Subjective Perception of Ocular Prosthesis Wear

Prosthesis User Clinical Trial

Official title:

Subjective Perception of Ocular Prosthesis Wear

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04321382
• Other study ID #: s61570
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: February 1, 2020

Study information

• Verified date: March 2020
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The loss of an eye, whether congenital or acquired, is a severe psychological trauma with negative impact on the quality of life of the patient. While rehabilitation with a customized ocular prosthesis anatomically restores the facial appearance, the final outcome is largely determined by the subjective satisfaction of the patient. By investigating the level of subjective perception, the quality of care can be improved.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 1, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• acquired anophthalmia

• Informed consent

• ocular prosthesis wear for minimum of 2 years

Exclusion Criteria:

• congenital anophthalmia

• microphthalmia

Related Conditions & MeSH terms

• Anophthalmos
• Anophthalmos, Unilateral
• Prosthesis User

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of care	disease specific score	1 hour