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

Primary Purpose

Cataract, Age-Related

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
angle kappa based SBL-3 implantation
0 to 180 degree SBL-3 implantation
Sponsored by
Peking University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract, Age-Related focused on measuring Multifocal Intraocular Lenses, visual acuity, kappa angle

Eligibility Criteria

54 Years - 81 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Peking University Third Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

control group

design group

Arm 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.

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.

Outcomes

Primary Outcome Measures

Uncorrected visual acuity
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 Outcome Measures

Optical quality
An OPD scan III aberrometer (NIDEK Co. Ltd., Gamagori, Japan) was used to evaluate postoperative mesopic and photopic pupil diameters and the quality of vision in each subject. Visual acuity was evaluated by MTF(modulation transfer function), SR(strehl ratio), intraocular total aberration, high order aberration, spherical aberration, coma aberration, trefoil aberration under 4mm pupil diameter.
Contrast sensitivity
Contrast sensitivity measures were conducted uniocularly, under photopic, mesopic (5 cd/m2), photopic with glare and mesopic with glare conditions, with the OPTEC 6500 contrast sensitivity test (Stereo Optical, USA). Contrast sensitivity was evaluated at five spatial frequencies (1.5, 3, 6, 12, and 18 cycles per degree [cpd]). Patients were allowed 5 minutes to adapt to each illumination level before testing.
Defocus curve
Monocular defocus curves were obtained in all patients, positioned at 5m under photopic (>85 cd/m 2 ) condition to measure the visual acuity with each defocus lens, representing the consecutive visual function of each eye. Negative lenses were added in 0.50 D steps and the visual acuity was recorded for each type of defocus level. The procedure was then repeated but with positive lenses. The range of defocus evaluated was from -4.00D to +2.00D.

Full Information

First Posted
September 13, 2018
Last Updated
August 3, 2022
Sponsor
Peking University Third Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03674840
Brief Title
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

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
June 12, 2017 (Actual)
Primary Completion Date
February 1, 2019 (Actual)
Study Completion Date
April 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University Third Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Age-Related
Keywords
Multifocal Intraocular Lenses, visual acuity, kappa angle

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Other
Arm 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.
Arm Title
design group
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
angle kappa based SBL-3 implantation
Intervention Description
SBL-3 implantation based on kappa angle guided by Callisto Eye System(Carl Zeiss Meditec, Germany) intraoperatively.
Intervention Type
Procedure
Intervention Name(s)
0 to 180 degree SBL-3 implantation
Intervention Description
SBL-3 implantation in the direction of 0 to 180 degree guided by Callisto Eye System(Carl Zeiss Meditec, Germany) intraoperatively.
Primary Outcome Measure Information:
Title
Uncorrected visual acuity
Description
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.
Time Frame
3 months postoperatively
Secondary Outcome Measure Information:
Title
Optical quality
Description
An OPD scan III aberrometer (NIDEK Co. Ltd., Gamagori, Japan) was used to evaluate postoperative mesopic and photopic pupil diameters and the quality of vision in each subject. Visual acuity was evaluated by MTF(modulation transfer function), SR(strehl ratio), intraocular total aberration, high order aberration, spherical aberration, coma aberration, trefoil aberration under 4mm pupil diameter.
Time Frame
3 months postoperatively
Title
Contrast sensitivity
Description
Contrast sensitivity measures were conducted uniocularly, under photopic, mesopic (5 cd/m2), photopic with glare and mesopic with glare conditions, with the OPTEC 6500 contrast sensitivity test (Stereo Optical, USA). Contrast sensitivity was evaluated at five spatial frequencies (1.5, 3, 6, 12, and 18 cycles per degree [cpd]). Patients were allowed 5 minutes to adapt to each illumination level before testing.
Time Frame
3 months postoperatively
Title
Defocus curve
Description
Monocular defocus curves were obtained in all patients, positioned at 5m under photopic (>85 cd/m 2 ) condition to measure the visual acuity with each defocus lens, representing the consecutive visual function of each eye. Negative lenses were added in 0.50 D steps and the visual acuity was recorded for each type of defocus level. The procedure was then repeated but with positive lenses. The range of defocus evaluated was from -4.00D to +2.00D.
Time Frame
3 months postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
54 Years
Maximum Age & Unit of Time
81 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hong Qi
Organizational Affiliation
Peking University Third Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China

12. IPD Sharing Statement

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

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