Long-term With a Trifocal Intraocular Lens

Sponsor

Qvision, Ophthalmology Department (Other)

Overall Status

Completed

CT.gov ID

NCT04861909

Collaborator

Carl Zeiss Meditec AG (Industry)

Enrollment

Location

2.3

Actual Duration (Months)

16.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cataract	Device: AT LISA tri 839MP

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.

Study Design

Study Type:

Observational

Actual Enrollment :

37 participants

Observational Model:

Other

Time Perspective:

Cross-Sectional

Official Title:

Long-term Efficacy, Visual Performance and Patient Reported Outcomes With a Trifocal Intraocular Lens: Six-year Follow-up

Actual Study Start Date :

Sep 15, 2020

Actual Primary Completion Date :

Nov 24, 2020

Actual Study Completion Date :

Nov 24, 2020

Arms and Interventions

Arm	Intervention/Treatment
AT LISA tri 839MP Patients implanted with AT LISA tri 839MP	Device: AT LISA tri 839MP Non interventional study

Arm

Intervention/Treatment

AT LISA tri 839MP

Patients implanted with AT LISA tri 839MP

Device: AT LISA tri 839MP

Non interventional study

Outcome Measures

Primary Outcome Measures

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

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.
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)
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
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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 Criteria:

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.