NCT04874376

Brief Summary

Multicentric, retro- / prospective, open-label, observational PMCF study to investigate visual performance, contrast sensitivity and patient satisfaction after mono- or bilateral implantation of Isopure 1.2.3. intraocular lenses following cataract surgery. The study treatment itself is not part of this observational clinical investigation. Only patients that already have been implanted with the device under investigation qualify for this retro- prospective observational clinical study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
109

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

6 active sites

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

First Submitted

Initial submission to the registry

April 29, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 5, 2021

Completed
19 days until next milestone

Study Start

First participant enrolled

May 24, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2022

Completed
Last Updated

July 20, 2022

Status Verified

July 1, 2022

Enrollment Period

8 months

First QC Date

April 29, 2021

Last Update Submit

July 19, 2022

Conditions

CataractLens Opacities

Keywords

Intraocular LensPremiumhydrophobicIOLmonofocal

Outcome Measures

Primary Outcomes (1)

  • monocular Best Corrected Distance Visual Acuity (CDVA) under photopic light conditions on the first implanted eye.

    No statistically significant difference between the monocular CDVA from 4 months follow up visit when compared to the parent IOL (Micropure 1.2.3). A significance level of 0.025 or lower (p \< 0.025) will be considered statistically significant. CDVA is measured with ETDRS charts placed in 4m distance with best aided corrective glasses according to ISO 11979-7:2018.

    From 120 days postoperative

Study Arms (1)

IOL retrospective data collection

EXPERIMENTAL

Experimental arm: Premium Monofocal intraocular lens.

Device: IOL implantation experimental (Isopure 1.2.3.)

Interventions

IOL implantation experimental (Isopure 1.2.3.)DEVICE

Implantation of Premium Monofocal Isopure 12.3 with retrospective data collection

IOL retrospective data collection

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female adults ages 45 years or older on the day of treatment that were mono- or bilaterally implanted with Isopure 1.2.3. intraocular lens minimum 120 days before the study visit;
  • Maximum time between first and second eye treatment: 45 days (this accounts for bilateral implantations only);
  • Capability to understand and sign an IRB approved informed consent form and privacy authorization;
  • Clear intraocular media;
  • Minimum set of retrospective preoperative and intraoperative data available as outlined in the examination matrix;
  • Willing and able to conform to the study requirements.

You may not qualify if:

  • Age of patient \<45 years at the day of surgery;
  • Time between first and second eye treatment: \>45 days (this accounts for bilateral implantations only);
  • Subjects who underwent previous intraocular or corneal surgery other than IOL implantation;
  • Subjects with diagnosed degenerative visual disorders (e.g. AMD or CME);
  • Subjects in whom in-the-bag implantation was not possible;
  • Subjects in whom surgical complications occurred (e.g. posterior rupture).
  • Subjects showing glaucoma;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Oftalvist, Alicante

Alicante, Spain

Location

Vithas, Alicante

Alicante, Spain

Location

Clinica Baviera

Madrid, Spain

Location

HM Monteprincipe

Madrid, Spain

Location

HM Vallés

Madrid, Spain

Location

Augenklinik, Palma de Mallorca

Multiple Locations, Spain

Location

Related Publications (1)

  • Morlock R, Wirth RJ, Tally SR, Garufis C, Heichel CWD. Patient-Reported Spectacle Independence Questionnaire (PRSIQ): Development and Validation. Am J Ophthalmol. 2017 Jun;178:101-114. doi: 10.1016/j.ajo.2017.03.018. Epub 2017 Mar 22.

    PMID: 28341605BACKGROUND

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Gonzalo Bernabeu Arias, MD

    HM Monteprincipe, HM Vallés, Madrid, Spain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2021

First Posted

May 5, 2021

Study Start

May 24, 2021

Primary Completion

January 12, 2022

Study Completion

January 12, 2022

Last Updated

July 20, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

ES(6)