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

Completed

• Conditions: Dry Eye Syndrome; Dermatochalasis; Ptosis

• Registration Number: NCT02376556
• Lead Sponsor: Sheba Medical Center

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.

Study Timeline

• Study First Submitted: 2015-02-25
• Study Start: 2015-03
• Study First Submitted QC: 2015-03-02
• Study First Posted: 2015-03-03
• Primary Completion: 2018-03
• Study Completion: 2018-03
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-11
• Last Update Posted: 2019-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Objective assessment of dry eye syndrome	3 months postoperatively

Secondary Outcome Measures

Name	Time	Method
Subjective assessment of dry eye syndrome	3 months postoperatively

Trial Locations

Locations (1)

Sheba_Medical_Center; 🇮🇱 Ramat Gan, Israel