Clinical trial NCT02376556: The Effect of Eyelid Surgery on Dry Eye - a Prospective Study
Official title: The Prevalence of Dry Eye Syndrome Among Patients Who Underwent Upper Eyelids Blepharoplasty With and Without Muller Muscle Resection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dry Eye Syndrome
Ptosis
Dermatochalasis
Keywords: Dry eye syndrome
Blepharoplasty
Muller muscle resection surgery
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2015-03-03
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are referred for blepharoplasty with or without muller muscle resection in the oculoplastic clinic in our institution

Brief summary: The investigators aim to assess the effect of blepharoplasty with or without muller muscle resection on the symptoms of dry eye syndrome. this will be an observational study in which patients undergoing the aforementioned surgeries will be followed up and monitored for dry eye symptoms.

Detailed description: Patients who are referred for blepharoplasty with or without muller muscle resection in the oculoplastic clinic in the investigators institution, will be offered to participate in the study. After filling and informed consent form, patients recruited will fill in a questionnaire about dry eye symptoms, and will be examined by an ophthalmologist for visual acuity, intra ocular pressure, anterior segment examination using a slit lamp biomicroscopy, schirmer test, tear break up time assessment and tear osmolarity. These are all standard examination in ophthalmology. The surgical procedure planned to correct the eyelid pathology will not be affected by the results of these examinations.

The same combination of ophthalmic examination will by done on postoperative follow-up examination 1 week, 1 month and 3 months after the surgery. Dry eye questionnaire will be filled in by the patients on postoperative follow-up examination 1 month and 3 months after the surgery.

This data will help us assess the effect of these common surgical procedures on dry eye symptoms.

Eligibility criteria: Inclusion Criteria:

* patients who are referred for blepharoplasty with or without muller muscle resection in the oculoplastic clinic in our institution
* no other ophthalmic procedures planned for the patient in study period
* ability to undergo full ophthalmic examination as stated in the study protocol
* Ability to complete the dry eye questionnaire
* ability to sign an informed consent form

Exclusion Criteria:

* previous eyelid surgery
* other orbital or lacrimal gland disease
* concurrent use of contact lenses
* concurrent use of Restasis
* previous glaucoma surgery
* use of punctual plugs
* pregnant or nursing women

Primary outcomes:
measure: Objective assessment of dry eye syndrome
timeFrame: 3 months postoperatively
Secondary outcomes:
measure: Subjective assessment of dry eye syndrome
timeFrame: 3 months postoperatively
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba_Medical_Center
Study officials:
affiliation: Sheba Medical Center
name: Guy J Ben Simon, MD
role: PRINCIPAL_INVESTIGATOR
References: