Clinical trial NCT03586271: Comparison of the Visual Performance After Implantation of Multifocal Lens
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)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intraocular Lens
Lead sponsor: Aier School of Ophthalmology, Central South University
Sponsor class: OTHER
First posted: 2018-07-13
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: cataract patients

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.

Eligibility 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.

Primary outcomes:
measure: Uncorrected distance visual acuity
timeFrame: 3 months after surgery
measure: Uncorrected near visual acuity
timeFrame: 3 months after surgery
measure: Uncorrected intermediate visual acuity
timeFrame: 3 months after surgery
Secondary outcomes:
Other outcomes:
measure: Quality of vision
timeFrame: 3 months after surgery
Locations:
city: Shanghai
country: China
facility: Wensheng Li
Study officials:
affiliation: Shanghai Aier Eye Hosptial
name: Wensheng Li
role: STUDY_DIRECTOR
References:
citation: de Medeiros AL, de Araujo Rolim AG, Motta AFP, Ventura BV, Vilar C, Chaves MAPD, Carricondo PC, Hida WT. Comparison of visual outcomes after bilateral implantation of a diffractive trifocal intraocular lens and blended implantation of an extended depth of focus intraocular lens with a diffractive bifocal intraocular lens. Clin Ophthalmol. 2017 Oct 26;11:1911-1916. doi: 10.2147/OPTH.S145945. eCollection 2017.
citation: Gundersen KG, Potvin R. Comparison of visual outcomes after implantation of diffractive trifocal toric intraocular lens and a diffractive apodized bifocal toric intraocular lens. Clin Ophthalmol. 2016 Mar 17;10:455-61. doi: 10.2147/OPTH.S103375. eCollection 2016.
citation: Xu Z, Cao D, Chen X, Wu S, Wang X, Wu Q. Comparison of clinical performance between trifocal and bifocal intraocular lenses: A meta-analysis. PLoS One. 2017 Oct 26;12(10):e0186522. doi: 10.1371/journal.pone.0186522. eCollection 2017.