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 @ 5:29 PM
Ignite Modification Date:
2025-12-24 @ 5:29 PM
NCT ID:
NCT02866968
Eligibility Criteria:
Inclusion Criteria:
* A pterygium will be defined as a wing-shaped growth of fibrotic connective tissue onto the cornea originating from the nasal conjunctiva.
* Only patients older than 21 years will be included.
* No gender criteria are applied.
* Only individuals with the mental capacity to provide informed consent will be included.
More specifically, all the following inclusion criteria must be met:
* Patients have primary pterygium encroaching onto the cornea by a minimum of 1 mm.
* Patients are willing and able to sign a written Informed Consent Form prior to any study-specific procedures.
* Patients are willing and able to return for scheduled follow-up examinations for 12 months after the surgery.
Exclusion Criteria:
* Patients with prior history of pterygium surgery.
* Patients with a prior history of glaucoma filtration surgery.
* Patients with optic atrophy.
* Patients with ocular pathology or disease that might confound the outcome or increase the risk of adverse events.
* Patients with a prior history of vitrectomy.
* Patients with central corneal scarring.
* Patients with residual, recurrent, active or uncontrolled eyelid disease.
* Patients with any conjunctival scarring other than pterygium, that could affect surgery outcome.
* Patients with anterior segment pathology.
* Patients with any corneal abnormality.
* Patients with any progressive retinal disease or subjects with a history or evidence of retinal vascular occlusion and/or hypercoagulability, because of the risks associated with high pressures during suction application.
* Patients with amblyopia or strabismus or those who are at risk for developing strabismus postoperatively as determined by corneal light reflex and cover-uncover testing.
* Patients who are pregnant, lactating, of child-bearing potential and not practising a medically approved method of birth control, or planning to become pregnant during the course of the trial, and patients with other conditions associated with fluctuation of hormones that could lead to refractive changes.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT02866968
Study Brief:
Protocol Section:
NCT02866968