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Clinical Trials/NCT03586271
NCT03586271
Unknown
Not Applicable

Comparison of the Visual Performance After Implantation of a Trifocal Intraocular Lens(AT Lisa Tri 839MP) and Two Bifocal Intraocular Lenses(ReSTOR +2.5/+ 3.0D and Diff-aay)

Aier School of Ophthalmology, Central South University1 site in 1 country60 target enrollmentAugust 2, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intraocular Lens
Sponsor
Aier School of Ophthalmology, Central South University
Enrollment
60
Locations
1
Primary Endpoint
Uncorrected intermediate visual acuity
Last Updated
7 years ago

Overview

Brief Summary

This is a prospective, consecutive, nonrandomized,comparative study. Comparison of the Visual Performance After Implantation of a Trifocal Intraocular Lens and Two Bifocal Intraocular Lenses

Detailed Description

Multifocal intraocular lenses were introduced in the 1980s and have the benefit of promoting near and far vision simultaneous. However, these multifocal lenses have the disadvantages, including lower contrast sensitivity(CS) and visual discomfort, such as halos, glares and starburst, et al. Therefore, careful patient selection is crucial to achieve good postoperative results. The purpose of this study was to compare the visual outcomes and subjective visual quality between bifocal intraocular Lens(ReSTOR +2.5/+ 3.0D and Diff-aay) and trifocal intraocular Lens(AT Lisa tri 839MP). This prospective, nonrandomized, consecutive, comparative study included the assessment of 60 patients implanted with multifocal intraocular lens. visual acuity was tested in all cases. Ophthalmological evaluation included the measurement of uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), uncorrected near visual acuity (UNVA), and uncorrected intermediate visual acuity (UIVA), the analysis of contrast sensitivity (CS), visual defocus curve, spectacle independence, patient satisfaction, residual sphere, spherical equivalent (SE), cylinder and complications.

Registry
clinicaltrials.gov
Start Date
August 2, 2018
End Date
February 1, 2019
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Aier School of Ophthalmology, Central South University
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • existence of any corneal disease;
  • previous eye surgery;
  • illiteracy;
  • previous refractive surgery;
  • expected postoperative corneal astigmatism more than 1.00D;
  • higer-order aberration more than 0.3;
  • spherical aberration more than 0.3μm;
  • intraoperative or postoperative complications.

Outcomes

Primary Outcomes

Uncorrected intermediate visual acuity

Time Frame: 3 months after surgery

Uncorrected intermediate visual acuity (60cm) were measured using the reading table model of the Early Treatment Diabetic Retinopathy Study charts (ETDRS; Vector Vision, Ltd, Greenville, OH, USA).

Uncorrected distance visual acuity

Time Frame: 3 months after surgery

Uncorrected distance visual acuity (4m) were measured using the reading table model of the Early Treatment Diabetic Retinopathy Study charts (ETDRS; Vector Vision, Ltd, Greenville, OH, USA).

Uncorrected near visual acuity

Time Frame: 3 months after surgery

Uncorrected near visual acuity (40cm) were measured using the reading table model of the Early Treatment Diabetic Retinopathy Study charts (ETDRS; Vector Vision, Ltd, Greenville, OH, USA).

Study Sites (1)

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