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NCT Number: NCT06092164

Visual Outcomes of Functional Intraocular Lenses in Cataracts

This is a prospective, multi-center, randomized comparative study. The purpose of the study is to evaluate and compare the objective and subjective visual outcomes of different types of functional intraocular lenses (IOLs) in patients.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases Visual Quality

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

Analyzing the subjective and objective visual outcomes and related factors following the implantation of various types of intraocular lenses（bifocal, trifocal, extended depth of focus (EDOF), and astigmatism-correcting intraocular lenses), exploring the advantages, disadvantages, and suitable patient populations for different types of intraocular lenses, analyzing the factors affecting postoperative visual quality, and providing guidance to better assist patients with diverse needs in clinical settings, aiming to offer multidimensional postoperative visual quality."

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • cataract
  • age > 18 years

Exclusion criteria

  • amblyopia; previous ocular surgery;
  • ocular pathologies such as diabetic retinopathy, macular degeneration, glaucoma with field defects;
  • requirements for further ocular surgery (other than Nd:YAG capsulotomy) or retinal laser treatments during the study

Treatment and study plan

Primary outcomes

  1. uncorrected distance visual acuity (UDVA)

    Time frame: one year

    uncorrected visual acuity at 5 m

  2. best corrected distance visual acuity (BCVA)

    Time frame: one year

    corrected visual acuity at 5 m

  3. uncorrected near visual acuity (UNVA)

    Time frame: one year

    uncorrected visual acuity at 40 cm

  4. uncorrected intermediate visual acuity (UIVA)

    Time frame: one year

    uncorrected visual acuity at 60 cm

Secondary outcomes

  1. HOAs

    Time frame: three months

    high order aberrations such as coma

  2. Strehl Ratio

    Time frame: three months

    The derivative of point spread function (PSF)

  3. objective visual quality

    Time frame: three months

    The modulation transfer function (MTF) curve

  4. contrast sensitivity

    Time frame: three months

    Contrast sensitivity were obtained from the Functional Vision Analyzer

  5. visual functions

    Time frame: three months

    Visual functions were obtained from the OCULUS Binoptometer 4P

  6. IOL condition

    Time frame: three months

    IOL condition were obtained from the wavefront mode of the OPD-Scan III aberrometer.

  7. subjective satisfaction

    Time frame: three years

    Satisfaction Questionnaire

  8. photic phenomena

    Time frame: three years

    Questionnaire of photic phenomena

Study contacts

Contact information is provided by the study sponsor or research team.

Jin Yang

CONTACT

[email protected]

+8613671632525

Sponsors and collaborators

Lead sponsor

Eye & ENT Hospital of Fudan University

Other

Registry information

Official study title

Visual Outcomes of Different Types of Functional Intraocular Lenses in Cataract Patients

Important dates

Study start
2023
Primary completion
2029
Study completion
2031
First posted
Oct 23, 2023
Registry last updated
Oct 23, 2023

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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