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

Peking University

Status: Completed

Conditions: Cataract, Age-Related

Treatments: Procedure: angle kappa based SBL-3 implantation; Procedure: 0 to 180 degree SBL-3 implantation

Study type: Interventional

Funder types: Other

Identifiers

NCT03674840

20180906

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 patients

Sex: All

Ages: 54 to 81 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

control group

Other group

Description:

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.

Treatment:

Procedure: 0 to 180 degree SBL-3 implantation

design group

Experimental group

Description:

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.

Treatment:

Procedure: angle kappa based SBL-3 implantation