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Comparison of the Visual Performance After Implantation of Multifocal Lens

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ClinicalTrials.gov Identifier: NCT03586271
Recruitment Status : Recruiting
First Posted : July 13, 2018
Last Update Posted : July 13, 2018
Sponsor:
Information provided by (Responsible Party):
Aier School of Ophthalmology, Central South University

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

Condition or disease Intervention/treatment
Intraocular Lens Procedure: trifocal lens Procedure: bifocal lens 1 Procedure: bifocal lens 2 Procedure: bifocal lens 3

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.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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)
Estimated Study Start Date : August 2, 2018
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : February 1, 2019

Group/Cohort Intervention/treatment
trifocal lens
trifocal lens implantation(AT Lisa tri 839MP)
Procedure: bifocal lens 1
phacoemusification +bifocal lens(Diff-aay) implantation

Procedure: bifocal lens 2
phacoemusification +bifocal lens (ReSTOR +3.0D) implantation

Procedure: bifocal lens 3
phacoemusification +bifocal lens (ReSTOR +2.5D) implantation

bifocal lens 1
bifocal lens implantation(Diff-aay)
Procedure: trifocal lens
phacoemusification + trifocal lens(AT Lisa tri 839MP) implantation

Procedure: bifocal lens 2
phacoemusification +bifocal lens (ReSTOR +3.0D) implantation

Procedure: bifocal lens 3
phacoemusification +bifocal lens (ReSTOR +2.5D) implantation

bifocal lens 2
bifocal lens implantation(ReSTOR +3.0D)
Procedure: trifocal lens
phacoemusification + trifocal lens(AT Lisa tri 839MP) implantation

Procedure: bifocal lens 1
phacoemusification +bifocal lens(Diff-aay) implantation

Procedure: bifocal lens 3
phacoemusification +bifocal lens (ReSTOR +2.5D) implantation

bifocal lens 3
bifocal lens implantation(ReSTOR +2.5D)
Procedure: trifocal lens
phacoemusification + trifocal lens(AT Lisa tri 839MP) implantation

Procedure: bifocal lens 1
phacoemusification +bifocal lens(Diff-aay) implantation

Procedure: bifocal lens 2
phacoemusification +bifocal lens (ReSTOR +3.0D) implantation




Primary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).


Other Outcome Measures:
  1. Quality of vision [ Time Frame: 3 months after surgery ]
    Quality of vision was measured using the National Eye Institute Visual Function Questionnaire (NEI VFQ)-25. The NEI-VFQ was developed at the RAND under the sponsorship of the NEI; it provides a self-reported measure of visual function.



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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
cataract patients
Criteria

Inclusion Criteria:

  • cataract

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03586271


Contacts
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Contact: Hua Fan +8618988761617 ext +8618988761617 fanhua1116@163.com
Contact: Wensheng Li +8618650424985 ext +8618650424985 drlws@qq.com

Locations
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China
Wensheng Li Recruiting
Shanghai, China, 200000
Contact: Hua Fan    +8618988761617 ext +8618650424985    fanhua1116@163.com   
Contact: Wensheng Li    +8618650424985 ext +8618650424985    drlws@qq.com   
Sponsors and Collaborators
Aier School of Ophthalmology, Central South University
Investigators
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Study Director: Wensheng Li Shanghai Aier Eye Hosptial

Publications:
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Responsible Party: Aier School of Ophthalmology, Central South University
ClinicalTrials.gov Identifier: NCT03586271     History of Changes
Other Study ID Numbers: SHIRB2018016
First Posted: July 13, 2018    Key Record Dates
Last Update Posted: July 13, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: all IPD that underlie results
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: After this study is finished the data will become available for 1year.
Access Criteria: The analytical data will be accessed in published articles.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No