Clinical trial NCT03373812: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Involutional Ptosis
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2017-12-14
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: MRD1
timeFrame: 6 months
measure: surgery duration
timeFrame: 3 hours
measure: Levator function
timeFrame: 6 months
Secondary outcomes:
measure: Need for additional eyelid surgery
timeFrame: 6 months
measure: Eyelid or ocular secondary disease
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: ophthalmology depertmant, MeirMc, Israel
name: Arie Nemet, Prof. (MD)
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.