Clinical trial NCT04861909: Long-term With a Trifocal Intraocular Lens
Official title: Long-term Efficacy, Visual Performance and Patient Reported Outcomes With a Trifocal Intraocular Lens: Six-year Follow-up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Keywords: Multifocal intraocular lens
Long-term
Safety
Efficacy
Defocus curve
Light distortion
Lead sponsor: Qvision, Ophthalmology Department
Sponsor class: OTHER
Collaborators: name: Carl Zeiss Meditec AG
First posted: 2021-04-27
Enrollment: 37
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients implanted with AT Lisa Tri from March 2014 to June 2015

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Monocular visual acuity
timeFrame: 6 years
Secondary outcomes:
measure: Contrast sensitivity defocus curve in logCS
timeFrame: 6 years
measure: Light distortion analysis in percentage
timeFrame: 6 years
measure: Visual Function Questionnaire (VF-14)
timeFrame: 6 years
measure: Patient-Reported Spectacle Independence Questionnaire (PRSIQ)
timeFrame: 6 years
measure: Satisfaction, Photic Phenomena and Operated again
timeFrame: 6 years
Other outcomes:
Locations:
city: Almería
country: Spain
facility: Qvision, Vithas Virgen del Mar Hospital
Study officials:
References: