Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:30 PM
Ignite Modification Date:
2025-12-24 @ 7:30 PM
NCT ID:
NCT01162603
Eligibility Criteria:
Inclusion Criteria:
* Male and female patients \> 45 years
* Damage of the optic nerve and alterations of the visual field in case of POAG, no defects at the optic nerve and at the visual field in case of OHT
* Untreated IOP \> 24 mm Hg but \< 32 mm Hg in at least one eye at baseline (10AM) and central corneal thickness between 500 and 600 μm
* Negative pregnancy test (fertile women). Fertile women attending the study must express clear will to avoid pregnancy during all the study period and in the next three months
* Informed consent before starting the study
Exclusion Criteria:
* Secondary glaucoma (Sturge-Weber syndrome, Neurofibromatosis I, neovascular glaucoma, steroid glaucoma, etc)
* Anterior segment anomalies (cataract, irido-corneal disgenesy, congenital ectropion uvae, etc)
* Past ocular surgery, except cataract surgery in the previous 6 months
* Corneal abnormalities that can influence IOP measurements (corneal oedema)
* Positive pregnancy test or breast-feeding woman. No will to avoid pregnancy during all the study period and in the next three months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Study:
NCT01162603
Study Brief:
Protocol Section:
NCT01162603