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

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

Detailed Description
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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.

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

Conditions
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Intraocular Lens

Intervention / Treatment
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* Procedure: Clear corneal phacoemulsification and IOL implantation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Bifocal group<br>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<br>* 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).<br>|
| Extended depth of focus group<br>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<br>* 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).<br>|
| Monofocal group<br>Patients in monofocal group implanted with Sensar AR40e IOL (AMO, Santa Ana, CA, USA) in bilateral eyes | Procedure: Clear corneal phacoemulsification and IOL implantation<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |