Evaluation of the Visual Acuity After the Implantation of a Tecnis +2.75 Diopters Bifocal Intraocular Lens (Tecnis ZKB00) in the Distance Dominant Eye, in Combination With a +3.25 Diopters Tecnis Bifocal Intraocular Lens (Tecnis ZLB00) in the Fellow Eye.
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Visual acuities in the far, intermediate and near
Study Overview
Brief Summary
The objective of this study is to assess the visual outcome after the combined binocular implantation of +2.75 D and +3.25 D full-diffractive multifocal intraocular lenses.
Detailed Description
Bifocal multifocal intraocular lenses (MIOL) are effective in achieving good uncorrected visual acuities in the distance and the near. However, the intermediate vision is of increasing relevance for everyday's life. Several multifocal intraocular lenses have been developed to improvement intermediate vision. Nonetheless, those systems still possess adverse photic effects and do not garantuee spectacle independence. Therefore, the combination of a lower-addition bifocal intraocular lense in the distance-dominant eye with a higher-addition bifocal intraocular lense in the fellow-eye might be a promising approach to address these drawbacks of current binocular and trifocal intraocular lenses.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •clinically significant cataract
- •endothelial cell count: patients aged 18-75 years: > 1000 cells/mm2; patients > 75 years: > 750 cells/mm2
- •absence of vision-limiting corneal or retinal comorbidities
- •capability to understand the informed consent
Exclusion Criteria
- •expected postoperative astigmatism > 0.75 diopters
- •irregular astigmatism
- •dilated pupil diameter < 3 mm
- •corneal and fundus abnormalities that might cause visual impairments
- •inability to attend follow-up visits
Outcomes
Primary Outcomes
Visual acuities in the far, intermediate and near
Time Frame: 3 months
Visual acuities are tested under photopic conditions at 5 m, intermediate (80 cm) and patient-preferred near distance (≈ 40 cm).
Mesopic vision
Time Frame: 3 months
Mesopic visual acuities are tested under high-contrast, low-contrast and low-contrast with glare.
Scotopic contrast sensitivity
Time Frame: 3 months
Scotopic contrast sensitivity are tested at 0.1 cd/m2, 0.032 cd/m2 and 0.1 cd/m2 with glare.
Visual acuities in the far, intermediate and near
Time Frame: 1 month
Visual acuities are tested under photopic conditions at 5 m, intermediate (80 cm) and patient-preferred near distance (≈ 40 cm).
Mesopic vision
Time Frame: 1 month
Mesopic visual acuities are tested under high-contrast, low-contrast and low-contrast with glare.
Scotopic contrast sensitivity
Time Frame: 1 month
Scotopic contrast sensitivity are tested at 0.1 cd/m2, 0.032 cd/m2 and 0.1 cd/m2 with glare.
Secondary Outcomes
- Spectacle independence in the far, intermediate and near(3 months)
Investigators
PD Dr. med. Eckart Bertelmann
Senior Consultant
Charite University, Berlin, Germany