Visual Performance of Functional Intraocular Lenses in Cataracts

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05581888
• Other study ID #: Functional IOLs in cataracts
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 1, 2020
• Est. completion date: March 31, 2023

Study information

• Verified date: November 2022
• Source: Eye & ENT Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective, multi-center, randomized comparative study. The purpose of the study is to evaluate and compare the postoperative visual outcomes and quality of vision of two diffractive trifocal intraocular lenses (IOLs) in patients with high myopic cataracts.

Description:

Binocular implantation of two types of trifocal IOLs was performed in patients with high myopic cataracts. Postoperative uncorrected distance (UNVA), intermediate (UIVA), near (UNVA), and best-corrected distance visual acuity (BCVA) were measured. Defocus curve, high-order aberrations, modulation transfer function curve, Strehl ratio and reading ability were compared between the two groups. The functional vision and incidence of photic phenomena were surveyed using questionnaires.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 62
• Est. completion date: March 31, 2023
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• required binocular cataract extraction
• age > 21 years
• length of optic axis > 26 mm

Exclusion Criteria:

• irregular corneal astigmatism > 0.3 um;
• 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
• High Myopia

Intervention

Device:
• trifocal intraocular lens
Binocular implantation of two different trifocal intraocular lens in high myopic cataracts

Locations

Country	Name	City	State
China	Eye & ENT Hospital of Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Eye & ENT Hospital of Fudan University

Country where clinical trial is conducted

China, 

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	MTF curves	three months