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Completed

NCT Number: NCT04557579

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

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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Key information

Conditions

Intraocular Lens

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Taipei Nobel Eye Clinic

Taipei, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clear corneal phacoemulsification and IOL implantation

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).

Primary outcomes

  1. Ophthalmic examinations

    Time frame: 1 month after surgery.

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

  2. Wavefront examination

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Taipei Nobel Eye Clinic

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 21, 2020
Registry last updated
Sep 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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