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 @ 6:44 PM
Ignite Modification Date:
2025-12-24 @ 6:44 PM
NCT ID:
NCT05279157
Eligibility Criteria:
Inclusion Criteria:
* Patients affected by corneal stromal dystrophies of any type, but particularly keratoconus, showing clear evidence in the ophthalmic examination of the presence and clear expression of the disease and loss of vision as a result of it
* Patients with best-corrected visual acuity less than 0.6
* Absence of chronic or recurrent inflammation in the anterior segment and on the ocular surface.
* Patient suitable to undergo corneal graft surgery under local anesthesia, from a medical point of view.
* Pre-surgical analysis of serum biochemistry and normal hematology.
* Serology for Human Immunodeficiency Virus (HIV), Hepatitis B (HBV), and Hepatitis C (HCV) negative.
* No history of malignancy.
* Normal chest x-ray (Rx).
* Normal urinalysis.
* Normal thyroid exam
Exclusion Criteria:
* Dense and extensive corneal stromal scars with severe involvement of the visual axis and located in the pupillary area, causing a decrease in the best corrected vision to levels of 0.1 or less.
* Distance corrected vision with glasses of 0.7 or greater.
* Extreme corneal thinning with risk of perforation.
* Infection.
* Previous corneal surgeries.
* Moderate or severe dry eye.
* Moderate or severe chronic inflammatory pathology of the ocular surface.
* Previous eye surgery other than cataract.
* Presence of cataract or other severe opacity of the transparent media of the eye that could prevent adequate examination of the fundus.
* Other ophthalmic comorbidity such as glaucoma or uveitis or any that requires the chronic use of topical ocular medication.
* Known and severe coagulation abnormalities.
* Any medical condition that may interfere with causing serious adverse effects during the study.
* Presence of active or inactive corneal neovascularization (CNV) in the eye to be treated
* Any immunodeficiency or systemic autoimmune disease
* Any current or intermittent immunosuppressive therapy or low-dose corticosteroids.
* Renal insufficiency, defined by creatine value\> 1.3 mg / dL.
* Serological evidence of hepatitis B, hepatitis C, or HIV infection.
* Pregnant or lactating woman.
* Corrected visual acuity in the eye contralateral to the experimental eye less than 20/40 (0.5)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT05279157
Study Brief:
Protocol Section:
NCT05279157