Clinical trial NCT03674840: Comparison of Optical Quality With Different Placement of Refractive Multifocal Intraocular Lens
Official title: Comparison of Optical Quality With Different Placement of Refractive Multifocal Intraocular Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract, Age-Related
Keywords: Multifocal Intraocular Lenses
visual acuity
kappa angle
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2018-09-18
Enrollment: 40
Sex: ALL
Minimum age (years): 54
Maximum age (years): 81
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

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

Primary outcomes:
measure: Uncorrected visual acuity
timeFrame: 3 months postoperatively
Secondary outcomes:
measure: Optical quality
timeFrame: 3 months postoperatively
measure: Contrast sensitivity
timeFrame: 3 months postoperatively
measure: Defocus curve
timeFrame: 3 months postoperatively
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Hong Qi
role: STUDY_DIRECTOR
References: