Risk of Dry Eye Post Different Surgeries for Blepharoptosis Repair

Comparison Between Three Different Surgeries for Blepharoptosis Repair and Their Impact on Dry Eye Status

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.

Study Overview

• Status: Unknown
• Conditions: Blepharoptosis
• Intervention / Treatment: Procedure: Levator advancement; Procedure: White line advancement; Procedure: Müller's muscle-conjunctival resection procedure

• Study Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maya Eiger, MD; Phone Number: +972-3-9376107; Email: mayae2@clalit.org.il

Study Locations

• Israel
  • Petach Tikva, Israel
    • Recruiting
    • Ophthalmology clinics, Rabin Medical Center
    • Contact: Maya Eiger, MD; Phone Number: +972-3-9376017; Email: mayae2@clalit.org.il
    • Principal Investigator: Maya Eiger, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients operated for ptosis by levator advancement; patients undergoing surgical repair for aponeurotic ptosis by the procedure- levator advancement.	Procedure: Levator advancement; A transcutaneous procedure in which the Levator palpebrae aponeurosis is advanced and attached to the tarsus.
Experimental: Patients operated for ptosis by white line advancement; patients undergoing surgical repair for aponeurotic ptosis by the procedure- white line advancement	Procedure: White line advancement; A transconjunctival procedure in which the Levator palpebrae aponeurosis is advanced and attached to the tarsus.
Experimental: Patients operated for ptosis by Müller resection; patients undergoing surgical repair for aponeurotic ptosis by the procedure- Müller's muscle-conjunctival resection.	Procedure: Müller's muscle-conjunctival resection procedure; A transconjunctival procedure in which part of the muller muscle and conjunctiva are resected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ptosis repair procedure success	Success will be assessed by comparison of margin reflex distance1 (MRD1) measurement before and after surgery	6 months

Collaborators and Investigators

• Sponsor: Rabin Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2015
• Primary Completion (Anticipated): July 1, 2020
• Study Completion (Anticipated): July 1, 2020

Study Registration Dates

• First Submitted: July 12, 2015
• First Submitted That Met QC Criteria: July 15, 2015
• First Posted (Estimate): July 17, 2015

Study Record Updates

• Last Update Posted (Actual): April 13, 2018
• Last Update Submitted That Met QC Criteria: April 11, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Eyelid Diseases; Blepharoptosis
• Other Study ID Numbers: Ptosis-01