Quality Of Life After Eye Surgical Removal

Evisceration; Traumatic, Eye Clinical Trial

— QOLAE  

Official title:

A Prospective Study About Global, Psychological and Visual Quality of Life After an Eye Surgical Removal (Enucleation or Evisceration)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05397743
• Other study ID #: 2022/673
• Status: Recruiting
• Phase: N/A
• Start date: May 23, 2022
• Est. completion date: August 23, 2023

Study information

• Verified date: July 2022
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: SOLECKI Lauriana, MD
• Phone: 0033381668578
• Email: lsolecki[@]chu-besancon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: August 23, 2023
• Est. primary completion date: August 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Patient who underwent bilateral eye removal surgery

Related Conditions & MeSH terms

• Evisceration; Traumatic, Eye

Intervention

Other:
• Quality of Life
Questionnaire Perceived stress scale (PSS) + Questionnaire Short form 36 (SF-36) + Questionnaire Visual functioning questionnaire 25 (VFQ-25)

Locations

Country	Name	City	State
France	CHU de Besançon	Besançon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

References & Publications (3)

Ahn JM, Lee SY, Yoon JS. Health-related quality of life and emotional status of anophthalmic patients in Korea. Am J Ophthalmol. 2010 Jun;149(6):1005-1011.e1. doi: 10.1016/j.ajo.2009.12.036. Epub 2010 Mar 15. — View Citation

Damato B. Improving the quality of life of patients undergoing enucleation. Eye (Lond). 2021 Oct 13. doi: 10.1038/s41433-021-01783-9. [Epub ahead of print] — View Citation

Rasmussen ML, Ekholm O, Prause JU, Toft PB. Quality of life of eye amputated patients. Acta Ophthalmol. 2012 Aug;90(5):435-40. doi: 10.1111/j.1755-3768.2010.02092.x. Epub 2011 Feb 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score VFQ 25 score up to 3 months after surgery	100 = Best score, 0 = Worst possible score	Month 3
Secondary	PSS score up to 3 months after surgery	score from 0 to 13 = low stress; score from 14 to 26 = moderate stress; score from 27 to 40 = high perceived stress.	Month 3
Secondary	SF-36 score up to 3 months after surgery	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	Month 3