Quality Of Life After Eye Surgical Removal

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05397743

Acronym

QOLAE

Enrollment

Registered

2022-05-31

Start date

2022-05-23

Completion date

2023-08-23

Last updated

2022-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Evisceration; Traumatic, Eye

Keywords

Enucleation

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.

Interventions

OTHERQuality of Life

Questionnaire Perceived stress scale (PSS) + Questionnaire Short form 36 (SF-36) + Questionnaire Visual functioning questionnaire 25 (VFQ-25)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Patient who underwent bilateral eye removal surgery

Design outcomes

Primary

Measure	Time frame	Description
Score VFQ 25 score up to 3 months after surgery	Month 3	100 = Best score, 0 = Worst possible score

Secondary

Measure	Time frame	Description
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

Countries

France

Contacts

Primary ContactSOLECKI Lauriana, MD

lsolecki@chu-besancon.fr0033381668578

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026