Risk of Dry Eye Post Different Surgeries for Blepharoptosis Repair
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|ClinicalTrials.gov Identifier: NCT02501187|
Recruitment Status : Unknown
Verified April 2018 by Maya Eiger, Rabin Medical Center.
Recruitment status was: Recruiting
First Posted : July 17, 2015
Last Update Posted : April 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Blepharoptosis||Procedure: Levator advancement Procedure: Müller's muscle-conjunctival resection procedure Procedure: White line advancement||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Comparison Between Three Different Surgeries for Blepharoptosis Repair and Their Impact on Dry Eye Status|
|Actual Study Start Date :||October 8, 2015|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||July 2020|
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.
- Diagnosis of objective or subjective deterioration in dry eye status [ Time Frame: 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
- Ptosis repair procedure success [ Time Frame: 6 months ]Success will be assessed by comparison of margin reflex distance1 (MRD1) measurement before and after surgery
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02501187
|Contact: Maya Eiger, MDfirstname.lastname@example.org|
|Ophthalmology clinics, Rabin Medical Center||Recruiting|
|Petach Tikva, Israel|
|Contact: Maya Eiger, MD +972-3-9376017 email@example.com|
|Principal Investigator: Maya Eiger, MD|
|Principal Investigator:||Maya Eiger, MD||Rabin Medical Center|