Eligibility Module

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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 @ 7:46 PM
Ignite Modification Date: 2025-12-24 @ 7:46 PM
NCT ID: NCT03396003
Eligibility Criteria: Inclusion Criteria: * Satisfies one of the subject group categories and the enrollment quota for that category has not been reached: 1. Normal eyes (phakic eyes without cataracts or corneal disease, refraction ≥ -5.5 D or ≤ +5.0 D) 2. Eyes having undergone previous refractive surgery (LASIK or PRK) 3. Eyes with cataracts (LOCS III grading with grades 2-6 in any or all of the posterior subcapsular (P2-P5), nuclear (N2-N5) and cortical (C2-C5), assessed by slit lamp examination; no other known ocular pathology) 4. Eyes with severe myopia (≤ -6 D according to the American Academy of Ophthalmology) 5. Eyes with severe hyperopia (≥ +5.25 D according to the American Academy of Ophthalmology) 6. Eyes with previous cross-linking and eyes with advanced keratoconus * Manifest refraction sSpherical eEquivalent Refraction (MRSER) between -10dpt and +10dpt as measured by cycloplegic autorefraction assessed less than 12 months prior to enrollment * Best corrected visual acuity (BCVA) of LogMAR 0.2 or better Exclusion Criteria: * Strabismus, nystagmus, amblyopia, anisometropia (difference in MRSER\>3D) * Angle closure glaucoma * Seizure disorder, brain damage, Down Syndrome, Trisomy 13 or 18, Cerebral Palsy or other serious ophthalmic or central nervous system disorders * Severe dry eye * Severe corneal scarring * Inability to hold gaze * Inability to see fixation target
Healthy Volunteers: True
Sex: ALL
Minimum Age: 18 Years
Study: NCT03396003
Study Brief:
Protocol Section: NCT03396003