Upper eyelid blepharoplasty investigating 3D and functional outcomes

Rationale: 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 (aesthetic 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.
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 an observational study. 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.
Study population: All consecutive male and female healthy Caucasian patients between the age of 30 and 70 that are referred for an upper blepharoplasty to the department of Oral and Maxillofacial Surgery of the University Medical Center Groningen will be approached to join the study. For this study, we need to include 54 patients.
Intervention: The traditional group of patients will be treated with a blepharoplasty consisting of the resection of skin, a strip of the orbicularis oculi muscle and bipolar coagulation of septum and orbital fat. The alternative other group will be treated with a blepharoplasty consisting of resection of skin only. Functional outcomes will be measured pre- and postoperative. These consist of electrical activity of the frontal and peri-orbital muscles and peripheral vision. The presence and severity of dry eyes will be evaluated by using the Schirmer test, Break-Up Time, tear osmolarity and Lissamine green staining. Furthermore, 3D changes in volume will be measured. Also patients well-being will be measured by using the FACE-Q questionnaire, Ocular Surface Disease Index and the Headache Impact Test 6.
Main study parameters/endpoints: The primary endpoint is orbital change in volume. 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.

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. We hypothesize that these outcomes change after upper blepharoplasty and may or may not differ between two surgical techniques.

Preoperative and 2,6 and 12 months postoperative.