Visual Outcomes of Functional Intraocular Lenses in Cataracts

Not yet recruiting

• Conditions: Visual Quality; Cataract

• Registration Number: NCT06092164
• Lead Sponsor: Eye & ENT Hospital of Fudan University

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 Timeline

• Status Verified: 2023-10
• Study First Submitted: 2023-10-15
• Study First Submitted QC: 2023-10-15
• Last Update Submitted: 2023-10-19
• Study First Posted: 2023-10-23
• Last Update Posted: 2023-10-23
• Study Start: 2023-12-01
• Primary Completion: 2029-12-30
• Study Completion: 2031-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20000

Inclusion Criteria

• cataract
• age > 18 years

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
uncorrected intermediate visual acuity (UIVA)	one year	uncorrected visual acuity at 60 cm
uncorrected distance visual acuity (UDVA)	one year	uncorrected visual acuity at 5 m
best corrected distance visual acuity (BCVA)	one year	corrected visual acuity at 5 m
uncorrected near visual acuity (UNVA)	one year	uncorrected visual acuity at 40 cm

Secondary Outcome Measures

Name	Time	Method
Strehl Ratio	three months	The derivative of point spread function (PSF)
contrast sensitivity	three months	Contrast sensitivity were obtained from the Functional Vision Analyzer
visual functions	three months	Visual functions were obtained from the OCULUS Binoptometer 4P
HOAs	three months	high order aberrations such as coma
IOL condition	three months	IOL condition were obtained from the wavefront mode of the OPD-Scan III aberrometer.
photic phenomena	three years	Questionnaire of photic phenomena
objective visual quality	three months	The modulation transfer function (MTF) curve
subjective satisfaction	three years	Satisfaction Questionnaire