Plain English Summary
Background and study aims
Removing excess skin from the upper eyelids (dermatochalasis) is one of the most commonly performed eyelid surgeries in Denmark. Patients who are referred for surgery may complain of heavy eyelids, headache due to permanent lifting of the forehead, and compromised visual fields. The increasing cost of public healthcare has made it necessary to apply a new guideline to distinguish patients who are entitled to undergo a surgery subsidized by the national healthcare system. However, the guideline itself states that it is rather complicated to apply the same criteria for every single individual. Therefore, this study aims to provide a better understanding of the functional and social benefits of this eyelid surgery. This way we can hopefully apply better and more individualized criteria for admittance for eyelid surgery in a public hospital setting.
Who can participate?
Patients aged over 18 years with dermatochalasis referred by an ophthalmologist or primary physician.
What does the study involve?
The study involves a regular eye assessment along with photo documentation and visual field testing. Patients will receive a questionnaire discussing the functional and social impact of their heavy eyelids. Surgeons will remove the excess skin from the upper eyelids. 3 months after surgery patients will have a control eye examination, photo documentation and visual field testing. Patient will also fill out the same questionnaire 3 months after the operation.
What are the possible benefits and risks of participating?
The possible benefits for the patient are an extended eye examination and an extra control assessment at 3 months after surgery. The studys risk does not exceed the risk of a regular skin removal operation (blepharoplasty).
Where is the study run from?
Our study will run at the Department of Ophthalmology, Thy-Mors Hospital in Thisted, Denmark.
When is the study starting and how long is it expected to run for?
The study will run from March 2014 to March 2015.
Who is funding the study?
The study is fully financed by the Department of Ophthalmology, Thy-Mors Hospital, Denmark.
Who is the main contact?
Janos Hargitai
janos.hargitai@rn.dk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Janos Hargitai
ORCID ID
Contact details
Højtoftevej 2
Thisted
7700
Denmark
-
janos.hargitai@rn.dk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Functional and psychosocial benefits of blepharoplasty - evaluated by objective and subjective outcome measures
Acronym
Study hypothesis
To investigate the functional and psychosocial benefits of blepharoplasty, in order to evaluate the visitation guidelines for blepharoplasty from the Danish Health and Medicines Authority.
Ethics approval
Regional Ethics Committee of North Jutland (Den Videnskabsetiske Komité for Region Nordjylland), 08/10/2013
Study design
Observational cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Dermatochalasis, blepharoplasty
Intervention
Upper eyelid blepharoplasty
Before surgery and 3 months after surgery:
1. Questionnaire concerning the functional and psychosocial impact of their eyelids
2. Standard eye exam including visual acuity measured using the Snellen Chart, slit lamp examination and indirect ophthalmoscopy
3. Photographic documentation using a normal camera and the infrared camera of the Spectralis OCT scanner.
Measurements of the eye include marginal reflex distance (MRD), eye fissure height, eye fissure width, upper lid sulcus height, upper lid height, iris diameter and upper iris radius visible
4. Automatic perimetry using the blepharoptosis program
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. Change in eyelid morphology after surgery
2. Change in visual field after surgery
Outcome measures will be assessed at baseline (surgery day) and 3 months after the surgery.
Secondary outcome measures
1. Change in functional problems caused by dermatochalasis after surgery
2. Change in psychosocial problems causes by dermatochalasis after surgery
3. Patient satisfaction compared to change in MRD, change in functional problems, change in psychosocial problems and change in visual field
Outcome measures will be assessed at baseline (surgery day) and 3 months after the surgery.
Overall trial start date
01/03/2014
Overall trial end date
01/03/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients aged over 18 years with dermatochalasis meeting the Danish visitation guidelines for blepharoplasty on a functional indication
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
50
Total final enrolment
45
Participant exclusion criteria
1. Aged under 18 years
2. Inability or unwillingness to answer the questionnaires or attend the 3-month follow-up
3. Visual acuity < 0.5
Recruitment start date
01/03/2014
Recruitment end date
01/03/2015
Locations
Countries of recruitment
Denmark
Trial participating centre
Højtoftevej 2
Thisted
7700
Denmark
Sponsor information
Organisation
Thy-Mors Hospital (Denmark)
Sponsor details
Højtoftevej 2
Thisted
7700
Denmark
-
janos.hargitai@rn.dk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Thy-Mors Hospital (Denmark)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2017 results in https://pubmed.ncbi.nlm.nih.gov/28205342/ (added 25/06/2020)