NCT07176338

Brief Summary

Determination of concentrations of systemically applied metformin in human lens capsule and its ability to lower the proliferation rate of human lens epithelial cells in vitro.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 12, 2022

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 16, 2025

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

September 16, 2025

Status Verified

September 1, 2025

Enrollment Period

3 years

First QC Date

September 8, 2025

Last Update Submit

September 8, 2025

Conditions

CataractDiabetes Mellitus Type 2

Outcome Measures

Primary Outcomes (1)

  • Metformin concentration in the human lens capsule

    12 months

Secondary Outcomes (2)

  • Metformin concentration in human blood

    12 months

  • Influence of Metformin on in vitro proliferation of LECs

    12 months

Study Arms (1)

Metformin Concentration in Blood Serum and Lens capsule

EXPERIMENTAL
Diagnostic Test: Blood and lens capsule samples for PK testing

Interventions

Blood and lens capsule samples for PK testingDIAGNOSTIC_TEST

Blood samples and lens capsule tissue will be collected from patients for PK testing

Metformin Concentration in Blood Serum and Lens capsule

Eligibility Criteria

Age21 Years - 105 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age-related cataract
  • Diabetes mellitus type II
  • Metformin treatment
  • Age 21 or older
  • Written informed consent prior to surgery

You may not qualify if:

  • Diabetes mellitus type I
  • Previous ocular surgery or trauma regarding cataract surgery
  • Previous vitrectomy
  • Pregnancy (pregnancy test will be taken in women of reproductive age)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vienna Institute for Research in Ocular Surgery (VIROS)

Vienna, 1140, Austria

Location

MeSH Terms

Conditions

CataractDiabetes Mellitus, Type 2

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Oliver Findl, Prim. Prof. Dr.

    Vienna Institute for Research in Ocular Surgery (VIROS)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 8, 2025

First Posted

September 16, 2025

Study Start

October 12, 2022

Primary Completion

October 1, 2025

Study Completion

October 1, 2025

Last Updated

September 16, 2025

Record last verified: 2025-09

Locations

AU(1)