NCT05397743

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

May 23, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 31, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2023

Completed
Last Updated

July 26, 2022

Status Verified

July 1, 2022

Enrollment Period

1.3 years

First QC Date

May 18, 2022

Last Update Submit

July 25, 2022

Conditions

Evisceration; Traumatic, Eye

Keywords

Enucleation

Outcome Measures

Primary Outcomes (1)

  • Score VFQ 25 score up to 3 months after surgery

    100 = Best score, 0 = Worst possible score

    Month 3

Secondary Outcomes (2)

  • PSS score up to 3 months after surgery

    Month 3

  • SF-36 score up to 3 months after surgery

    Month 3

Study Arms (1)

Questionnaires

EXPERIMENTAL

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

Other: Quality of Life

Interventions

Quality of LifeOTHER

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

Questionnaires

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patient who underwent bilateral eye removal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Besançon

Besançon, 25000, France

RECRUITING

Related Publications (3)

  • 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.

    PMID: 21310012BACKGROUND

  • 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.

    PMID: 20231012BACKGROUND

  • 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.

    PMID: 34645962BACKGROUND

MeSH Terms

Interventions

Quality of Life

Intervention Hierarchy (Ancestors)

Health StatusDemographyEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Lauriana SOLECKI, MD

    CHU de Besançon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

SOLECKI Lauriana, MD

CONTACT

0033381668578lsolecki@chu-besancon.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2022

First Posted

May 31, 2022

Study Start

May 23, 2022

Primary Completion

August 23, 2023

Study Completion

August 23, 2023

Last Updated

July 26, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)