Functional and psychosocial benefits of blepharoplasty

ISRCTN ISRCTN12000158
DOI https://doi.org/10.1186/ISRCTN12000158
Secondary identifying numbers N/A
Submission date
27/02/2014
Registration date
27/03/2014
Last edited
25/06/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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 study’s 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

Contact information

Dr Janos Hargitai
Scientific

Højtoftevej 2
Thisted
7700
Denmark

Email janos.hargitai@rn.dk

Study information

Study designObservational cohort study
Primary study designObservational
Secondary study designCohort study
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleFunctional and psychosocial benefits of blepharoplasty - evaluated by objective and subjective outcome measures
Study objectivesTo 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(s)Regional Ethics Committee of North Jutland (Den Videnskabsetiske Komité for Region Nordjylland), 08/10/2013
Health condition(s) or problem(s) studiedDermatochalasis, blepharoplasty
InterventionUpper 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 typeOther
Primary outcome measure1. 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 measures1. 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 study start date01/03/2014
Completion date01/03/2015

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants50
Total final enrolment45
Key inclusion criteriaPatients aged over 18 years with dermatochalasis meeting the Danish visitation guidelines for blepharoplasty on a functional indication
Key exclusion criteria1. Aged under 18 years
2. Inability or unwillingness to answer the questionnaires or attend the 3-month follow-up
3. Visual acuity < 0.5
Date of first enrolment01/03/2014
Date of final enrolment01/03/2015

Locations

Countries of recruitment

  • Denmark

Study participating centre

Højtoftevej 2
Thisted
7700
Denmark

Sponsor information

Thy-Mors Hospital (Denmark)
Hospital/treatment centre

Højtoftevej 2
Thisted
7700
Denmark

Email janos.hargitai@rn.dk

Funders

Funder type

Hospital/treatment centre

Thy-Mors Hospital (Denmark)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/12/2017 25/06/2020 Yes No

Editorial Notes

25/06/2020: Publication reference and total final enrolment number added.