An observational study in Retinoschisis and X-Linked, sponsored by National Eye Institute (NEI). Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-01.
Sponsored by National Eye Institute (NEI) · Observational
Among 10 studies in Retinoschisis with a site in United States — 3 open to participants now, 3 under way, 1 of them phase 3. Retinoschisis · United States.
Among the 10 studies in Retinoschisis with a site in United States, this one is the only one that started in 2017, is one of 6 observational ones, and was the 8th registered.
19 studies on the registry are indexed under Retinoschisis; 5 are open to participants now.
Browse Retinoschisis studies →3 of the 10 studies in Retinoschisis with a site in United States are open now, in 3 countries. Each count lists the studies.
Of the 5 Retinoschisis studies recruiting now, 4 (80%) set no upper age limit and 1 (20%) stop at 75 or younger; 4 take children under 18; 1 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →10 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 1 started in 2017.
Median enrollment 43 across the 4 interventional studies, 46 across the 6 observational. Of the 7 that completed or were terminated, 3 (43%) have results posted.
5 of 10 have an industry lead sponsor. The 7 most frequent:
National Eye Institute (NEI) is the lead sponsor of 272 studies on the registry; 17 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 8 (100%) have results posted.
National Eye Institute (NEI) has 3 studies filed under Retinoschisis — fewer than ten, so there is no comparison to draw.
1 of the studies in Retinoschisis with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07502664Ray Therapeutics, Inc.Development and Evaluation of Functional Visual Field and Navigation Endpoints in Moderate to Profound Inherited Retinal Disease (DEFINE-IRD) | 2027-02 |
Among the 10 studies in Retinoschisis with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
Background:
X-linked retinoschisis (XLRS) is a genetic condition. It usually presents in boys in childhood with vision loss. Genetic conditions affect the people who have it and also their family members. Researchers want to learn if mothers and fathers react differently when a son gets XLRS. They also want to learn how personality impacts the way people react. This will help researchers find better ways to support families living with XLRS.
Objective:
To learn more about the experiences of mothers of sons with XLRS compared to fathers of sons with XLRS. Also to study personality differences between mothers and fathers.
Eligibility:
Parents of a biological son of any age with XLRS who is enrolled in protocol 03-EI-0033
Design:
Participants will be asked questions in person or by phone. This will last 30 90 minutes. They will be asked about their experience with XLRS and how it has impacted their family. The interview will be recorded.
Participants will complete a survey about personality traits. It will be anonymous. It can be completed by mail, email, or fax. It will take about 15 minutes.
Participants data may be shared with others, including those not at NIH, if they agree. Their data may be stored.
Sponsoring Institution: National Eye Institute
OBJECTIVE: The objective of this study is to explore the experiences of mothers of sons with X-linked retinoschisis (XLRS) compared to fathers of sons with XLRS and to draft a personality profile of both mothers and fathers based on the findings.
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STUDY POPULATION: Up to 50 mothers of sons of all ages diagnosed with XLRS are eligible to participate in this study. Up to 50 fathers of sons of all ages with XLRS are also eligible to participate and will serve as a comparison group.
DESIGN: This is a pilot mixed-methods study that involves a cross sectional qualitative interview and a self-administered questionnaire. Participants will be recruited through a "parent" study "Clinical and Molecular Studies of X-linked Retinoschisis" (03-EI-0033). Interviews will be conducted either in person at the National Institutes of Health Clinical Center (NIH CC) or by telephone. The interview will explore the experiences and impact of having a son with XLRS. Interviews will be recorded, transcribed verbatim, coded by two independent coders, and analyzed thematically. Participants will also be asked to complete a questionnaire to assess personality traits, anxiety, and optimism, using scales shown to be valid and reliable in the general population and in clinical samples. Results from these scales will provide information about variables that cannot be reliably assessed from an interview. This study is not designed to assess causality; rather, it will be used to generate hypotheses and inform future social and behavioral and/or basic science research studies of parents of sons with XLRS.
OUTCOME MEASURES: The primary outcomes of this study include a description of the experiences of mothers of sons with XLRS compared to fathers of sons with XLRS and a preliminary personality profile of mothers and fathers.
Up to 50 mothers of sons of all ages diagnosed with XLRS are eligible to participate in this study. Up to 50 fathers of sons of all ages with XLRS are also eligible to participate and will serve as a comparison group.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants may be eligible to take part in this study if they: Have a biological son of any age with XLRS who is enrolled in XLRS Clinical and Molecular Studies protocol (03-EI-0033).
EXCLUSION CRITERIA:
-Participants may not be able to take part in this study if they:
Up to 50 mothers of sons of all ages diagnosed with XLRS are eligible to participate in this study. Up to 50 fathers of sons of all ages with XLRS are also eligible to participate and will serve as a comparison group.
Description of the experiences of mothers of sons with XLRS compared to fathers of sons with XLRS
Time frame: Study Completion
Ran from Dec 2017 to primary completion in Oct 2019, 22 months.
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This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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National Eye Institute (NEI) →