NCT03796624

Brief Summary

Prospective, non-randomised, open, controlled, single-center post-market clinical follow study about Micropure 1.2.3. and PODEYE intraocular lenses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2019

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 4, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 8, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

February 12, 2019

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 17, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 17, 2021

Completed
Last Updated

July 9, 2021

Status Verified

July 1, 2021

Enrollment Period

2.3 years

First QC Date

January 4, 2019

Last Update Submit

July 8, 2021

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 eyes implanted with the comparator PODEYE at the 6 months follow up visit.

    6 months postoperative

Secondary Outcomes (17)

  • Manifested refraction

    preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative

  • Monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions

    preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative

  • Monocular Uncorrected Distance Visual Acuity (UDVA) under mesopic light conditions

    preoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative

  • Monocular Corrected Distance Visual Acuity (CDVA) under photopic light conditions

    preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative

  • Monocular Corrected Distance Visual Acuity (CDVA) under mesopic light conditions

    preoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative

  • +12 more secondary outcomes

Other Outcomes (4)

  • Intraocular pressure (IOP) measurement

    preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative

  • Questionnaire on IOL implantation

    peroperative

  • Keratometry

    preoperative

  • +1 more other outcomes

Study Arms (2)

Investigational Device Micropure 1.2.3.

EXPERIMENTAL

Implantation of monofocal intraocular lens (IOL) "Micropure 1.2.3." in one of the eyes of the study subject

Device: Micropure 1.2.3.

Comparator PODEYE

ACTIVE COMPARATOR

Implantation of monofocal intraocular lens (IOL) "PODEYE" in the contralateral eye of the study subject

Device: PODEYE

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 patient will be implanted

Investigational Device Micropure 1.2.3.
PODEYEDEVICE

Implantation of intraocular lens (IOL). Name: "PODEYE" It is a monofocal intraocular lens consisting of hydrophobic acrylic material. The IOL will be implanted in the contralateral eye of the same patient already implanted with Micropure 1.2.3.

Comparator PODEYE

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
  • Clear intraocular media other than cataract;
  • Signed informed consent

You may not qualify if:

  • Age of patient \< 45 years;
  • Irregular astigmatism;
  • 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);
  • Previous intraocular or corneal surgery;
  • Traumatic cataract;
  • Any ocular comorbidity;
  • Instability of keratometry or biometry measurements.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GEMINI Eye Clinic

Zlín, 76001, Czechia

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Pavel Stodůlka, MD, PhD

    Gemini Eye Clinic

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 4, 2019

First Posted

January 8, 2019

Study Start

February 12, 2019

Primary Completion

June 17, 2021

Study Completion

June 17, 2021

Last Updated

July 9, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

CZ(1)