The Effect of Eyelid Surgery on Dry Eye - a Prospective Study
The Prevalence of Dry Eye Syndrome Among Patients Who Underwent Upper Eyelids Blepharoplasty With and Without Muller Muscle Resection
1 other identifier
observational
54
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2015
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2015
CompletedStudy Start
First participant enrolled
March 1, 2015
CompletedFirst Posted
Study publicly available on registry
March 3, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2018
CompletedOctober 15, 2019
October 1, 2019
3 years
February 25, 2015
October 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective assessment of dry eye syndrome
3 months postoperatively
Secondary Outcomes (1)
Subjective assessment of dry eye syndrome
3 months postoperatively
Study Arms (2)
Blepharoplasty
patients undergoing upper eyelid blepharoplasty
blepharoplasty and muller muscle resection
patients undergoing a combined blepharoplasty and muller muscle resection surgery
Eligibility Criteria
Patients who are referred for blepharoplasty with or without muller muscle resection in the oculoplastic clinic in our institution
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sheba_Medical_Center
Ramat Gan, 52621, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Guy J Ben Simon, MD
Sheba Medical Center
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head, Orbital, Ophthalmic Plastic & Lacrimal Surgery department, The Goldschleger Eye Institute, Sheba Medical Center, Tel Hashomer, Israel
Study Record Dates
First Submitted
February 25, 2015
First Posted
March 3, 2015
Study Start
March 1, 2015
Primary Completion
March 1, 2018
Study Completion
March 1, 2018
Last Updated
October 15, 2019
Record last verified: 2019-10