Comparison Between Different Surgical Approaches for the Treatment of INVOLUTIONAL PTOSIS
NCT ID: NCT03373812
Last Updated: 2017-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
120 participants
INTERVENTIONAL
2018-01-01
2020-01-31
Brief Summary
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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
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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anterior approach
patients having involutional ptosis undergoing anterior approach surgical ptosis repair (Levator advancement)
Blepharoptosis repair
levator advancement or mullerectomy
posterior approach
patients having involutional ptosis undergoing posterior approach surgical ptosis repair (mullerectomy)
Blepharoptosis repair
levator advancement or mullerectomy
Interventions
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Blepharoptosis repair
levator advancement or mullerectomy
Eligibility Criteria
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Inclusion Criteria
* No previous eyelid surgery
Exclusion Criteria
* Congenital ptosis
* Previous glaucoma filtrartion surgery
* Unwillingness for six months followup
18 Years
100 Years
ALL
No
Sponsors
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Meir Medical Center
OTHER
Responsible Party
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Arie Nemet
Professor
Principal Investigators
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Arie Nemet, Prof. (MD)
Role: PRINCIPAL_INVESTIGATOR
ophthalmology depertmant, MeirMc, Israel
Central Contacts
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References
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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.
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.
Other Identifiers
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MMC17230-17CTIL
Identifier Type: -
Identifier Source: org_study_id