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

NCT03674840 | Completed

• 1 other identifier: 20180906
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract, Age-Related

Keywords

Multifocal Intraocular Lenses; visual acuity; kappa angle

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months postoperatively

Secondary Outcomes (3)

• Optical quality

  3 months postoperatively

• Contrast sensitivity

  3 months postoperatively

• Defocus curve

  3 months postoperatively

Study Arms (2)

control group

OTHER

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.

Procedure: 0 to 180 degree SBL-3 implantation

design group

EXPERIMENTAL

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.

Procedure: angle kappa based SBL-3 implantation

Interventions

angle kappa based SBL-3 implantation PROCEDURE

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

design group

0 to 180 degree SBL-3 implantation PROCEDURE

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

control group

Eligibility Criteria

• Age: 54 Years - 81 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Hong Qi

  Peking University Third Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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

Study Record Dates

• First Submitted: September 13, 2018
• First Posted: September 18, 2018
• Study Start: June 12, 2017
• Primary Completion: February 1, 2019
• Study Completion: April 1, 2019
• Last Updated: August 5, 2022

Record last verified: 2022-08

Locations

CN (1)