Visual Outcomes of Functional Intraocular Lenses in Cataracts

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06092164
• Other study ID #: IOL Outcomes in cataracts
• Status: Not yet recruiting
• Start date: December 1, 2023
• Est. completion date: December 30, 2031

Study information

• Verified date: October 2023
• Source: Eye & ENT Hospital of Fudan University
• Contact: Jin Yang
• Phone: +8613671632525
• Email: jin_er76[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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."

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20000
• Est. completion date: December 30, 2031
• Est. primary completion date: December 30, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Visual Quality

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eye & ENT Hospital of Fudan University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	uncorrected distance visual acuity (UDVA)	uncorrected visual acuity at 5 m	one year
Primary	best corrected distance visual acuity (BCVA)	corrected visual acuity at 5 m	one year
Primary	uncorrected near visual acuity (UNVA)	uncorrected visual acuity at 40 cm	one year
Primary	uncorrected intermediate visual acuity (UIVA)	uncorrected visual acuity at 60 cm	one year
Secondary	HOAs	high order aberrations such as coma	three months
Secondary	Strehl Ratio	The derivative of point spread function (PSF)	three months
Secondary	objective visual quality	The modulation transfer function (MTF) curve	three months
Secondary	contrast sensitivity	Contrast sensitivity were obtained from the Functional Vision Analyzer	three months
Secondary	visual functions	Visual functions were obtained from the OCULUS Binoptometer 4P	three months
Secondary	IOL condition	IOL condition were obtained from the wavefront mode of the OPD-Scan III aberrometer.	three months
Secondary	subjective satisfaction	Satisfaction Questionnaire	three years
Secondary	photic phenomena	Questionnaire of photic phenomena	three years