The Prevalence of CTX Disorder in Juvenile Cataract Cases in Turkey

NCT03584893 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2021-03-29

No results posted yet for this study

Summary

Epidemiologic observational study. Study will include two phases:

1. Retrospective cross-sectional phase: At this stage of the study, retrospective screenings are carried out at study sites and all juvenile cataract cases are planned to be determined.
2. Prospective phase: At this stage of the study, identified juvenile cataract cases as a result of retrospective screenings will be called to be invited to the sites and blood samples will be obtained for the cholestanol tests for the cases that have given Informed Consent.

This observational study is designed in two phases; retrospective and prospective. Retrospective part includes screening the patient database and / or patient files at ophthalmology clinics participating in the study and identifying patients diagnosed with idiopathic juvenile cataracts. The data of patients with idiopathic juvenile cataracts will be reviewed and the data of the patients meeting the inclusion/exclusion criteria will be recorded. Once this phase is completed, the prospective phase of the study will start and the patients meeting the criteria will be invited to the site to participate in the study. Current data will be collected from the patients who agree to participate in the study and the clinical status of the patients will be evaluated according to the Mignarri index. In addition, blood will be obtained from all patients to diagnose CTX disease. Blood samples will be sent to Duzen Laboratories in Ankara and analyzed for cholestanol.

Conditions

  • Cerebrotendinous Xanthomatosis

Interventions

PROCEDURE

Blood sampling for Cholestanol Analysis

Cholestanol analysis will be performed to see the Rate of juvenile cataract patients whose cholestanol test result is above threshold (3.75 mg/mL) and suspected CTX cases

Sponsors & Collaborators

  • Klinar CRO

    collaborator OTHER
  • Düzen Laboratories Group

    collaborator UNKNOWN
  • TRPHARM

    lead INDUSTRY

Eligibility

Min Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2022-12-31
Completion
2023-03-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03584893 on ClinicalTrials.gov