Safety and efficacy of two multifocal intraocular lenses in the treatment of senile cataract: study protocol for a randomized controlled trial

Background: Phacoemulsification with intraocular lens (IOL) implantation has become a well-established treatment for senile cataract. The ideal IOL is characterized by good biocompatibility and resolution, with no spherical aberration. The Acri.LISA 366D is a refractive/diffractive multifocal IOL that differs from traditional multifocal IOLs. Its unique optical design can improve the patient′s vision and reduce incident ray scattering, glare and halo. The goal of this study is to perform a comparative analysis between the Acri.LISA 366D and the Tecnis Z9001 diffractive multifocal IOL, to determine if there are any differences in biocompatibility and improvement in visual acuity. Methods/Design: A prospective, single-center, randomized, double-blind, parallel-controlled study will be conducted at the Affiliated Hospital of Qinghai University in China. Forty cataract patients aged 50-80 years will be randomly assigned to either the Acri.LISA 366D or Tecnis Z9001 IOL (n = 20 per group). The primary outcome of the trial is to investigate the biocompatibility of the IOL after implantation. The secondary outcome is the best corrected visual acuity. Outcome measures will be evaluated at 1, 3, 6 months, 1, 2 years after IOL implantation. Discussion: It is anticipated that the data collected from this trial will provide evidence for IOL selection in senile cataract patients. Trial registration: ClinicalTrials.gov identifier: NCT02966496; registered on 9 November 2016. Ethics: This trial has been approved by the Ethics Committee, Affiliated Hospital of Qinghai University, China (approval number: QHY1107K) and will be performed in accordance with the Declaration of Helsinki, formulated by the World Medical Association. Informed consent: Signed informed consent will be obtained from the patients or their guardians