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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

Tracking Information
First Submitted Date  ICMJE July 12, 2015
First Posted Date  ICMJE July 17, 2015
Last Update Posted Date April 13, 2018
Actual Study Start Date  ICMJE October 8, 2015
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2015)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 15, 2015)
Ptosis repair procedure success [ Time Frame: 6 months ]
Success will be assessed by comparison of margin reflex distance1 (MRD1) measurement before and after surgery
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Risk of Dry Eye Post Different Surgeries for Blepharoptosis Repair
Official Title  ICMJE Comparison Between Three Different Surgeries for Blepharoptosis Repair and Their Impact on Dry Eye Status
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Blepharoptosis
Intervention  ICMJE
  • Procedure: Levator advancement
    A transcutaneous procedure in which the Levator palpebrae aponeurosis is advanced and attached to the tarsus.
  • Procedure: Müller's muscle-conjunctival resection procedure
    A transconjunctival procedure in which part of the muller muscle and conjunctiva are resected.
  • Procedure: White line advancement
    A transconjunctival procedure in which the Levator palpebrae aponeurosis is advanced and attached to the tarsus.
Study Arms  ICMJE
  • Experimental: Patients operated for ptosis by levator advancement
    patients undergoing surgical repair for aponeurotic ptosis by the procedure- levator advancement.
    Intervention: Procedure: Levator advancement
  • Experimental: Patients operated for ptosis by white line advancement
    patients undergoing surgical repair for aponeurotic ptosis by the procedure- white line advancement
    Intervention: Procedure: White line advancement
  • Experimental: Patients operated for ptosis by Müller resection
    patients undergoing surgical repair for aponeurotic ptosis by the procedure- Müller's muscle-conjunctival resection.
    Intervention: Procedure: Müller's muscle-conjunctival resection procedure
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 15, 2015)
75
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2020
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02501187
Other Study ID Numbers  ICMJE Ptosis-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Maya Eiger, Rabin Medical Center
Study Sponsor  ICMJE Rabin Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Maya Eiger, MD Rabin Medical Center
PRS Account Rabin Medical Center
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP