Back to resultsComparative Study of Two Multifocal Intraocular Lens With Different Add Power
Primary Purpose
Cataract
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
+2.75 diopters multifocal intraocular lens
+3.25 diopters multifocal intraocular lens
Sponsored by
About this trial
This is an interventional treatment trial for Cataract
Eligibility Criteria
Inclusion Criteria:
- age >= 18
- cataract patients with lens opacities classification higher than grade III
- patients who desire to be spectacle indepence for distance and near vision
Exclusion Criteria:
- previous ocular surgery or trauma
- presence of corneal opacities
- fundus abnormalities
- glaucoma
- uveitis
- amblyopia
- systemic disease
- posterior capsule rupture during cataract surgery
Sites / Locations
- Institute of Vision Research, Department of Ophthalmology, Yonsei University College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
2.75 group
3.25 group
Arm Description
Patients with 2.75 diopters multifocal intraocular lens
Patients with +3.25 diopters multifocal intraocular lens
Outcomes
Primary Outcome Measures
Visual Acuity
Uncorrected distance visual acuity and uncorrected near visual acuity
Secondary Outcome Measures
Contrast sensitivity measured by the Functional Acuity Contrast Test (FACT) of the Optec 6500 view-in test system
Internal aberrations measured by the ray-tracing aberrometer and contrast sensitivity measured by the Functional Acuity Contrast Test (FACT) of the Optec 6500 view-in test system
internal aberration measured by the ray-tracing aberrometer
Internal aberrations measured by the ray-tracing aberrometer and contrast sensitivity measured by the Functional Acuity Contrast Test (FACT) of the Optec 6500 view-in test system
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02424162
Brief Title
Comparative Study of Two Multifocal Intraocular Lens With Different Add Power
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
November 11, 2014 (undefined)
Primary Completion Date
November 3, 2015 (Actual)
Study Completion Date
November 3, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will compare cataract patients with implantation of diffractive multifocal IOL with an additional power of +2.75 diopters (Group 1) and with +3.25 diopters (Group 2). Evaluations will be performed 1 and 3 months following cataract surgery, including measurement of uncorrected distance visual acuity (UDVA), refractive error (manifest refraction [MR]), and uncorrected near visual acuity (UNVA) at 33, 40, and 50 cm. At 3 months, internal aberrations and contrast sensitivity will be evaluated and subjects will complete a questionnaire on outcomes satisfaction, visual symptoms, and spectacle use.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2.75 group
Arm Type
Experimental
Arm Description
Patients with 2.75 diopters multifocal intraocular lens
Arm Title
3.25 group
Arm Type
Active Comparator
Arm Description
Patients with +3.25 diopters multifocal intraocular lens
Intervention Type
Device
Intervention Name(s)
+2.75 diopters multifocal intraocular lens
Intervention Type
Device
Intervention Name(s)
+3.25 diopters multifocal intraocular lens
Primary Outcome Measure Information:
Title
Visual Acuity
Description
Uncorrected distance visual acuity and uncorrected near visual acuity
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Contrast sensitivity measured by the Functional Acuity Contrast Test (FACT) of the Optec 6500 view-in test system
Description
Internal aberrations measured by the ray-tracing aberrometer and contrast sensitivity measured by the Functional Acuity Contrast Test (FACT) of the Optec 6500 view-in test system
Time Frame
3 months
Title
internal aberration measured by the ray-tracing aberrometer
Description
Internal aberrations measured by the ray-tracing aberrometer and contrast sensitivity measured by the Functional Acuity Contrast Test (FACT) of the Optec 6500 view-in test system
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age >= 18
cataract patients with lens opacities classification higher than grade III
patients who desire to be spectacle indepence for distance and near vision
Exclusion Criteria:
previous ocular surgery or trauma
presence of corneal opacities
fundus abnormalities
glaucoma
uveitis
amblyopia
systemic disease
posterior capsule rupture during cataract surgery
Facility Information:
Facility Name
Institute of Vision Research, Department of Ophthalmology, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
102-752
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Comparative Study of Two Multifocal Intraocular Lens With Different Add Power
We'll reach out to this number within 24 hrs