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Comparison Between Different Surgical Approaches for the Treatment of INVOLUTIONAL PTOSIS

Comparison Between Different Surgical Approaches for the Treatment of INVOLUTIONAL PTOSIS

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03373812
Enrollment
120
Registered
2017-12-14
Start date
2018-01-01
Completion date
2020-01-31
Last updated
2017-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Involutional Ptosis

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.

Interventions

levator advancement or mullerectomy

Sponsors

Meir Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
MRD16 monthsDistance in millimeters between corneal light reflex and upper eyelid margin
surgery duration3 hoursTime from first incision to last suture (in minutes)
Levator function6 monthschange (in millimeters) in upper eyelid position from downgaze to maximal upgaze

Secondary

MeasureTime frameDescription
Need for additional eyelid surgery6 monthsAny need for oculoplastic additional surgical interventions (Descriptive)
Eyelid or ocular secondary disease6 monthsDescriptive

Contacts

Primary ContactArie Nemet, Prof. (MD)
nemet.arik@gmail.com+972-9-7471527
Backup ContactTal Sharon, Dr.(MD)
tal.sharon.p@gmail.com+972-7472154

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026