Comparison Between Different Surgical Approaches for the Treatment of INVOLUTIONAL PTOSIS

Not Applicable

• Conditions: Involutional Ptosis
• Interventions: Procedure: Blepharoptosis repair

• Registration Number: NCT03373812
• Lead Sponsor: Meir Medical Center

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:

1. anterior approach - skin incision and levator muscle insertion advancement.

2. 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:

1. anterior approach - skin incision and levator muscle insertion advancement.

2. 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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2017-12
• Study First Submitted: 2017-12-04
• Study First Submitted QC: 2017-12-13
• Last Update Submitted: 2017-12-13
• Study First Posted: 2017-12-14
• Last Update Posted: 2017-12-14
• Study Start: 2018-01-01
• Primary Completion: 2019-01-01
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Involutional ptosis
• No previous eyelid surgery

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
anterior approach	Blepharoptosis repair	patients having involutional ptosis undergoing anterior approach surgical ptosis repair (Levator advancement)
posterior approach	Blepharoptosis repair	patients having involutional ptosis undergoing posterior approach surgical ptosis repair (mullerectomy)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Need for additional eyelid surgery	6 months	Any need for oculoplastic additional surgical interventions (Descriptive)
Eyelid or ocular secondary disease	6 months	Descriptive