Comparison Between Different Surgical Approaches for the Treatment of INVOLUTIONAL PTOSIS

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.

Study Overview

• Status: Unknown
• Conditions: Involutional Ptosis
• Intervention / Treatment: Procedure: Blepharoptosis repair

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Arie Nemet, Prof. (MD); Phone Number: +972-9-7471527; Email: nemet.arik@gmail.com
• Study Contact Backup: Name: Tal Sharon, Dr.(MD); Phone Number: +972-544831188 +972-7472154; Email: tal.sharon.p@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Meir Medical Center
• Investigators: Principal Investigator: Arie Nemet, Prof. (MD), ophthalmology depertmant, MeirMc, Israel

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2018
• Primary Completion (Anticipated): January 1, 2019
• Study Completion (Anticipated): January 1, 2020

Study Registration Dates

• First Submitted: December 4, 2017
• First Submitted That Met QC Criteria: December 13, 2017
• First Posted (Actual): December 14, 2017

Study Record Updates

• Last Update Posted (Actual): December 14, 2017
• Last Update Submitted That Met QC Criteria: December 13, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse
• Other Study ID Numbers: MMC17230-17CTIL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No