Functional and psychosocial benefits of blepharoplasty

ISRCTN	ISRCTN12000158
DOI	https://doi.org/10.1186/ISRCTN12000158
Protocol serial number	N/A
Sponsor	Thy-Mors Hospital (Denmark)
Funder	Thy-Mors Hospital (Denmark)

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 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

Contact information

Dr Janos Hargitai
Scientific

Højtoftevej 2
Thisted
7700
Denmark

Email	janos.hargitai@rn.dk

Study information

Primary study design	Observational
Study design	Observational cohort study
Secondary study design	Cohort study
Study type	Participant information sheet
Scientific title	Functional and psychosocial benefits of blepharoplasty - evaluated by objective and subjective outcome measures
Study objectives	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(s)	Regional Ethics Committee of North Jutland (Den Videnskabsetiske Komité for Region Nordjylland), 08/10/2013
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	01/03/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	50
Total final enrolment	45
Key inclusion criteria	Patients aged over 18 years with dermatochalasis meeting the Danish visitation guidelines for blepharoplasty on a functional indication
Key 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
Date of first enrolment	01/03/2014
Date of final enrolment	01/03/2015

Locations

Countries of recruitment

Denmark

Study participating centre

Højtoftevej 2

Thisted
7700
Denmark

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not 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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

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