Risk of Dry Eye Post Different Surgeries for Blepharoptosis Repair

Blepharoptosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02501187
• Other study ID #: Ptosis-01
• Status: Recruiting
• Phase: N/A
• First received: July 12, 2015
• Last updated: April 11, 2018
• Start date: October 8, 2015
• Est. completion date: July 2020

Study information

• Verified date: April 2018
• Source: Rabin Medical Center
• Contact: Maya Eiger, MD
• Phone: +972-3-9376107
• Email: mayae2[@]clalit.org.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: July 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blepharoptosis

Intervention

Procedure:
• Levator advancement
A transcutaneous procedure in which the Levator palpebrae aponeurosis is advanced and attached to the tarsus.
• Müller's muscle-conjunctival resection procedure
A transconjunctival procedure in which part of the muller muscle and conjunctiva are resected.
• White line advancement
A transconjunctival procedure in which the Levator palpebrae aponeurosis is advanced and attached to the tarsus.

Locations

Country	Name	City	State
Israel	Ophthalmology clinics, Rabin Medical Center	Petach Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Ptosis repair procedure success	Success will be assessed by comparison of margin reflex distance1 (MRD1) measurement before and after surgery	6 months