Clinical trial NCT04557579: Comparison of Quality of Vision After Bifocal and Extended Depth of Focus Intraocular Lens Implantation
Official title: Comparison of Quality of Vision After Bifocal and Extended Depth of Focus Intraocular Lens Implantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intraocular Lens
Lead sponsor: Taipei Nobel Eye Clinic
Sponsor class: OTHER
First posted: 2020-09-21
Enrollment: 97
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study was conducted from 2018 to 2020 in the Taipei Nobel Eye Clinic and Universal Eye Center ophthalmology clinic. The research protocol was explained to all prospective participants, after which they provided written informed consent before participating. The study was approved by the Ethics Committee of Chunghua Christian Hospital, and the protocol accorded with the tenets of the Declaration of Helsinki.

Brief summary: To compare the visual performance of the extended depth of focus (EDOF) intraocular lens (IOL) to bifocal and spherical monofocal IOL

Detailed description: This study was conducted from 2018 to 2020. This study included patients who were with presence of cataract in both eyes, age between 50 and 80 years, and corrected distance visual acuity (CDVA) of both eyes under 20/40. Phacoemulsification cataract surgery was arranged for both eyes for all patients. The study groups of IOL models include EDOF Symfony IOL (AMO, Santa Ana, CA, USA), bifocal Restor +2.5D IOL (Alcon, Fort Worth, TX, USA), and monofocal Sensar AR40e IOL (AMO, Santa Ana, CA, USA). The patients were routinely examined preoperatively as well as 1 month after surgery for far and near visual acuity (in LogMAR unit). Contrast sensitivity, wavefront aberration and quality of vision questionnaire was measured at the 1-month postoperative visit. These aforementioned outcomes were recorded and compared between groups.

Eligibility criteria: Inclusion Criteria:

* presence of cataract in both eyes
* age between 50 and 80 years
* CDVA of both eyes under 20/40
* Phacoemulsification cataract surgery was arranged for both eyes

Exclusion Criteria:

* complicated cataract
* corneal opacities or irregularities
* corneal astigmatism \> 1.5 diopter
* dry eye (Schirmer's test I ≤ 5mm)
* amblyopia
* anisometropia
* surgical complications such as posterior capsular bag rupture or vitreous loss
* IOL tilt or decentration
* coexisting ocular pathologies
* glaucoma
* non-dilating pupil
* history of intraocular surgery, laser therapy, or retinopathy
* optic nerve or macular diseases
* refusal or unable to maintain follow-up.

Primary outcomes:
measure: Ophthalmic examinations
timeFrame: 1 month after surgery.
measure: Wavefront examination
timeFrame: at the 1-month postoperative visit
measure: Contrast sensitivity
timeFrame: at the 1-month postoperative visit
measure: Questionnaire
timeFrame: at the 1-month postoperative visit
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Nobel Eye Clinic
Study officials:
affiliation: Taipei Nobel Eye Clinic
name: Chao-Kai Chang, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Calladine D, Evans JR, Shah S, Leyland M. Multifocal versus monofocal intraocular lenses after cataract extraction. Cochrane Database Syst Rev. 2012 Sep 12;(9):CD003169. doi: 10.1002/14651858.CD003169.pub3.
citation: Kohnen T, Nuijts R, Levy P, Haefliger E, Alfonso JF. Visual function after bilateral implantation of apodized diffractive aspheric multifocal intraocular lenses with a +3.0 D addition. J Cataract Refract Surg. 2009 Dec;35(12):2062-9. doi: 10.1016/j.jcrs.2009.08.013.
citation: Thibos LN, Ye M, Zhang X, Bradley A. The chromatic eye: a new reduced-eye model of ocular chromatic aberration in humans. Appl Opt. 1992 Jul 1;31(19):3594-600. doi: 10.1364/AO.31.003594.
citation: Perez-Merino P, Dorronsoro C, Llorente L, Duran S, Jimenez-Alfaro I, Marcos S. In vivo chromatic aberration in eyes implanted with intraocular lenses. Invest Ophthalmol Vis Sci. 2013 Apr 12;54(4):2654-61. doi: 10.1167/iovs.13-11912.
citation: Weeber HA, Piers PA. Theoretical performance of intraocular lenses correcting both spherical and chromatic aberration. J Refract Surg. 2012 Jan;28(1):48-52. doi: 10.3928/1081597X-20111103-01. Epub 2011 Nov 10.
citation: Denoyer A, Le Lez ML, Majzoub S, Pisella PJ. Quality of vision after cataract surgery after Tecnis Z9000 intraocular lens implantation: effect of contrast sensitivity and wavefront aberration improvements on the quality of daily vision. J Cataract Refract Surg. 2007 Feb;33(2):210-6. doi: 10.1016/j.jcrs.2006.10.035.