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.
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.
Study Type
OBSERVATIONAL
Enrollment
37
Non interventional study
Qvision, Vithas Virgen del Mar Hospital
Almería, Spain
Monocular visual acuity
Visual acuity measured with and without best corrected distance subjective refraction in logMAR scale, lower value meaning better results.
Time frame: 6 years
Contrast sensitivity defocus curve in logCS
Contrast Sensitivity measured at different vergence distances with Multifocal Lens Analyzer (www.defocuscurve.com) in logCS scale, higher value meaning better results.
Time frame: 6 years
Light distortion analysis in percentage
Light Distortion Analyzer (CEORLab, University of Minho, Braga, Portugal) in Percentage, higher percentage meaning poorer results.
Time frame: 6 years
Visual Function Questionnaire (VF-14)
Patient reported outcomes evaluation of difficulties related to visual function in daily life activities (Scale ranging from 0 - 100, higher values meaning better results)
Time frame: 6 years
Patient-Reported Spectacle Independence Questionnaire (PRSIQ)
Patient reported outcomes of spectacle independence showing descriptive results of percentage of patients using need of glasses, often wear and comfortably without wear
Time frame: 6 years
Satisfaction, Photic Phenomena and Operated again
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.
Time frame: 6 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.