Quality Of Life After Eye Surgical Removal

Not Applicable

• Conditions: Evisceration; Traumatic, Eye
• Interventions: Other: Quality of Life

• Registration Number: NCT05397743
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

Brief Summary

Studies have shown that health-related quality of life (HRQOL) was worse among patients who underwent surgical eye removal compared to the general population in Denmark.

A third of eye amputated patients suffered from anxiety and depression. Most of the available evidence on the subject is based on retrospective studies that interviewed patients several years after surgery, which can potentially introduce biases.

Moreover, in the literature, there are no data concerning postoperative psychological and visual impact.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-18
• Study Start: 2022-05-23
• Study First Submitted QC: 2022-05-25
• Study First Posted: 2022-05-31
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-25
• Last Update Posted: 2022-07-26
• Primary Completion: 2023-08-23
• Study Completion: 2023-08-23

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patient who underwent an eye removal surgery: evisceration, enucleation or exenteration

Exclusion Criteria

• Patient who underwent bilateral eye removal surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Questionnaires	Quality of Life	Questionnaires for global, psychological and visual Quality of Life (QoL)

Primary Outcome Measures

Name	Time	Method
Score VFQ 25 score up to 3 months after surgery	Month 3	100 = Best score, 0 = Worst possible score

Secondary Outcome Measures

Name	Time	Method
PSS score up to 3 months after surgery	Month 3	* score from 0 to 13 = low stress; * score from 14 to 26 = moderate stress; * score from 27 to 40 = high perceived stress.
SF-36 score up to 3 months after surgery	Month 3	The SF-36, as described in the name, is a 36-item patient-reported questionnaire that covers eight health domains: physical functioning (10 items), bodily pain (2 items), role limitations due to physical health problems (4 items), role limitations due to personal or emotional problems (4 items), emotional well-being (5 items), social functioning (2 items), energy/fatigue (4 items), and general health perceptions (5 items). Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state

Trial Locations

Locations (1)

CHU de Besançon; 🇫🇷 Besançon, France