :    V. Wagh   E. Azan   M. Bhogal   J. Li   C. Hull   D. O'Brart              

Abstract Details

Purpose:

To evaluate 6-month visual and safety outcomes of a 1-year follow-up randomized controlled study comparing two monofocal, aspheric, hydrophobic acrylic intraocular lenses (IOL): the Clareon® (Alcon, Inc.) and the Tecnis PCB00 (Johnson & Johnson Vision, Inc.).

Setting:

King’s College London, St Thomas’ Hospital, London, England

Methods:

136 patients (269 eyes) with cataract and no other ocular or neurological co-morbidities underwent femtosecond laser-assisted cataract surgery and received either the Clareon® or the PCB00 IOL (the same lens in both eyes in bilateral cases) targeting distance emmetropia. Outcome measures included intraoperative complications, logMAR unaided distance visual acuity (UDVA), corrected distance visual acuity (CDVA), spherical equivalent (SE) refraction, rate of posterior capsular opacification (PCO), and incidence/density of glistenings and occurrence of dysphotopsias.

Results:

UDVA was comparable between Clareon(mean±SD;0.04±0.1logMAR) and PCB00 (0.04±0.1logMAR)[P=1.00; 95% confidence interval(CI)-0.02 to 0.02] as was CDVA,Clareon (-0.03±0.07logMAR),PCB00 (-0.02±0.06logMAR)[P=0.21;95%CI-0.03 to 0.01].SE was 0.19 diopters(D)±0.35D for Clareon and 0.19D±0.36 for PCB00(P=1.00;95%CI-0.09 to 0.09).Intraoperative complications were 2.1% for Clareon, 5% for PCB00(P=0.21).PCO rate was 2.9% for Clareon (all had posterior capsular cataracts), 2.2% for PCB00 (P=1.00). One Clareon patient and one PCB00 patient had symptoms of negative dysphotopsias.Glistenings were infrequent in both IOLs, with no median measurements (3 graders) >10 glistenings/mm2 and median Miyata grades of 0, although grades were less with PCB00.

Conclusions:

Six-month visual and safety outcomes of this randomized, controlled study showed no clinical differences between the Clareon® and Tecnis PCB00 IOLs.

Financial Disclosure:

receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented, research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented