ISRCTN - ISRCTN12000158: Functional and psychosocial benefits of blepharoplasty

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

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