Risk of Dry Eye Post Different Surgeries for Blepharoptosis Repair
|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
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|