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Comparison Between Different Surgical Approaches for the Treatment of INVOLUTIONAL PTOSIS

Primary Purpose

Involutional Ptosis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Blepharoptosis repair
Sponsored by
Meir Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Involutional Ptosis

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Involutional ptosis
  • No previous eyelid surgery

Exclusion Criteria:

  • Previous eyelid surgery or trauma
  • Congenital ptosis
  • Previous glaucoma filtrartion surgery
  • Unwillingness for six months followup

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    anterior approach

    posterior approach

    Arm Description

    patients having involutional ptosis undergoing anterior approach surgical ptosis repair (Levator advancement)

    patients having involutional ptosis undergoing posterior approach surgical ptosis repair (mullerectomy)

    Outcomes

    Primary Outcome Measures

    MRD1
    Distance in millimeters between corneal light reflex and upper eyelid margin
    surgery duration
    Time from first incision to last suture (in minutes)
    Levator function
    change (in millimeters) in upper eyelid position from downgaze to maximal upgaze

    Secondary Outcome Measures

    Need for additional eyelid surgery
    Any need for oculoplastic additional surgical interventions (Descriptive)
    Eyelid or ocular secondary disease
    Descriptive

    Full Information

    First Posted
    December 4, 2017
    Last Updated
    December 13, 2017
    Sponsor
    Meir Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03373812
    Brief Title
    Comparison Between Different Surgical Approaches for the Treatment of INVOLUTIONAL PTOSIS
    Official Title
    Comparison Between Different Surgical Approaches for the Treatment of INVOLUTIONAL PTOSIS
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 1, 2018 (Anticipated)
    Primary Completion Date
    January 1, 2019 (Anticipated)
    Study Completion Date
    January 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Meir Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Involutional ptosis is a known eyelid pathology in which the eyelid margin obscures part of the visual axis (MRD1).Patients usually complains of visual field disturbance, deterioration in quality of life and a poor cosmetic appearance. In clinical practice, two main surgical approaches are performed to the repair of involutional ptosis: anterior approach - skin incision and levator muscle insertion advancement. posterior approach - eyelid reversion and tarsectomy Both approaches has its pro's and con's, but to this date, no solid evidence exists to prove which of these techniques is superior in manner of anatomical and functional results. in this prospective study, patients with involutional ptosis will be randomized to each of surgical approaches groups, parameters concerning surgical and post surgical periods will be evaluated.
    Detailed Description
    Involutional ptosis is a known eyelid pathology in which the eyelid margin obscures part of the visual axis (MRD1).Patients usually complains of visual field disturbance, deterioration in quality of life and a poor cosmetic appearance. In clinical practice, two main surgical approaches are performed to the repair of involutional ptosis: anterior approach - skin incision and levator muscle insertion advancement. posterior approach - eyelid reversion and tarsectomy Both approaches has its pro's and con's, but to this date, no solid evidence exists to prove which of these techniques is superior in manner of anatomical and functional results. in this prospective study, patients with involutional ptosis will be randomized to each of surgical approaches groups, parameters concerning surgical and post surgical periods will be evaluated.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Involutional Ptosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    anterior approach
    Arm Type
    Active Comparator
    Arm Description
    patients having involutional ptosis undergoing anterior approach surgical ptosis repair (Levator advancement)
    Arm Title
    posterior approach
    Arm Type
    Active Comparator
    Arm Description
    patients having involutional ptosis undergoing posterior approach surgical ptosis repair (mullerectomy)
    Intervention Type
    Procedure
    Intervention Name(s)
    Blepharoptosis repair
    Intervention Description
    levator advancement or mullerectomy
    Primary Outcome Measure Information:
    Title
    MRD1
    Description
    Distance in millimeters between corneal light reflex and upper eyelid margin
    Time Frame
    6 months
    Title
    surgery duration
    Description
    Time from first incision to last suture (in minutes)
    Time Frame
    3 hours
    Title
    Levator function
    Description
    change (in millimeters) in upper eyelid position from downgaze to maximal upgaze
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Need for additional eyelid surgery
    Description
    Any need for oculoplastic additional surgical interventions (Descriptive)
    Time Frame
    6 months
    Title
    Eyelid or ocular secondary disease
    Description
    Descriptive
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Involutional ptosis No previous eyelid surgery Exclusion Criteria: Previous eyelid surgery or trauma Congenital ptosis Previous glaucoma filtrartion surgery Unwillingness for six months followup
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Arie Nemet, Prof. (MD)
    Phone
    +972-9-7471527
    Email
    nemet.arik@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Tal Sharon, Dr.(MD)
    Phone
    +972-7472154
    Ext
    +972-544831188
    Email
    tal.sharon.p@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Arie Nemet, Prof. (MD)
    Organizational Affiliation
    ophthalmology depertmant, MeirMc, Israel
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    27429227
    Citation
    Patel RM, Aakalu VK, Setabutr P, Putterman AM. Efficacy of Muller's Muscle and Conjunctiva Resection With or Without Tarsectomy for the Treatment of Severe Involutional Blepharoptosis. Ophthalmic Plast Reconstr Surg. 2017 Jul/Aug;33(4):273-278. doi: 10.1097/IOP.0000000000000748.
    Results Reference
    background
    PubMed Identifier
    22186506
    Citation
    Chang S, Lehrman C, Itani K, Rohrich RJ. A systematic review of comparison of upper eyelid involutional ptosis repair techniques: efficacy and complication rates. Plast Reconstr Surg. 2012 Jan;129(1):149-157. doi: 10.1097/PRS.0b013e318230a1c7. Erratum In: Plast Reconstr Surg. 2015 May;135(5):1507.
    Results Reference
    background
    PubMed Identifier
    25719375
    Citation
    Sohrab MA, Lissner GS. Comparison of Fasanella-Servat and Small-Incision Techniques for Involutional Ptosis Repair. Ophthalmic Plast Reconstr Surg. 2016 Mar-Apr;32(2):98-101. doi: 10.1097/IOP.0000000000000417.
    Results Reference
    background
    PubMed Identifier
    15953636
    Citation
    Ben Simon GJ, Joseph J, Lee S, Schwarcz RM, McCann JD, Goldberg RA. External versus endoscopic dacryocystorhinostomy for acquired nasolacrimal duct obstruction in a tertiary referral center. Ophthalmology. 2005 Aug;112(8):1463-8. doi: 10.1016/j.ophtha.2005.03.015.
    Results Reference
    background
    PubMed Identifier
    8437835
    Citation
    Liu D. Ptosis repair by single suture aponeurotic tuck. Surgical technique and long-term results. Ophthalmology. 1993 Feb;100(2):251-9. doi: 10.1016/s0161-6420(93)31662-3.
    Results Reference
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    Comparison Between Different Surgical Approaches for the Treatment of INVOLUTIONAL PTOSIS

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