Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02376556
Recruitment Status : Unknown
Verified June 2015 by Dr. Guy Ben-Simon, MD, Sheba Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : March 3, 2015
Last Update Posted : June 16, 2015
Sponsor:
Information provided by (Responsible Party):
Dr. Guy Ben-Simon, MD, 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.

Condition or disease
Dry Eye Syndrome Ptosis Dermatochalasis

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.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Prevalence of Dry Eye Syndrome Among Patients Who Underwent Upper Eyelids Blepharoplasty With and Without Muller Muscle Resection
Study Start Date : March 2015
Estimated Primary Completion Date : March 2017

Resource links provided by the National Library of Medicine


Group/Cohort
Blepharoplasty
patients undergoing upper eyelid blepharoplasty
blepharoplasty and muller muscle resection
patients undergoing a combined blepharoplasty and muller muscle resection surgery



Primary Outcome Measures :
  1. dry eye syndrome [ Time Frame: 3 months postoperatively ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02376556


Contacts
Layout table for location contacts
Contact: Guy J Ben Simon, MD 972-3-5302874 guybensimon@gmail.com

Locations
Layout table for location information
Israel
Sheba_Medical_Center
Ramat Gan, Israel, 52621
Sponsors and Collaborators
Sheba Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Guy J Ben Simon, MD Sheba Medical Center, Israel

Layout table for additonal information
Responsible Party: Dr. Guy Ben-Simon, MD, Head, Orbital, Ophthalmic Plastic & Lacrimal Surgery department, The Goldschleger Eye Institute, Sheba Medical Center, Tel Hashomer, Israel, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT02376556     History of Changes
Other Study ID Numbers: SHEBA-14-1496-GBS-CTIL
First Posted: March 3, 2015    Key Record Dates
Last Update Posted: June 16, 2015
Last Verified: June 2015

Keywords provided by Dr. Guy Ben-Simon, MD, Sheba Medical Center:
Dry eye syndrome
Blepharoplasty
Muller muscle resection surgery

Additional relevant MeSH terms:
Layout table for MeSH terms
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Syndrome
Cutis Laxa
Disease
Pathologic Processes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Connective Tissue Diseases
Skin Diseases