Comparison of Quality of Vision After Bifocal and Extended Depth of Focus Intraocular Lens Implantation

NCT04557579 | Completed

• 1 other identifier: 001
• Study Type: observational
• Target: 97
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Intraocular Lens

Outcome Measures

Primary Outcomes (4)

• Ophthalmic examinations

  far uncorrected visual acuity(UCVA) and corrected distance visual acuity (CDVA), near UCVA in LogMAR unit

  1 month after surgery.

• Wavefront examination

  Wavefront analysis was performed only at the 1-month postoperative visit with an AMO WaveScan Hartmann-Shack sensor (Santa Clara, CA, USA). The wavefront maps were analyzed using a 6-mm pupil diameter and a Zernike polynomial expansion up to the sixth-order of Zernike coefficients. Higher order aberrations including RMS errors of horizontal coma aberration (Z 3,1), spherical aberration (4,0), trefoil aberration and the higher order aberrations were assessed.

  at the 1-month postoperative visit

• Contrast sensitivity

  CS was also measured at the 1-month postoperative visit using the Vector Vision CSV-1000 (Greenville, OH, USA) chart. All subjects were tested at the recommended distance of 8 feet. The CSV-1000 consists of a series of circular achromatic sine-wave patches having a 1.5-in. diameter and comprising 4 rows, each corresponding to one of 4 spatial frequencies: 3, 6, 12, and 18 cycles per degree (cpd). We selected 3, 6 and 12 cpd for analysis.

  at the 1-month postoperative visit

• Questionnaire

  Subjective QoV was evaluated using a questionnaire adopted from a near-activity 19-item questionnaire and the NEI-RQL-42. Our questionnaire contains 11 questions and the subscales include far vision, diurnal fluctuation, glare and halos, spectacle dependence, near vision, and intermediate vision. In general, questionnaires were completed without assistance; however, on the patient's request, explanations of the questions were provided.

  at the 1-month postoperative visit

Study Arms (3)

Bifocal group

Patients in bifocal group implanted with Restor +2.5D IOL (Alcon, Fort Worth, TX, USA) in bilateral eyes

Procedure: Clear corneal phacoemulsification and IOL implantation

Extended depth of focus group

Patients in extended depth of focus group implanted with EDOF Symfony IOL (AMO, Santa Ana, CA, USA) in bilateral eyes

Procedure: Clear corneal phacoemulsification and IOL implantation

Monofocal group

Patients in monofocal group implanted with Sensar AR40e IOL (AMO, Santa Ana, CA, USA) in bilateral eyes

Procedure: Clear corneal phacoemulsification and IOL implantation

Interventions

Clear corneal phacoemulsification and IOL implantation PROCEDURE

Clear corneal phacoemulsification and IOL implantation were performed by 2 surgeons (Chao-Kai Chang and Hung-Yuan Lin) by using an identical technique to minimize differences in surgically induced aberrations between groups. The surgical process involved topical anesthesia, a 3-step clear corneal incision (2.75 mm) at 180° (temporal in both eyes), a 5.0-mm continuous curvilinear capsulorhexis, phacoemulsification using the stop-and-chop technique, IOL implantation with an injector, IOL centration, and a sutureless incision. The study 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).

Bifocal group; Extended depth of focus group; Monofocal group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Nobel Eye Clinic: lead

Study Sites (1)

Taipei Nobel Eye Clinic

Taipei, Taiwan

Location

Related Publications (6)

• 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.

  PMID: 22972061 BACKGROUND

• 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.

  PMID: 19969209 BACKGROUND

• 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.

  PMID: 20725330 BACKGROUND

• 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.

  PMID: 23493299 BACKGROUND

• 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.

  PMID: 22074466 BACKGROUND

• 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.

  PMID: 17276260 BACKGROUND

Study Officials

• Chao-Kai Chang, Ph.D.

  Taipei Nobel Eye Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean, Nobel Eye Institute

Study Record Dates

• First Submitted: August 27, 2020
• First Posted: September 21, 2020
• Study Start: December 24, 2018
• Primary Completion: January 22, 2020
• Study Completion: January 22, 2020
• Last Updated: September 21, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)