Comparison of Horizontal and Vertical IOL Haptic Orientation in Negative Dysphotopsia.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Loma Linda University
- Primary Endpoint
- Presence of negative dysphotopsia after cataract surgery at 6 months
Study Overview
Brief Summary
Previous studies attempted to understand the dysphotopsia phenomenon by examining intraocular lens type, anterior capsule depth, iris-to-lens depth, lens refractive material, clear cornea incision wounds and anterior capsulorrhexis. However, there is limited literature in understanding haptic orientation and negative dysphotopsia; postulated theories and anecdotal reports relate to horizontal haptic orientation and the lateralization of rays such that light is received both in smaller width and anterior to the peripheral retina; however, no formal studies currently exist.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with bilateral cataracts that are visually significant meeting standard criteria for removal and select standard monofocal lens implantation.
Exclusion Criteria
- •Patients with any prior refractive surgery including prior cataract surgery, corneal ocular pathology, iris atrophy/damage, retinal or optic nerve pathology. Patients with history of peripheral vision loss. Patients selecting multifocal or toric lens implantation.
Arms & Interventions
Vertical orientation of Haptic orientation
The orientation of the IOL haptic will be implanted in the vertical position during routine cataract surgery
Intervention: Acrylic lens implantation (Device)
Horizontal orientation of Haptic orientation
The orientation of the IOL haptic will be implanted in the horizontal position during routine cataract surgery
Intervention: Acrylic lens implantation (Device)
Outcomes
Primary Outcomes
Presence of negative dysphotopsia after cataract surgery at 6 months
Time Frame: 6 months
Presence of negative dysphotopsia in the vertical IOL placement compared to horizontal IOL placement
Secondary Outcomes
- Presence of negative dysphotopsia after cataract surgery at 1 week(1 week)
- Presence of negative dysphotopsia after cataract surgery at 1 month(1 month)