Long-term With a Trifocal Intraocular Lens
- Conditions
- Cataract
- Interventions
- Device: AT LISA tri 839MP
- Registration Number
- NCT04861909
- Lead Sponsor
- Qvision, Ophthalmology Department
- 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 secondary aim was to evaluate new metrics such as contrast sensitivity defocus curves and light distortion analysis.
- 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 questionnaires conducted by a phone call in all the patients implanted in our center with AT LISA 839MP from March 2014 to June 2015 (n=92) which accomplished inclusion / exclusion criteria and were able to be contacted by phone (n=62).
The incidence of Nd-YAG capsulotomy was retrospectively evaluated through the revision of the medical history, in patients for which capsulotomy was conducted in our center, or a question, for those treated in another center.
• Study visit:
Second stage included the consecutive invitation of these phone interviewed patients to a visit in our center for a long-term visual performance assessment up to accomplish the required sample size (n=37).
Corrected and uncorrected monocular visual acuities were the primary end-points for testing non-inferiority hypothesis in comparison to 12-month follow-up mean results reported in the literature. Secondary variables of assessment were contrast sensitivity defocus curve and light distortion analysis.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 37
-
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.
-
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description AT LISA tri 839MP AT LISA tri 839MP Patients implanted with AT LISA tri 839MP
- Primary Outcome Measures
Name Time Method Monocular visual acuity 6 years Visual acuity measured with and without best corrected distance subjective refraction in logMAR scale, lower value meaning better results.
- Secondary Outcome Measures
Name Time Method Satisfaction, Photic Phenomena and Operated again 6 years Independent questions not associated with a validated questionnaire showing descriptive results of percentage of patients satisfied with their vision, the bothersome to photic phenomena and the likely to be operated again.
Light distortion analysis in percentage 6 years Light Distortion Analyzer (CEORLab, University of Minho, Braga, Portugal) in Percentage, higher percentage meaning poorer results.
Visual Function Questionnaire (VF-14) 6 years Patient reported outcomes evaluation of difficulties related to visual function in daily life activities (Scale ranging from 0 - 100, higher values meaning better results)
Contrast sensitivity defocus curve in logCS 6 years Contrast Sensitivity measured at different vergence distances with Multifocal Lens Analyzer (www.defocuscurve.com) in logCS scale, higher value meaning better results.
Patient-Reported Spectacle Independence Questionnaire (PRSIQ) 6 years Patient reported outcomes of spectacle independence showing descriptive results of percentage of patients using need of glasses, often wear and comfortably without wear
Trial Locations
- Locations (1)
Qvision, Vithas Virgen del Mar Hospital
🇪🇸Almería, Spain