NCT03423524

Brief Summary

Prospective, non-randomised, open, controlled, single-center post-market clinical follow study about Micropure 1.2.3 IOL.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2018

Typical duration for not_applicable

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

First Submitted

Initial submission to the registry

January 30, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 6, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

May 2, 2018

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 27, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 2021

Completed
Last Updated

February 15, 2022

Status Verified

February 1, 2022

Enrollment Period

3.2 years

First QC Date

January 30, 2018

Last Update Submit

February 14, 2022

Conditions

CataractLens Opacities

Keywords

Intraocular lensMonofocalHydrophobic

Outcome Measures

Primary Outcomes (1)

  • monocular Corrected Distance Visual Acuity (CDVA)

    Statistically non-inferior visual acuity outcomes on monocular Corrected Distance Visual Acuity (CDVA) under photopic light conditions compared to literature data on a monofocal hydrophilic IOL (Bausch \& Lomb - Akreos MI60) at the 3 months follow up visit.

    3 months postoperative

Secondary Outcomes (17)

  • Manifested refraction

    1 month, 3 months, 12 months, 24 months postoperative

  • Monocular and binocular Uncorrected Distance Visual Acuity (UDVA)

    1 month, 3 months, 12 months, 24 months postoperative

  • Monocular and binocular Uncorrected Intermediate Visual Acuity (UIVA)

    1 month, 3 months, 12 months, 24 months postoperative

  • Monocular and binocular Distance Corrected Intermediate Visual Acuity (DCIVA)

    1 month, 3 months, 12 months, 24 months postoperative

  • Binocular Corrected Distance Visual Acuity (CDVA)

    1 month, 3 months, 12 months, 24 months postoperative

  • +12 more secondary outcomes

Other Outcomes (4)

  • Intraocular pressure (IOP) measurement

    Pre-operative, 1 month, 3 months, 12 months, 24 months postoperative

  • Questionnaire on IOL implantation

    peroperative

  • Keratometry

    preoperative

  • +1 more other outcomes

Study Arms (1)

Arm: Investigational Device

EXPERIMENTAL

Implantation of monofocal intraocular lens (IOL) "Micropure 1.2.3." consisting of hydrophobic material

Device: Micropure 1.2.3.

Interventions

Micropure 1.2.3.DEVICE

Implantation of intraocular lens (IOL). Name: "MicroPure 1.2.3." It is a monofocal intraocular lens consisting of hydrophobic acrylic material. One IOL per eye will be implanted

Arm: Investigational Device

Eligibility Criteria

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

You may qualify if:

  • Cataractous eyes with no comorbidity
  • Availability, willingness and sufficient cognitive awareness to comply with examination procedures
  • Signed informed consent

You may not qualify if:

  • Irregular astigmatism
  • Age of patient \< 45 years
  • Regular corneal astigmatism \>0.75 dioptres by an automatic keratometer or biometer or \>1.0 dioptres if the steep axis of cylinder is between 90° and 120°
  • Difficulty for cooperation (distance from their home, general health condition)
  • Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus (with retinopathy), immunocompromised, glaucoma etc…)
  • Any ocular comorbidity
  • History of ocular trauma or prior ocular surgery including refractive procedures
  • Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, chronic Uveitis, Marfan's syndrome)
  • Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions)
  • Complicated surgery
  • Patients who do not give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ophtalmology department - CHU liège

Liège, 4000, Belgium

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Francoise Van Cauwenberge, MD

    Ophtalmology department - CHU liège

    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

January 30, 2018

First Posted

February 6, 2018

Study Start

May 2, 2018

Primary Completion

July 27, 2021

Study Completion

July 27, 2021

Last Updated

February 15, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)