The aim of this study is to objectively assess 3D and functional outcomes of upper blepharoplasty on periorbital volume, dry eyes, peripheral vision, electrical activity of the frontal muscles and wellbeing in two different surgical techniques.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
blefarochalasis, huidoverschot van de bovenoogleden
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is orbital change in volume.
Secondary outcome
Secondary outcomes are electrical activity of the frontal and orbicularis oculi
muscles, peripheral vision, presence and severity of dry eyes, quality of life
and wellbeing.
Background summary
Blepharoplasty of the upper eyelids is one of the most commonly performed
surgical procedures in aesthetic surgery. This surgery may be performed for
aesthetic reasons, but also for functional indications. Based on the existing
literature, the outcomes of an upper blepharoplasty might depend on the
peri-orbital volume and the surgical technique applied. The traditional
technique of upper blepharoplasty consists of the resection of skin and a strip
of the orbicularis oculi muscle, and coagulation of fat. A common alternative
technique involves the removal of skin only (alternative). The outcomes
(esthetic and functional) between these techniques may vary. Both techniques
are widely used in daily practice. However, there is yet no consensus about
which technique is preferable.
Study objective
The aim of this study is to objectively assess 3D and functional outcomes of
upper blepharoplasty on periorbital volume, dry eyes, peripheral vision,
electrical activity of the frontal muscles and wellbeing in two different
surgical techniques.
Study design
The study design is a clincial trial. Patients are randomized in the
*traditional* (resection of skin and strip of the orbicularis oculi muscle)or
*alternative* (skin only ) blepharoplasty treatment group. The investigators
and patients are blinded during the study. Patients undergo a series of
functional tests and 3D photography pre- and postoperatively. The follow up is
12 months.
Intervention
Patients undergo a blepharoplasty.
Study burden and risks
Both surgical techniques are common techniques for a upper blepharoplasty,
widely used and considered not to be harmful. Specific for this study, the
patient have to undergo a series of non-invasive tests. Completing these tests
cost the patients 45 minutes extra per visit. During the one year follow-up,
the participants have to visit the clinic 4 times of which 2 visits are
combined their regular control appointments (standard care).
Hanzeplein 1
Groningen 9700 RB
NL
Hanzeplein 1
Groningen 9700 RB
NL
Listed location countries
Age
Inclusion criteria
- Blepharochalasis of both eyes
- Age between 30 and 60
- Caucasian
- Both male and female patients are included
- Correction of vision between -6 and +6
- Vision of 0.5 or better (with correction)
- Fluent in Dutch
- Legally capable
Exclusion criteria
- Protruding medial fat compartment
- Ocular trauma in past
- Trauma of the orbital region in the past
- A medical history of eyelid surgery or surgery in the region of the eyebrows.
- Any current ophthalmic disease that could interfere with the ophthalmic tests
- Horner syndrome
- Blepharoptosis
- Graves* disease
- Myasthenia Gravis
- Recent (in the past 6 months) botulin toxin treatment in the upper face
- Nasolacrimal duct obstruction
- Epilepsy
- Retinal defects/diseases that cause visual field defects
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL62635.042.17 |