Comparison Between Different Surgical Approaches for the Treatment of INVOLUTIONAL PTOSIS

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison Between Different Surgical Approaches for the Treatment of INVOLUTIONAL PTOSIS

Conditions
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Involutional Ptosis

Intervention / Treatment
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* Procedure: Blepharoptosis repair


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: anterior approach<br>patients having involutional ptosis undergoing anterior approach surgical ptosis repair (Levator advancement) | Procedure: Blepharoptosis repair<br>* levator advancement or mullerectomy<br>|
| Active Comparator: posterior approach<br>patients having involutional ptosis undergoing posterior approach surgical ptosis repair (mullerectomy) | Procedure: Blepharoptosis repair<br>* levator advancement or mullerectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRD1 | Distance in millimeters between corneal light reflex and upper eyelid margin | 6 months | 
| surgery duration | Time from first incision to last suture (in minutes) | 3 hours | 
| Levator function | change (in millimeters) in upper eyelid position from downgaze to maximal upgaze | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for additional eyelid surgery | Any need for oculoplastic additional surgical interventions (Descriptive) | 6 months | 
| Eyelid or ocular secondary disease | Descriptive | 6 months |