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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02376556
Other study ID # SHEBA-14-1496-GBS-CTIL
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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