Quality Of Life After Eye Surgical Removal

NCT ID: NCT05397743

Last Updated: 2022-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-23

Study Completion Date

2023-08-23

Brief Summary

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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.

Detailed Description

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Conditions

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Evisceration; Traumatic, Eye

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Questionnaires

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

Group Type EXPERIMENTAL

Quality of Life

Intervention Type OTHER

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

Interventions

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Quality of Life

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Patient who underwent bilateral eye removal surgery
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lauriana SOLECKI, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de Besançon

Locations

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CHU de Besançon

Besançon, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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SOLECKI Lauriana, MD

Role: CONTACT

0033381668578

Facility Contacts

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Lauriana SOLECKI, MD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 21310012 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20231012 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34645962 (View on PubMed)

Other Identifiers

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2022/673

Identifier Type: -

Identifier Source: org_study_id

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