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

T

Taipei Nobel Eye Clinic

Status

Completed

Conditions

Intraocular Lens

Treatments

Procedure: Clear corneal phacoemulsification and IOL implantation

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Full 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.

Enrollment

97 patients

Sex

All

Ages

50 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

97 participants in 3 patient groups

Bifocal group
Description:
Patients in bifocal group implanted with Restor +2.5D IOL (Alcon, Fort Worth, TX, USA) in bilateral eyes
Treatment:
Procedure: Clear corneal phacoemulsification and IOL implantation
Extended depth of focus group
Description:
Patients in extended depth of focus group implanted with EDOF Symfony IOL (AMO, Santa Ana, CA, USA) in bilateral eyes
Treatment:
Procedure: Clear corneal phacoemulsification and IOL implantation
Monofocal group
Description:
Patients in monofocal group implanted with Sensar AR40e IOL (AMO, Santa Ana, CA, USA) in bilateral eyes
Treatment:
Procedure: Clear corneal phacoemulsification and IOL implantation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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