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Risk of Dry Eye Post Different Surgeries for Blepharoptosis Repair

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Clalit Health Services

Status

Unknown

Conditions

Blepharoptosis

Treatments

Procedure: Müller's muscle-conjunctival resection procedure
Procedure: White line advancement
Procedure: Levator advancement

Study type

Interventional

Funder types

Other

Identifiers

NCT02501187
Ptosis-01

Details and patient eligibility

About

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.

Enrollment

75 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

75 participants in 3 patient groups

Patients operated for ptosis by levator advancement
Experimental group
Description:
patients undergoing surgical repair for aponeurotic ptosis by the procedure- levator advancement.
Treatment:
Procedure: Levator advancement
Patients operated for ptosis by white line advancement
Experimental group
Description:
patients undergoing surgical repair for aponeurotic ptosis by the procedure- white line advancement
Treatment:
Procedure: White line advancement
Patients operated for ptosis by Müller resection
Experimental group
Description:
patients undergoing surgical repair for aponeurotic ptosis by the procedure- Müller's muscle-conjunctival resection.
Treatment:
Procedure: Müller's muscle-conjunctival resection procedure

Trial contacts and locations

1

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Central trial contact

Maya Eiger, MD

Data sourced from clinicaltrials.gov

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