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:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-25 @ 3:54 AM
NCT ID:
NCT01312402
Eligibility Criteria:
Inclusion Criteria:
* Age; greater than 12 years old and able to cooperate for full study protocol
* Subject able to understand and sign informed consent
* Subject able to participate in complete ophthalmic and ocular motility evaluation
* Subjects with Infantile Nystagmus Syndrome diagnosed by clinical evaluation and eye movement recordings
* Best-binocular visual acuity in null position 20/50 to 20/200 inclusive using ATS or ETDRS vision testing
* Subject/family able and willing to make the required study visits
* No previous ophthalmic treatment for nystagmus other than for refractive error
Exclusion Criteria:
* Any current use of systemic or topical medications (traditional or non-traditional)
* History of ocular surgery, trauma or chronic ocular disease other than amblyopia
* Systemic diseases requiring medication or other treatments that are known to affect the ocular motor system (e.g., depression, seizure disorders, psychosis)
* Behavioral or neurological disorders which interfere with the study
* Physical or mental impairment precluding study compliance
* Participation in any study involving an IND investigational drug within the past year
* Individual (female) is pregnant, nursing or planning a pregnancy (The safety of Azopt for use during pregnancy has NOT been determined.)
* Periodicity or aperiodicity of INS present on eye movement recordings
* Allergy to sulfa or other components of Azopt solution
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT01312402
Study Brief:
Protocol Section:
NCT01312402