Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03354403
Other study ID # 180016
Secondary ID 18-EI-0016
Status Completed
Phase
First received
Last updated
Start date December 1, 2017
Est. completion date October 30, 2019

Study information

Verified date October 2019
Source National Institutes of Health Clinical Center (CC)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


Description:

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.



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.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date October 30, 2019
Est. primary completion date October 30, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility - INCLUSION CRITERIA:

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:

- Are unable to understand and comply with the procedures of this study.

- Cannot communicate in English orally and in writing.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States National Institutes of Health Clinical Center Bethesda Maryland

Sponsors (1)

Lead Sponsor Collaborator
National Eye Institute (NEI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Description of the experiences of mothers of sons with XLRS compared to fathers of sons with XLRS Study Completion
See also
  Status Clinical Trial Phase
Completed NCT02682797 - Optical Coherence Tomography Evaluation of Retinoschisis and Retinal Detachment N/A
Active, not recruiting NCT00055029 - Clinical and Genetic Studies of X-Linked Juvenile Retinoschisis
Recruiting NCT06289452 - Safety and Efficacy Study of IVB102 Injection in Subjects With X-linked Retinoschisis Early Phase 1
Recruiting NCT02435940 - Inherited Retinal Degenerative Disease Registry
Completed NCT01995045 - Postoperative Pain Control Following Vitreoretinal Surgery Phase 4
Recruiting NCT06114537 - The AXIS Study: the Efficacy of Acetazolamide for the Treatment of Cystoid Fluid Collections in Retinoschisis Phase 2
Active, not recruiting NCT02317887 - Study of RS1 Ocular Gene Transfer for X-linked Retinoschisis Phase 1/Phase 2
Completed NCT02317354 - People s Expectations When Enrolling in a Phase I/II RS1 Ocular Gene Transfer Clinical Trial
Completed NCT03023800 - Effects of Macular Buckle Versus Vitrectomy on Macular Schisis and Macular Detachment in Highly Myopic Eyes N/A