Comparison of Optical Quality With Different Placement of Refractive Multifocal Intraocular Lens

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-12

Study Completion Date

2019-04-01

Brief Summary

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The study aims to compare postoperative optical quality between two different implanting position of a rotationally asymmetric MIOL \[SBL-3 Lenstec; +3.00 diopters (D)\], angle kappa based implantation and 0 to 180 degree implantation, in order to find out the optimal implantation position for SBL-3.

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Detailed Description

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SBL-3 has been proved to provide patients with good near, intermediate and distant visual acuity, but there is not much study on the impact of SBL-3 position on postoperative visual acuity.The regional refractive design of SBL-3 means it could be affected by pupil center shift (described by angle kappa: the difference between visual axis and pupil axis), the investigators assume that maintaining the ideal ratio of distant and near segment(50% vs 42%) in the pupil center could yield both good distant and near postoperative visual acuity postoperatively. Therefore, the investigators designed the implantation by placing the IOL based on angle kappa to make sure the ratio of distant and near segment exposure in the pupil center close to 50:42. In this study, the investigators assessed the optical quality in patients with SBL-3 implantation based on angle kappa and 0 to 180 degree to provide surgeons with information for choosing appropriate implantation position for optimum postoperative satisfaction of SBL-3.

Conditions

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Cataract, Age-Related

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment. For each patient one eye was randomly selected as design group and receive a SBL-3 implantation based on angle kappa, while the other eye was included in control group and receive a SBL-3implantation of 0 to 180 degree

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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control group

Subjects in this group will go through a cataract surgery with SBL-3 implantation in the direction of 0 to 180 degree guided by Callisto Eye System(Carl Zeiss Meditec, Germany) intraoperatively.

Group Type OTHER

0 to 180 degree SBL-3 implantation

Intervention Type PROCEDURE

SBL-3 implantation in the direction of 0 to 180 degree guided by Callisto Eye System(Carl Zeiss Meditec, Germany) intraoperatively.

design group

Subjects in this group will go through a cataract surgery with SBL-3 implantation based on kappa angle(described by Pentacam HR preoperatively) guided by Callisto Eye System(Carl Zeiss Meditec, Germany) intraoperatively.

Group Type EXPERIMENTAL

angle kappa based SBL-3 implantation

Intervention Type PROCEDURE

SBL-3 implantation based on kappa angle guided by Callisto Eye System(Carl Zeiss Meditec, Germany) intraoperatively.

Interventions

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angle kappa based SBL-3 implantation

SBL-3 implantation based on kappa angle guided by Callisto Eye System(Carl Zeiss Meditec, Germany) intraoperatively.

Intervention Type PROCEDURE

0 to 180 degree SBL-3 implantation

SBL-3 implantation in the direction of 0 to 180 degree guided by Callisto Eye System(Carl Zeiss Meditec, Germany) intraoperatively.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* age related cataract
* underwent bilateral cataract surgery and SBL-3 implantation
* corneal astigmatism \<1.5D

Exclusion Criteria

* patients with active ocular inflammation
* neuro-ophthalmic disease and macular disease
* previous corneal or intraocular surgery, corneal opacities or disease
* patients had surgical complications, pupillary trauma, inability to place the lens in the capsular bag
* IOL tilt or decentration deviated from intraoperative positioning
* difficulties with examinations and follow-up

Minimum Eligible Age

54 Years

Maximum Eligible Age

81 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No