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Risk of Dry Eye Post Different Surgeries for Blepharoptosis Repair

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ClinicalTrials.gov Identifier: NCT02501187
Recruitment Status : Unknown
Verified April 2018 by Maya Eiger, Rabin Medical Center.
Recruitment status was:  Recruiting
First Posted : July 17, 2015
Last Update Posted : April 13, 2018
Sponsor:
Information provided by (Responsible Party):
Maya Eiger, Rabin Medical Center

Brief Summary:
Blepharoptosis, inferodisplacement of the upper eyelid, can be congenital or acquired. Acquired Blepharoptosis is usually aponeurotic, due to stretching or disinsertion of the levator aponeurosis. Treatment is surgical and can be performed by three common procedures - Levator advancement, Müller's muscle-conjunctival resection procedure and White line advancement. A number of reports inspected the possibility that Blepharoptosis repair procedures may cause deterioration in dry eye status. The investigators would like to assess whether there is a difference between the different procedures in their influence on dry eye status.

Condition or disease Intervention/treatment Phase
Blepharoptosis Procedure: Levator advancement Procedure: Müller's muscle-conjunctival resection procedure Procedure: White line advancement Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison Between Three Different Surgeries for Blepharoptosis Repair and Their Impact on Dry Eye Status
Actual Study Start Date : October 8, 2015
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Arm Intervention/treatment
Experimental: Patients operated for ptosis by levator advancement
patients undergoing surgical repair for aponeurotic ptosis by the procedure- levator advancement.
Procedure: Levator advancement
A transcutaneous procedure in which the Levator palpebrae aponeurosis is advanced and attached to the tarsus.

Experimental: Patients operated for ptosis by white line advancement
patients undergoing surgical repair for aponeurotic ptosis by the procedure- white line advancement
Procedure: White line advancement
A transconjunctival procedure in which the Levator palpebrae aponeurosis is advanced and attached to the tarsus.

Experimental: Patients operated for ptosis by Müller resection
patients undergoing surgical repair for aponeurotic ptosis by the procedure- Müller's muscle-conjunctival resection.
Procedure: Müller's muscle-conjunctival resection procedure
A transconjunctival procedure in which part of the muller muscle and conjunctiva are resected.




Primary Outcome Measures :
  1. Diagnosis of objective or subjective deterioration in dry eye status [ Time Frame: 6 months ]
    Dry eye status will be measured by a composite of tests, including Ocular surface disease index (OSDI) questionnaire (which indicates subjective status), and a number of objective tests - Shirmer test, Flurocein dye, Lissamine green dye and tear breakup time


Secondary Outcome Measures :
  1. Ptosis repair procedure success [ Time Frame: 6 months ]
    Success will be assessed by comparison of margin reflex distance1 (MRD1) measurement before and after surgery



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Ptosis which indicate surgical repair
  • The ptosis must be suitable for repair in any of the procedures

Exclusion Criteria:

  • Systemic disease which may cause ocular surface disease (eg Sjogren disease)
  • Previous orbital or eyelid surgery
  • Significantly dry eyes

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): NCT02501187


Contacts
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Contact: Maya Eiger, MD +972-3-9376107 mayae2@clalit.org.il

Locations
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Israel
Ophthalmology clinics, Rabin Medical Center Recruiting
Petach Tikva, Israel
Contact: Maya Eiger, MD    +972-3-9376017    mayae2@clalit.org.il   
Principal Investigator: Maya Eiger, MD         
Sponsors and Collaborators
Rabin Medical Center
Investigators
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Principal Investigator: Maya Eiger, MD Rabin Medical Center
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Responsible Party: Maya Eiger, Medical Doctor, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT02501187    
Other Study ID Numbers: Ptosis-01
First Posted: July 17, 2015    Key Record Dates
Last Update Posted: April 13, 2018
Last Verified: April 2018
Additional relevant MeSH terms:
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Blepharoptosis
Eyelid Diseases
Eye Diseases