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Status unknownNCT05397743QOLAEUpdated Jul 26, 2022

Quality Of Life After Eye Surgical Removal

An interventional study of Quality of Life in Evisceration; Traumatic, Eye, sponsored by Centre Hospitalier Universitaire de Besancon. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-26.

Sponsored by Centre Hospitalier Universitaire de Besancon · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Jul 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Evisceration; Traumatic, Eye

Keywords

  • Enucleation
03

In context

Lead sponsor

Centre Hospitalier Universitaire de Besancon is the lead sponsor of 449 studies on the registry; 98 are open to participants now.

Browse Centre Hospitalier Universitaire de Besancon studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patient who underwent bilateral eye removal surgery
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Questionnaires

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

    Other: Quality of Life

Interventions

  • OtherQuality of Life

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

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What researchers measure

Primary outcomes

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

    100 = Best score, 0 = Worst possible score

    Time frame: Month 3

Secondary outcomes

  1. 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.

    Time frame: Month 3

  2. 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

    Time frame: Month 3

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • 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. PubMed 21310012 ↗
  • 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. PubMed 20231012 ↗
  • Damato B. Improving the quality of life of patients undergoing enucleation. Eye (Lond). 2022 Aug;36(8):1711. doi: 10.1038/s41433-021-01783-9. Epub 2021 Oct 13. No abstract available. PubMed 34645962 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started May 2022 (actual). Primary completion is estimated for Aug 2023, 15 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
May 18, 2022
First posted
May 31, 2022
StartActual
May 23, 2022
Primary completionEst.
Aug 23, 2023
CompletionEst.
Aug 23, 2023
Last update
Jul 26, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 26, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05397743
Lead sponsor
Centre Hospitalier Universitaire de Besancon
Responsible party
Sponsor
First posted
May 31, 2022
Start date
May 23, 2022
Primary completion
Aug 23, 2023 (estimated)
Completion
Aug 23, 2023 (estimated)
Last update
Jul 26, 2022

Study contacts

SOLECKI Lauriana, MD
Contact
lsolecki@chu-besancon.fr
0033381668578
Lauriana SOLECKI, MD
principal investigator · CHU de Besançon

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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