Risk of Dry Eye Post Different Surgeries for Blepharoptosis Repair

Study Overview
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Brief Summary
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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.

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

Conditions
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Blepharoptosis

Intervention / Treatment
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* Procedure: Levator advancement
* Procedure: Müller's muscle-conjunctival resection procedure
* Procedure: White line advancement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients operated for ptosis by levator advancement<br>patients undergoing surgical repair for aponeurotic ptosis by the procedure- levator advancement. | Procedure: Levator advancement<br>* A transcutaneous procedure in which the Levator palpebrae aponeurosis is advanced and attached to the tarsus.<br>|
| Experimental: Patients operated for ptosis by white line advancement<br>patients undergoing surgical repair for aponeurotic ptosis by the procedure- white line advancement | Procedure: White line advancement<br>* A transconjunctival procedure in which the Levator palpebrae aponeurosis is advanced and attached to the tarsus.<br>|
| Experimental: Patients operated for ptosis by Müller resection<br>patients undergoing surgical repair for aponeurotic ptosis by the procedure- Müller's muscle-conjunctival resection. | Procedure: Müller's muscle-conjunctival resection procedure<br>* A transconjunctival procedure in which part of the muller muscle and conjunctiva are resected.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ptosis repair procedure success | Success will be assessed by comparison of margin reflex distance1 (MRD1) measurement before and after surgery | 6 months |