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QOLAE: Quality Of Life After Eye Surgical Removal

Sponsor
Centre Hospitalier Universitaire de Besancon (Other)
Overall Status
Recruiting
CT.gov ID
NCT05397743
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
15
Anticipated Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Quality of Life
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
A Prospective Study About Global, Psychological and Visual Quality of Life After an Eye Surgical Removal (Enucleation or Evisceration)
Actual Study Start Date :
May 23, 2022
Anticipated Primary Completion Date :
Aug 23, 2023
Anticipated Study Completion Date :
Aug 23, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Questionnaires

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

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

Outcome Measures

Primary Outcome Measures

  1. Score VFQ 25 score up to 3 months after surgery [Month 3]

    100 = Best score, 0 = Worst possible score

Secondary Outcome Measures

  1. 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.

  2. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patient who underwent an eye removal surgery: evisceration, enucleation or exenteration
Exclusion Criteria:
  • Patient who underwent bilateral eye removal surgery

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU de Besançon Besançon France 25000

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Besancon

Investigators

  • Principal Investigator: Lauriana SOLECKI, MD, CHU de Besançon

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier:
NCT05397743
Other Study ID Numbers:
  • 2022/673
First Posted:
May 31, 2022
Last Update Posted:
Jul 26, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Hospitalier Universitaire de Besancon
Enucleation

Study Results

No Results Posted as of Jul 26, 2022