Evisceration; Traumatic, EyeQOLAENCT05397743
Quality Of Life After Eye Surgical Removal
A study testing Quality of Life in people with Evisceration; Traumatic, Eye, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Evisceration; Traumatic, Eye
- What is being tested?
- Quality of Life
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 23 May 2022to 23 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient who underwent an eye removal surgery: evisceration, enucleation or exenteration
Who cannot join
- Patient who underwent bilateral eye removal surgery
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Besançon
Besançon, 25000
Lauriana SOLECKI, MD, lsolecki@chu-besancon.fr
About this study
Official title: A Prospective Study About Global, Psychological and Visual Quality of Life After an Eye Surgical Removal (Enucleation or Evisceration)
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.
- Conditions
- Evisceration; Traumatic, Eye
- Being tested
- Quality of Life
- Keywords
- Enucleation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of LifeOther
Questionnaire Perceived stress scale (PSS) + Questionnaire Short form 36 (SF-36) + Questionnaire Visual functioning questionnaire 25 (VFQ-25)
| Study group | Role | What they receive |
|---|---|---|
| Questionnaires | Experimental | Questionnaires for global, psychological and visual Quality of Life (QoL) Receives: Other: Quality of Life |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score VFQ 25 score up to 3 months after surgery
100 = Best score, 0 = Worst possible score
Measured: Month 3
Secondary outcomes (2)
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.
Measured: Month 3
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
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start23 May 2022
- Primary completion23 Aug 2023 (estimated)
- Study completion23 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Evisceration; Traumatic, EyeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lauriana SOLECKI, MD, Principal investigator, CHU de Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05397743
- Sponsor's protocol ID
- 2022/673
- Acronym
- QOLAE
- Status last verified
- Jul 2022
- First submitted
- 18 May 2022
- Last updated
- 26 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 21310012Ahn 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 20231012Damato 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
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study About Global, Psychological and Visual Quality of Life After an Eye Surgical Removal (Enucleation or Evisceration)
- ClinicalTrials.gov ID
- NCT05397743
- Acronym / sponsor ID
- QOLAE / 2022/673
- Conditions
- Evisceration; Traumatic, Eye
- Keywords
- Enucleation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 23 May 2022 (actual)
- Primary completion
- 23 Aug 2023 (estimated)
- Study completion
- 23 Aug 2023 (estimated)
- First posted
- 31 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Questionnaires | Experimental | Other: Quality of LifeQuestionnaires for global, psychological and visual Quality of Life (QoL) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient who underwent an eye removal surgery: evisceration, enucleation or exenteration
Key exclusion criteria (1 listed)
- Patient who underwent bilateral eye removal surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality of LifeQuestionnaire Perceived stress scale (PSS) + Questionnaire Short form 36 (SF-36) + Questionnaire Visual functioning questionnaire 25 (VFQ-25) | Other | Questionnaires |
Primary outcome
Score VFQ 25 score up to 3 months after surgery
Time frame: Month 3
100 = Best score, 0 = Worst possible score
2 secondary outcomes
PSS score up to 3 months after surgery
Time frame: Month 3
SF-36 score up to 3 months after surgery
Time frame: Month 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
- Background: PubMed 21310012Rasmussen 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.
- Background: PubMed 20231012Ahn 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.
- Background: PubMed 34645962Damato 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lauriana SOLECKI, MD principal investigator
CHU de Besançon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quality of Life in people with Evisceration; Traumatic, Eye, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact SOLECKI Lauriana, MD (0033381668578, lsolecki@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score VFQ 25 score up to 3 months after surgery (time frame: Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05397743, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2022.