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Active, not recruiting Observational

An Ophthalmic Safety Study in Patients With Breast Cancer

NCT06767462 · tracked via the Priya Life Science Poland tracker
Phase
Observational
Started
2025-03-05
Last updated
2026-06-16

Condition(s) studied

Ophthalmic Safety in Patients With Breast Cancer

Study summary

To assess ophthalmic health in parallel cohorts of patients with breast cancer

Eligibility

Sex
ALL
Min age
18 Years
Max age
130 Years
Healthy volunteers
No
Inclusion Criteria: 1. Signed informed consent in the qualifying study. 2. Signed informed consent in the ophthalmic study prior to any ophthalmic study specific assessments and procedures. 3. Completed the baseline ophthalmic examination for this study before the first dose in the qualifying study. 4. Meets all the eligibility criteria in the qualifying study Exclusion Criteria: 1. Patients not randomized and not receiving study assigned treatment in a qualifying study. 2. Patients with contraindications to any ophthalmic procedure required by the study or sensitivity/allergy to pupil dilating agents. 3. Judgement by the investigator that the patient should not participate in the ophthalmic study if the patient is unlikely to comply with study procedures, restrictions, and requirements

Primary outcome measure(s)

  • Visual Acuity Testing (Snellen units) — Ophthalmic review by central reader until 28 days after End of Study visit.
    To detect potential impairment in central vision in patients with breast cancer.
  • Slit Lamp examination (normal/abnormal) — Ophthalmic review by local ophthalmologist until 28 days after End of Study visit.
    To detect any corneal changes or lens changes (eg, cataracts) that could impact high and low contrast acuity/visual field in patients with breast cancer.
  • Optical Coherence Tonometry (μm) — Ophthalmic review by central reader until 28 days after End of Study visit.
    To assess any structural change/damage to the eye or any long-term visual effects in patients with breast cancer.
  • Fundus Examination (normal/abnormal) — Ophthalmic review by central reader until 28 days after End of Study visit.
    To assess any structural change/damage to the eye or any long-term visual effects in patients with breast cancer.

Trial sites (50)

FacilityCityRegionStatus
Research Site La Jolla California
Research Site Palo Alto California
Research Site Iowa City Iowa
Research Site Winston-Salem North Carolina
Research Site Clairton Pennsylvania
Research Site Pittsburgh Pennsylvania
Research Site Sioux Falls South Dakota
Research Site Bartlett Tennessee
Research Site Houston Texas
Research Site CABA Argentina
Research Site Córdoba Argentina
Research Site Leuven Belgium
Research Site Liège Belgium
Research Site Alfenas Brazil
Research Site Belo Horizonte Brazil
Research Site Curitiba Brazil
Research Site Lajeado Brazil
Research Site Porto Alegre Brazil
Research Site Pouso Alegre Brazil
Research Site São Paulo Brazil
Research Site Sorocaba Brazil
Research Site Três Lagoas Brazil
Research Site Vitória Brazil
Research Site Montreal Quebec
Research Site Montreal Quebec
Research Site Santiago Chile
Research Site Santiago Chile
Research Site Ashdod Israel
Research Site Nahariya Israel
Research Site Lodz Poland
Research Site Amadora Portugal
Research Site Braga Portugal
Research Site Seoul South Korea
Research Site Badalona Spain
Research Site Barcelona Spain
Research Site Barcelona Spain
Research Site Barcelona Spain
Research Site Girona Spain
Research Site L'Hospitalet de Llobregat Spain
Research Site Leganés Spain

+ 10 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06767462 on ClinicalTrials.gov ↗ ← All trials in Poland