Subjective Perception of Ocular Prosthesis Wear

Completed

• Conditions: Anophthalmos, Unilateral; Prosthesis User

• Registration Number: NCT04321382
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2020-02-01
• Study Completion: 2020-02-01
• Status Verified: 2020-03
• Study First Submitted: 2020-03-23
• Study First Submitted QC: 2020-03-23
• Last Update Submitted: 2020-03-23
• Study First Posted: 2020-03-25
• Last Update Posted: 2020-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• acquired anophthalmia
• Informed consent
• ocular prosthesis wear for minimum of 2 years

Exclusion Criteria

• congenital anophthalmia
• microphthalmia

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of care	1 hour	disease specific score

Trial Locations

Locations (1)

University Hospitals Leuven; 🇧🇪 Leuven, Belgium