Comparison Between Different Surgical Approaches for the Treatment of INVOLUTIONAL PTOSIS

Clalit Health Services

Status: Unknown

Conditions: Involutional Ptosis

Treatments: Procedure: Blepharoptosis repair

Study type: Interventional

Funder types: Other

Identifiers

NCT03373812

MMC17230-17CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

anterior approach

Active Comparator group

Description:

patients having involutional ptosis undergoing anterior approach surgical ptosis repair (Levator advancement)

Treatment:

Procedure: Blepharoptosis repair

posterior approach

Active Comparator group

Description:

patients having involutional ptosis undergoing posterior approach surgical ptosis repair (mullerectomy)

Treatment:

Procedure: Blepharoptosis repair