Clinical trial NCT02678962: Comparison of Outcomes With Multifocal Intraocular Lenses
Official title: Comparison of Outcomes With Multifocal Intraocular Lenses
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cataract
Keywords: Multifocal Intraocular Lenses
bilateral implantation
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2016-02-10
Enrollment: 90
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare and evaluate the clinical outcomes of 6 kinds of Multifocal Intraocular Lenses: SN6AD1, SBL-3, LS-313 MF30, AT LISA tri 839 MP, ART, LS-313 MF30T.

Detailed description: This study is a prospective randomized controlled trial to compare and evaluate the clinical outcomes of 6 kinds of Multifocal Intraocular Lenses, the outcome measurements include postoperative visual acuity, visual quality and complications. Patients enrolled in the study will be randomized to receive one of the Multifocal Intraocular Lenses mentioned above, and the clinical outcomes of each Multifocal Intraocular Lens will be assessed at several visits: 1 day, 1 week, 1 month, 3 months and months post-operatively.

Eligibility criteria: Inclusion Criteria:

* Age from 40 to 80 years old, either gender;
* Patients with bilateral age related cataracts, require bilateral cataract phacoemulsification combined Intraocular Lens implantation;
* Willing to undergo second eye surgery within 7 days after first eye surgery;
* The potential postoperative visual acuity of 20/40 or better in both eyes;
* Preoperative measurement of corneal astigmatism indicate the subjects are suitable for multifocal intraocular lenses implantation;
* Capability to understand the informed consent and willing and able to attend study

Exclusion Criteria:

* Preexisting ocular diseases or conditions other than age related cataracts, have contraindications for cataract surgery;
* Preexisting systemic diseases or conditions that may confound the results of the study;
* Previous ocular surgery history or ocular trauma that may confound the results of the study;
* Require combined surgery that may confound the results of the study;
* Previous participation in other clinical trial within 30 days of this study start;
* Systemic or ocular medications that may confound the outcome of the intervention
* Pregnant, lactating, or planning to become pregnant during the course of the trial;

Primary outcomes:
measure: Uncorrected Visual Acuity (UCVA) at Distance, Near
timeFrame: 3 months after surgery
measure: Best distance corrected Visual Acuity at Distance, Near
timeFrame: 3 months after surgery
measure: Defocus curve
timeFrame: 3 months after surgery
measure: Contrast sensitivity
timeFrame: 3 months after surgery
measure: Ocular aberration
timeFrame: 3 months after surgery
measure: Ocular Scatter Index measured by Optical Quality Analysis System(OQAS) II
timeFrame: 3 months after surgery
measure: Modulation Transfer Function (MTF) cut-off measured by OQAS II
timeFrame: 3 months after surgery
measure: Strehl Ratio measured by OQAS II
timeFrame: 3 months after surgery
measure: Quality of Vision (QoV) Questionnaire score
timeFrame: 3 months after surgery
measure: Catquest- 9SF Questionnaire score
timeFrame: 3 months after surgery
Secondary outcomes:
measure: Refractive error after surgery
timeFrame: 3 months after surgery
measure: Rate of Posterior Capsule Opacification
timeFrame: 6 months after surgery
measure: Rate of Nd:YAG Laser Posterior Capsulotomy
timeFrame: 6 months after surgery
measure: Rate of Spectacle Independence
timeFrame: 6 months after surgery
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: The Eye Hispital of Wenzhou Medical University
state: Zhejiang
Study officials:
affiliation: Wenzhou Medical University
name: AYong Yu, MD. PhD.
role: PRINCIPAL_INVESTIGATOR
References: