Involutional Ptosis Clinical Trial
Official title:
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.
| Status | Not yet recruiting |
| Enrollment | 120 |
| Est. completion date | January 2020 |
| Est. primary completion date | January 1, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 100 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Meir Medical Center |
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. — View 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):149-57. doi: 10.1097/PRS.0b013e318230a1c7. Review. Erratum in: Plast Reconstr Surg. 2015 May;135(5):1507. — View Citation
Liu D. Ptosis repair by single suture aponeurotic tuck. Surgical technique and long-term results. Ophthalmology. 1993 Feb;100(2):251-9. — View 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. Ophthal Plast Reconstr Surg. 2017 Jul/Aug;33(4):273-278. doi: 10.1097/IOP.0000000000000748. — View Citation
Sohrab MA, Lissner GS. Comparison of Fasanella-Servat and Small-Incision Techniques for Involutional Ptosis Repair. Ophthal Plast Reconstr Surg. 2016 Mar-Apr;32(2):98-101. doi: 10.1097/IOP.0000000000000417. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | MRD1 | Distance in millimeters between corneal light reflex and upper eyelid margin | 6 months | |
| Primary | surgery duration | Time from first incision to last suture (in minutes) | 3 hours | |
| Primary | Levator function | change (in millimeters) in upper eyelid position from downgaze to maximal upgaze | 6 months | |
| Secondary | Need for additional eyelid surgery | Any need for oculoplastic additional surgical interventions (Descriptive) | 6 months | |
| Secondary | Eyelid or ocular secondary disease | Descriptive | 6 months |