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OpenTrials
Completed

NCT Number: NCT04392024

Clinical Outcome of Extended-depth-of-focus Trifocal Intraocualr Lens (Triumf) Implantation

Clinical outcome of extended-depth-of-focus trifocal intraocualr lens (Triumf) implantation

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Key information

Conditions

Presbyopia Eye Diseases Refractive Errors

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Adult at the age of 21 or older at the time of the pre-operative examination and willing to have surgery on their 2nd eye within 7-28 days of their 1st eye
  • Age-related cataract
  • A patient with preoperative corneal astigmatism from IOL Master less than 1 diopters
  • A patient want presbyopia correction at the same time as cataract surgery
  • A patient has the visual potential of 20/25 or better in each eye after cataract removal and IOL implantation
  • Written informed consent to surgery and participation in the study

Exclusion criteria

  • Those with other diseases that can affect capsule stability such as pseudoexoliation syndrome, glaucoma, traumatic cataract
  • Pregnant woman and lactating woman
  • A patient with history of ocular trauma or ocular surgery (Intraocular surgery, refractive surgery, ocular surface surgery) in either eye
  • A patient with evidence of keratoconus or significant irregular astigmatism on pre-operative topography in either eye
  • If expectations for presbyopia correction are too high
  • Those who are not able to read and understand the informed consent (illiterate or foreigners)

Treatment and study plan

Triumf

Device

Triumf is intraocular lens which offers multifocal vision by extended depth of focus and diffractive optics.

Primary outcomes

  1. Uncorrected distant visual acuity

    Time frame: 3 months

    Visual acuity at distant with bare eyes

  2. Uncorrected near visual acuity

    Time frame: 3 months

    Visual acuity at near with bare eyes

Secondary outcomes

  1. Contrast sensitivity

    Time frame: 3 months

    Ability to recognize figure or letter at different contrast environment

  2. Quality of Vision

    Time frame: 3 months

    Degree of various symptoms associated with vision

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
May 18, 2020
Registry last updated
May 10, 2022

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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