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OpenTrials
Completed

NCT Number: NCT02376556

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Objective assessment of dry eye syndrome

    Time frame: 3 months postoperatively

Secondary outcomes

  1. Subjective assessment of dry eye syndrome

    Time frame: 3 months postoperatively

Sponsors and collaborators

Lead sponsor

Sheba Medical Center

Other Gov

Registry information

Official study title

The Prevalence of Dry Eye Syndrome Among Patients Who Underwent Upper Eyelids Blepharoplasty With and Without Muller Muscle Resection

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Mar 3, 2015
Registry last updated
Oct 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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