Risk of Dry Eye Post Different Surgeries for Blepharoptosis Repair

NCT02501187 | Unknown

• 1 other identifier: Ptosis-01
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

Blepharoptosis, inferodisplacement of the upper eyelid, can be congenital or acquired. Acquired Blepharoptosis is usually aponeurotic, due to stretching or disinsertion of the levator aponeurosis. Treatment is surgical and can be performed by three common procedures - Levator advancement, Müller's muscle-conjunctival resection procedure and White line advancement. A number of reports inspected the possibility that Blepharoptosis repair procedures may cause deterioration in dry eye status. The investigators would like to assess whether there is a difference between the different procedures in their influence on dry eye status.

Conditions

Blepharoptosis

Outcome Measures

Primary Outcomes (1)

• Diagnosis of objective or subjective deterioration in dry eye status

  Dry eye status will be measured by a composite of tests, including Ocular surface disease index (OSDI) questionnaire (which indicates subjective status), and a number of objective tests - Shirmer test, Flurocein dye, Lissamine green dye and tear breakup time

  6 months

Secondary Outcomes (1)

• Ptosis repair procedure success

  6 months

Study Arms (3)

Patients operated for ptosis by levator advancement

EXPERIMENTAL

patients undergoing surgical repair for aponeurotic ptosis by the procedure- levator advancement.

Procedure: Levator advancement

Patients operated for ptosis by white line advancement

EXPERIMENTAL

patients undergoing surgical repair for aponeurotic ptosis by the procedure- white line advancement

Procedure: White line advancement

Patients operated for ptosis by Müller resection

EXPERIMENTAL

patients undergoing surgical repair for aponeurotic ptosis by the procedure- Müller's muscle-conjunctival resection.

Procedure: Müller's muscle-conjunctival resection procedure

Interventions

Levator advancement PROCEDURE

A transcutaneous procedure in which the Levator palpebrae aponeurosis is advanced and attached to the tarsus.

Patients operated for ptosis by levator advancement

Müller's muscle-conjunctival resection procedure PROCEDURE

A transconjunctival procedure in which part of the muller muscle and conjunctiva are resected.

Patients operated for ptosis by Müller resection

White line advancement PROCEDURE

A transconjunctival procedure in which the Levator palpebrae aponeurosis is advanced and attached to the tarsus.

Patients operated for ptosis by white line advancement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ptosis which indicate surgical repair
• The ptosis must be suitable for repair in any of the procedures

You may not qualify if:

• Systemic disease which may cause ocular surface disease (eg Sjogren disease)
• Previous orbital or eyelid surgery
• Significantly dry eyes

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Ophthalmology clinics, Rabin Medical Center

Petah Tikva, Israel

RECRUITING

MeSH Terms

Conditions

Blepharoptosis

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases

Study Officials

• Maya Eiger, MD

  Rabin Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maya Eiger, MD

CONTACT

+972-3-9376107; mayae2@clalit.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: July 12, 2015
• First Posted: July 17, 2015
• Study Start: October 8, 2015
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: April 13, 2018

Record last verified: 2018-04

Locations

IL (1)