Risk of Dry Eye Post Different Surgeries for Blepharoptosis Repair

Not Applicable

• Conditions: Blepharoptosis
• Interventions: Procedure: Müller's muscle-conjunctival resection procedure; Procedure: Levator advancement; Procedure: White line advancement

• Registration Number: NCT02501187
• Lead Sponsor: Rabin Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-07-12
• Study First Submitted QC: 2015-07-15
• Study First Posted: 2015-07-17
• Study Start: 2015-10-08
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-11
• Last Update Posted: 2018-04-13
• Primary Completion: 2020-07
• Study Completion: 2020-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients operated for ptosis by Müller resection	Müller's muscle-conjunctival resection procedure	patients undergoing surgical repair for aponeurotic ptosis by the procedure- Müller's muscle-conjunctival resection.
Patients operated for ptosis by levator advancement	Levator advancement	patients undergoing surgical repair for aponeurotic ptosis by the procedure- levator advancement.
Patients operated for ptosis by white line advancement	White line advancement	patients undergoing surgical repair for aponeurotic ptosis by the procedure- white line advancement

Primary Outcome Measures

Name	Time	Method
Diagnosis of objective or subjective deterioration in dry eye status	6 months	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ophthalmology clinics, Rabin Medical Center; 🇮🇱 Petach Tikva, Israel