Back to resultsVisual Performance of Functional Intraocular Lenses in Cataracts
Primary Purpose
High Myopia, Cataract
Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
trifocal intraocular lens
Sponsored by
About this trial
This is an interventional treatment trial for High Myopia focused on measuring Visual performance, Trifocal IOL, High myopic cataract
Eligibility Criteria
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
Sites / Locations
- Eye & ENT Hospital of Fudan University
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
839MP group
TFNT00 group
Arm Description
Patients in this group were binocularly implanted with the AT LISA tri 839MP trifocal intraocular lens.
Patients in this group were binocularly implanted with the AcrySof IQ PanOptix TFNT00 trifocal intraocular lens.
Outcomes
Primary Outcome Measures
uncorrected distance visual acuity (UDVA)
uncorrected visual acuity at 5 m
best corrected distance visual acuity (BCVA)
corrected visual acuity at 5 m
uncorrected near visual acuity (UNVA)
uncorrected visual acuity at 40 cm
uncorrected intermediate visual acuity (UIVA)
uncorrected visual acuity at 60 cm
Secondary Outcome Measures
HOAs
high order aberrations such as coma
Strehl Ratio
The derivative of point spread function (PSF)
objective visual quality
MTF curves
Full Information
NCT ID
NCT05581888
First Posted
September 19, 2022
Last Updated
November 1, 2022
Sponsor
Eye & ENT Hospital of Fudan University
1. Study Identification
Unique Protocol Identification Number
NCT05581888
Brief Title
Visual Performance of Functional Intraocular Lenses in Cataracts
Official Title
Visual Performance of Different Types of Functional Intraocular Lenses in Cataract Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
March 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eye & ENT Hospital of Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Myopia, Cataract
Keywords
Visual performance, Trifocal IOL, High myopic cataract
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
839MP group
Arm Type
Other
Arm Description
Patients in this group were binocularly implanted with the AT LISA tri 839MP trifocal intraocular lens.
Arm Title
TFNT00 group
Arm Type
Other
Arm Description
Patients in this group were binocularly implanted with the AcrySof IQ PanOptix TFNT00 trifocal intraocular lens.
Intervention Type
Device
Intervention Name(s)
trifocal intraocular lens
Intervention Description
Binocular implantation of two different trifocal intraocular lens in high myopic cataracts
Primary Outcome Measure Information:
Title
uncorrected distance visual acuity (UDVA)
Description
uncorrected visual acuity at 5 m
Time Frame
one year
Title
best corrected distance visual acuity (BCVA)
Description
corrected visual acuity at 5 m
Time Frame
one year
Title
uncorrected near visual acuity (UNVA)
Description
uncorrected visual acuity at 40 cm
Time Frame
one year
Title
uncorrected intermediate visual acuity (UIVA)
Description
uncorrected visual acuity at 60 cm
Time Frame
one year
Secondary Outcome Measure Information:
Title
HOAs
Description
high order aberrations such as coma
Time Frame
three months
Title
Strehl Ratio
Description
The derivative of point spread function (PSF)
Time Frame
three months
Title
objective visual quality
Description
MTF curves
Time Frame
three months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin Yang
Organizational Affiliation
Department of Ophthalmology, Eye and Ear, Nose, and Throat Hospital, Fudan University
Official's Role
Study Director
Facility Information:
Facility Name
Eye & ENT Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200031
Country
China
12. IPD Sharing Statement
Learn more about this trial
Visual Performance of Functional Intraocular Lenses in Cataracts
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