Comparative Study of Two Multifocal Intraocular Lens With Different Add Power
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Yonsei University
- Enrollment
- 43
- Locations
- 1
- Primary Endpoint
- Visual Acuity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •amblyopia
- •systemic disease
- •posterior capsule rupture during cataract surgery
Arms & Interventions
2.75 group
Patients with 2.75 diopters multifocal intraocular lens
Intervention: +2.75 diopters multifocal intraocular lens (Device)
3.25 group
Patients with +3.25 diopters multifocal intraocular lens
Intervention: +3.25 diopters multifocal intraocular lens (Device)
Outcomes
Primary Outcomes
Visual Acuity
Time Frame: 3 months
Uncorrected distance visual acuity and uncorrected near visual acuity
Secondary Outcomes
- Contrast sensitivity measured by the Functional Acuity Contrast Test (FACT) of the Optec 6500 view-in test system(3 months)
- internal aberration measured by the ray-tracing aberrometer(3 months)