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

Intraocular Lens Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04557579
• Other study ID #: 001
• Status: Completed
• Start date: December 24, 2018
• Est. completion date: January 22, 2020

Study information

• Verified date: September 2020
• Source: Taipei Nobel Eye Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: January 22, 2020
• Est. primary completion date: January 22, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Intraocular Lens

Intervention

Procedure:
• Clear corneal phacoemulsification and IOL implantation
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).

Locations

Country	Name	City	State
Taiwan	Taipei Nobel Eye Clinic	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Nobel Eye Clinic

Country where clinical trial is conducted

Taiwan, 

References & 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. Review. Update in: Cochrane Database Syst Rev. 2016 Dec 12;12 :CD003169. — View 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. — View 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. — View Citation

Pérez-Merino P, Dorronsoro C, Llorente L, Durán S, Jiménez-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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ophthalmic examinations	far uncorrected visual acuity(UCVA) and corrected distance visual acuity (CDVA), near UCVA in LogMAR unit	1 month after surgery.
Primary	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
Primary	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
Primary	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