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Clinical Trials/NCT06092164
NCT06092164Not yet recruitingNot Applicable

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

Eye & ENT Hospital of Fudan University0 sites20,000 target enrollmentStarted: December 1, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
20,000
Primary Endpoint
uncorrected distance visual acuity (UDVA)

Study Overview

Brief Summary

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.

Detailed Description

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."

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Outcomes

Primary Outcomes

uncorrected distance visual acuity (UDVA)

Time Frame: one year

uncorrected visual acuity at 5 m

best corrected distance visual acuity (BCVA)

Time Frame: one year

corrected visual acuity at 5 m

uncorrected intermediate visual acuity (UIVA)

Time Frame: one year

uncorrected visual acuity at 60 cm

uncorrected near visual acuity (UNVA)

Time Frame: one year

uncorrected visual acuity at 40 cm

Secondary Outcomes

  • Strehl Ratio(three months)
  • contrast sensitivity(three months)
  • visual functions(three months)
  • HOAs(three months)
  • IOL condition(three months)
  • photic phenomena(three years)
  • objective visual quality(three months)
  • subjective satisfaction(three years)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jin Yang

Professor

Eye & ENT Hospital of Fudan University

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