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

doi:10.3969/j.issn.2095-4344.2016.47.021

Abstract

Abstract:

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.
OBJECTIVE: 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 function.
METHODS: 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). This study protocol has been approved by the Medical Ethics Committee of Qinghai University Affiliated Hospital in China (approval No. QHY1107K) and will be performed in accordance with the guidelines of the Declaration of Helsinki, formulated by the World Medical Association. Signed informed consent regarding trial procedure and treatment will be obtained from each patient or their guardians. This trial was registered at ClinicalTrials.gov (NCT02696496).
RESULTS AND CONCLUSION: The primary outcome of the trial is to investigate the biocompatibility of the IOL after implantation. The secondary outcomes include visual acuity, refractive changes and the presence of any complications. Outcome measures will be evaluated at 1, 3, 6, 12 and 24 months after IOL implantation. It is anticipated that the data collected from this trial will provide evidence for IOL selection in senile cataract patients.

中国组织工程研究杂志出版内容重点：生物材料；骨生物材料; 口腔生物材料; 纳米材料; 缓释材料; 材料相容性；组织工程

Key words: Clinical Trial, Lenses, Intraocular, Lens, Crystalline, Cataract, Aged, Randomized Controlled Trial

CLC Number:

R318

Yu Ping, Wang Qing, Liu Ling-ling. Safety and efficacy of implantation of two multifocal intraocular lenses in the treatment of senile cataract: study protocol for a randomized controlled clinical trial[J]. Chinese Journal of Tissue Engineering Research, 2016, 20(47): 7139-7144.

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