Status:
COMPLETED
Long-term With a Trifocal Intraocular Lens
Lead Sponsor:
Qvision, Ophthalmology Department
Collaborating Sponsors:
Carl Zeiss Meditec AG
Conditions:
Cataract
Eligibility:
All Genders
45-80 years
Brief Summary
The main aims of this study were to evaluate the patient reported outcomes (PROs), safety and efficacy, after 6-year (66 - 78 months) from the binocular implantation of the AT LISA tri 839MP. A second...
Detailed Description
Retrospective cross-sectional study with two stages: • Phone call interview: First stage included patient reported outcomes of visual function, spectacle independence and satisfaction through questi...
Eligibility Criteria
Inclusion
- Phone call interview:
- Patients of either sex, 45 years of age or older at the time of surgery and less than 80 years of age at the time of the phone call.
- Patients implanted bilaterally with the AT LISA 839MP MIOL in the capsular bag.
- No surgical complications reported in the clinical history that could affect postoperative visual acuity: damage to the capsular bag, intraocular hemorrhage, etc.
- Operated between 66 months from the first implanted eye and up to 78 months from the surgery of the second eye
- Patient able to hear, understand and give express consent orally.
- Study visit:
- To have participated in the first stage of the study corresponding to the phone call interview.
- Irregular astigmatism in either eye measured with corneal tomography (total high-order corneal aberrations at 4 mm \< 0.5 μm).
- Patient able to read, understand and provide a written informed consent form.
- Sufficient availability, willingness, skills, and cognitive awareness to comply with follow-up/study procedures and study visits.
Exclusion
- Phone call interview:
- Any eye disease documented in the patient's clinical history that may potentially cause a loss of visual acuity or diplopia: Active or recurrent pathology of the anterior segment (chronic uveitis, iritis, iridocyclitis, rubeosis iridis, uncontrolled glaucoma, etc.), retinal or optic nerve pathologies such as diabetic retinopathy, macular degeneration, etc.
- Eye surgery (including laser refractive surgery) performed before or after the operation with the intraocular lens.
- Study Visit:
- PCO ≥ 2 according to surgeon criteria that produces a loss of CDVA ≥ 0.2 logMAR
- Any eye disorder that can potentially cause a loss of visual acuity or diplopia: Active or recurrent pathology of the anterior segment (chronic uveitis, iritis, iridocyclitis, rubeosis iridis, uncontrolled glaucoma, etc.), retinal or optic nerve pathologies such as diabetic retinopathy, macular degeneration, etc.
- Eye surgery (including laser refractive surgery) performed before or after the operation with the intraocular lens.
- Use of systemic or ocular medications that may affect vision in the last 6 months.
- Subjects who participate in any clinical trial or research with drugs or medical devices within 30 days prior to entry into this research and/or during the period of participation in this research.
Key Trial Info
Start Date :
September 15 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 24 2020
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT04861909
Start Date
September 15 2020
End Date
November 24 2020
Last Update
April 27 2021
Active Locations (1)
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1
Qvision, Vithas Virgen del Mar Hospital
Almería, Spain, 04120