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 @ 6:38 PM
Ignite Modification Date:
2025-12-24 @ 6:38 PM
NCT ID:
NCT01123057
Eligibility Criteria:
Inclusion Criteria:
* Patients must have clinical evidence of keratoconus or LASIK keratectasia (moderate to severe)
* Visual acuity with contact lenses must be better than or equal to 6/12 (20/40).
* Patients must be intolerant of contact lenses, i.e., they must be unable to wear contact lenses for a whole day.
* Patients should have a minimum of corneal thickness of 400um (with cornea at swollen state denuded of epithelium during surgery).
* In terms of general health, patients must not have any illnesses posing an immediate threat to life.
* Patients must over 18 years of age.
* Patients' contact lens wear must be stopped 3 days prior to preop assessment
* Patients can wear their lenses up to the day before the surgery
* Any vitamin C intake must be stopped 1 week prior to surgery
* Both eyes may be recruited if eligible.
* Patients with other non-inflammatory corneal thinning disorders such as pellucid marginal degeneration, keratoglobus and posterior keratoconus may be recruited
Exclusion Criteria:
* corneal thickness \<400 µm in swollen state
* epithelial healing disorders (e.g. map-dot-fingerprint dystrophy, rheumatic disorders)
* refractive keratotomies
* corneal melting conditions
* herpes keratitis (UV can activate this herpes virus)
* associated systemic disorder such as Down's syndrome
* Pregnancy
* Breast-feeding.
* Patients with history of herpetic keratitis.
* Patients with autoimmune diseases
* Patients with IOP \>21mmHg
* Patients with cataracts
* Patients taking part in other biomedical research in the 30 days prior to the start of this study.
* Patients with alcohol abuse, psychological weakness, or an uncooperative disposition.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01123057
Study Brief:
Protocol Section:
NCT01123057