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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06345976
Other study ID # RLX_2023_10
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 2024
Est. completion date May 2025

Study information

Verified date March 2024
Source Fondation Ophtalmologique Adolphe de Rothschild
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Albinism is a genetic and hereditary anomaly that affects pigmentation. This pathology is characterized by a deficit in melanin production. In humans, the clinical diagnosis of albinism is based on a number of factors, including : - In the integumentary region: fair skin tone, with white hair, eyelashes and eyebrows. - Ophthalmological: reduced visual acuity, photophobia, nystagmus, transilluminated blue irises, hypopigmentation of the retina at the back of the eye with fovea plana. As treatment options begin to emerge for certain albinism-induced anomalies (including, for example, the depigmentation that causes photophobia), it is desirable to understand what these patients' complaints are, and to gather their views on the emergence of treatments targeting just one of their complaints, namely glare.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date May 2025
Est. primary completion date May 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - All patients with albinism - Patients > 18 years of age - Non-opposition to study participation Exclusion Criteria: No diagnosis according to Kruijt et al. criteria Impossibility (visual, technological) of completing questionnaire

Study Design


Related Conditions & MeSH terms


Intervention

Other:
questionnaire
On-line self-questionnaire, in the form of an 18-question form, the link to which is sent by e-mail to patients with albinism who have agreed to take part in the study.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Outcome

Type Measure Description Time frame Safety issue
Primary To determine whether patients with albinism would be interested in a treatment that could improve their glare without improving their visual acuity. To determine whether patients with albinism would be interested in a treatment that could improve their glare without improving their visual acuity.
Percentage of positive responses to question "Would you be interested in the possibility of a treatment for glare if it did not improve the quality of vision or visual stability?"
Day0
See also
  Status Clinical Trial Phase
Recruiting NCT04495218 - NGS Panel of Incomplete Forms of Ocular Albinism
Completed NCT00001153 - Visual Function and Ocular Pigmentation in Albinism N/A
Completed NCT03959605 - Genetic Determinant of Foveolar Hypoplasia in Parents of Albinos Children