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
About this trial
This is an interventional treatment trial for Involutional Ptosis
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
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
NCT ID
NCT03373812
First Posted
December 4, 2017
Last Updated
December 13, 2017
Sponsor
Meir Medical Center
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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