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

Sponsor
Taipei Nobel Eye Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT04557579
Collaborator
(none)
97
1
12.9
7.5

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Clear corneal phacoemulsification and IOL implantation

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.

Study Design

Study Type:
Observational
Actual Enrollment :
97 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
Comparison of Quality of Vision After Bifocal and Extended Depth of Focus Intraocular Lens Implantation
Actual Study Start Date :
Dec 24, 2018
Actual Primary Completion Date :
Jan 22, 2020
Actual Study Completion Date :
Jan 22, 2020

Arms and Interventions

Arm Intervention/Treatment
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
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

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).

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
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).

Outcome Measures

Primary Outcome Measures

  1. Ophthalmic examinations [1 month after surgery.]

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

  2. Wavefront examination [at the 1-month postoperative visit]

    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.

  3. Contrast sensitivity [at the 1-month postoperative visit]

    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.

  4. Questionnaire [at the 1-month postoperative visit]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Taipei Nobel Eye Clinic Taipei Taiwan

Sponsors and Collaborators

  • Taipei Nobel Eye Clinic

Investigators

  • Principal Investigator: Chao-Kai Chang, Ph.D., Taipei Nobel Eye Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Chao-Kai Chang, Dean, Nobel Eye Institute, Taipei Nobel Eye Clinic
ClinicalTrials.gov Identifier:
NCT04557579
Other Study ID Numbers:
  • 001
First Posted:
Sep 21, 2020
Last Update Posted:
Sep 21, 2020
Last Verified:
Sep 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Sep 21, 2020