NCT04861909

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 24, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 24, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 27, 2021

Completed
Last Updated

April 27, 2021

Status Verified

April 1, 2021

Enrollment Period

2 months

First QC Date

February 19, 2021

Last Update Submit

April 22, 2021

Conditions

Cataract

Keywords

Multifocal intraocular lensLong-termSafetyEfficacyDefocus curveLight distortion

Outcome Measures

Primary Outcomes (1)

  • Monocular visual acuity

    Visual acuity measured with and without best corrected distance subjective refraction in logMAR scale, lower value meaning better results.

    6 years

Secondary Outcomes (5)

  • Contrast sensitivity defocus curve in logCS

    6 years

  • Light distortion analysis in percentage

    6 years

  • Visual Function Questionnaire (VF-14)

    6 years

  • Patient-Reported Spectacle Independence Questionnaire (PRSIQ)

    6 years

  • Satisfaction, Photic Phenomena and Operated again

    6 years

Study Arms (1)

AT LISA tri 839MP

Patients implanted with AT LISA tri 839MP

Device: AT LISA tri 839MP

Interventions

AT LISA tri 839MPDEVICE

Non interventional study

AT LISA tri 839MP

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients implanted with AT Lisa Tri from March 2014 to June 2015

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qvision, Vithas Virgen del Mar Hospital

Almería, 04120, Spain

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2021

First Posted

April 27, 2021

Study Start

September 15, 2020

Primary Completion

November 24, 2020

Study Completion

November 24, 2020

Last Updated

April 27, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)