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

NCT ID: NCT02376556

Last Updated: 2019-10-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 54 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2018-03-31

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.

Conditions

Dry Eye Syndrome; Ptosis; Dermatochalasis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Blepharoplasty

patients undergoing upper eyelid blepharoplasty

No interventions assigned to this group

blepharoplasty and muller muscle resection

patients undergoing a combined blepharoplasty and muller muscle resection surgery

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Guy Ben Simon

Head, Orbital, Ophthalmic Plastic & Lacrimal Surgery department, The Goldschleger Eye Institute, Sheba Medical Center, Tel Hashomer, Israel

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guy J Ben Simon, MD

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Locations

Sheba_Medical_Center

Ramat Gan, , Israel

Countries

Israel

Other Identifiers

SHEBA-14-1496-GBS-CTIL

Identifier Type: -

Identifier Source: org_study_id