The Effect of Eyelid Surgery on Dry Eye - a Prospective Study

Dry Eye Syndrome Clinical Trial

Official title:

The Prevalence of Dry Eye Syndrome Among Patients Who Underwent Upper Eyelids Blepharoplasty With and Without Muller Muscle Resection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02376556
• Other study ID #: SHEBA-14-1496-GBS-CTIL
• Status: Completed
• Start date: March 2015
• Est. completion date: March 2018

Study information

• Verified date: October 2019
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Dermatochalasis
• Dry Eye Syndrome
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Ptosis
• Syndrome

Locations

Country	Name	City	State
Israel	Sheba_Medical_Center	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective assessment of dry eye syndrome		3 months postoperatively
Secondary	Subjective assessment of dry eye syndrome		3 months postoperatively