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NCT04770519 Clinical Trial

Genetic Studies of Strabismus, Nystagmus, and Associated Disorders

Strabismus Clinical Trial

Official title:
Genetic Studies of Strabismus, Nystagmus, and Associated Disorders

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04770519
Other study ID # IRB-P00036313
Secondary ID R01EY032539
Status Recruiting
Phase
First received
Last updated
Start date September 3, 2021
Est. completion date December 2026

Study information
Verified date May 2024
Source Boston Children's Hospital
Contact Tapiwa Muvavarirwa, BA
Phone 857-292-3768
Email research.whitman@childrens.harvard.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Strabismus (misalignment of the eyes) often runs in families. In this study, the investigators are looking for genetic variants associated with strabismus and nystagmus. Three types of subects will be enrolled: (1) Families with at least 3 members with strabismus, (2) individuals with infantile esotropia and their parents and siblings, and (3) individuals with infantile nystagmus and their parents. Whole exome and/or whole genome sequencing will be used to identify genetic variants shared by family members with strabismus and to identify genetic causes of nystagmus.

Recruitment information / eligibility
Status Recruiting
Enrollment 400
Est. completion date December 2026
Est. primary completion date December 2026
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Member of a family with at least 3 biological relatives with strabismus. (Both affected and non-affected family members will be enrolled). OR - Member of a family with at least 1 individual with infantile esotropia. (Both affected and non-affected family members will be enrolled). OR - Member of a family with at least 1 individual with infantile nystagmus. (Both affected and non-affected family members will be enrolled). Exclusion Criteria: - paralytic strabismus in affected family members

Study Design

Related Conditions & MeSH terms

Intervention

Genetic:
• whole genome sequencing or whole exome sequencing
Whole genome sequencing or whole exome sequencing will be performed for all enrolled participants.

Locations
Country Name City State
United States Boston Children's Hospital Boston Massachusetts

Sponsors (2)
Lead Sponsor Collaborator
Boston Children's Hospital National Eye Institute (NEI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Genetic variants genetic variants shared by family members with strabismus 2 years
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