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:
2025-12-26 @ 1:17 PM
Ignite Modification Date:
2025-12-26 @ 1:17 PM
NCT ID:
NCT00808106
Eligibility Criteria:
* INCLUSION CRITERIA:
Patients will be screened by requesting copies of the following materials at the time they contact the program:
1. An indication of ethnic background by the potential participant, which may be unknown .
2. Photographs of the potential participant that give an indication of skin complexion/pigmentation and undyed hair color (if available).
3. Ophthalmology or other visual specialist records documenting visual exam characteristics, potentially including iris transillumination, visual evoked potential and or characteristic eye findings (if available).
4. Genetic testing results (if available).
EXCLUSION CRITERIA:
Exclusion from the study will be made based on one or more of the following criteria:
1. Significant evidence that the potential participant has either OCA1A or OCA2 with a typical presentation, AND has an ethnic background that is wellrepresented in the current study (proportion in study exceeding the proportion in the United States population).
The rationale for this exclusion is that: 1) from a biologicaland clinicalresearch perspective, we have an adequate number of OCA1A/
OCA2 cases in the current study population; and 2) that, despite this, persons with ethnicities that are underrepresented in the study may inform our understanding of populationlevel molecular patterns in OCA1A/ OCA2 and cultural implications of albinism.
2. Persons who are under 1 year of age. This exclusion occurs because there is no urgency for a very early evaluation. Also, the Clinical Center staff and resources are more suited for the care of older children.
3. Persons who are too sick to travel safely to the NIH Clinical Center.
4. A judgment by the principal investigator that clinical resources are not available to enroll additional patients at any given time.
5. Persons who are currently incarcerated.
6. Adults who are incompetent to consent to the protocol.
7. Persons who have been diagnosed with a known nonoculocutaneous disorder of hypopigmentation such as HemanskyPudlak Syndrome, ChediakHigashi Syndrome, or Griscelli Syndrome.
8. Persons who have been diagnosed with a known disorder of focal hypopigmentation such as Waardenburg syndrome.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
80 Years
Study:
NCT00808106
Study Brief:
Protocol Section:
NCT00808106