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Clinical Trials/NCT03674840
NCT03674840
Completed
Not Applicable

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

Peking University Third Hospital1 site in 1 country40 target enrollmentJune 12, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cataract, Age-Related
Sponsor
Peking University Third Hospital
Enrollment
40
Locations
1
Primary Endpoint
Uncorrected visual acuity
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
June 12, 2017
End Date
April 1, 2019
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hong Qi

Professor

Peking University Third Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Uncorrected visual acuity

Time Frame: 3 months postoperatively

Comparison of uncorrected distance visual acuity (UCVA), intermediate visual acuity, near visual acuity were measured at 5m, 80cm and 33cm respectively. All visual acuity measurements were conducted under photopic conditions (85 cd/m2) and at 100% contrast in design group and control group.

Secondary Outcomes

  • Defocus curve(3 months postoperatively)
  • Optical quality(3 months postoperatively)
  • Contrast sensitivity(3 months postoperatively)

Study Sites (1)

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