Visual Performance of Different Types of Functional Intraocular Lenses in Cataract Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 62
- Locations
- 1
- Primary Endpoint
- uncorrected intermediate visual acuity (UIVA)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
uncorrected intermediate visual acuity (UIVA)
Time Frame: one year
uncorrected visual acuity at 60 cm
best corrected distance visual acuity (BCVA)
Time Frame: one year
corrected visual acuity at 5 m
uncorrected near visual acuity (UNVA)
Time Frame: one year
uncorrected visual acuity at 40 cm
uncorrected distance visual acuity (UDVA)
Time Frame: one year
uncorrected visual acuity at 5 m
Secondary Outcomes
- HOAs(three months)
- Strehl Ratio(three months)
- objective visual quality(three months)