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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02501187
Other study ID # Ptosis-01
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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