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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

97 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-24

Study Completion Date

2020-01-22

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

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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.

Conditions

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Intraocular Lens

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Bifocal group

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

Clear corneal phacoemulsification and IOL implantation

Intervention Type 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).

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

Clear corneal phacoemulsification and IOL implantation

Intervention Type 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).

Monofocal group

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

Clear corneal phacoemulsification and IOL implantation

Intervention Type 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).

Interventions

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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).

Intervention Type PROCEDURE

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.

Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No