Risk of Dry Eye Post Different Surgeries for Blepharoptosis Repair

NCT ID: NCT02501187

Last Updated: 2018-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-08

Study Completion Date

2020-07-31

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.

Detailed Description

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Conditions

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Blepharoptosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Patients operated for ptosis by levator advancement

patients undergoing surgical repair for aponeurotic ptosis by the procedure- levator advancement.

Group Type EXPERIMENTAL

Levator advancement

Intervention Type PROCEDURE

A transcutaneous procedure in which the Levator palpebrae aponeurosis is advanced and attached to the tarsus.

Patients operated for ptosis by white line advancement

patients undergoing surgical repair for aponeurotic ptosis by the procedure- white line advancement

Group Type EXPERIMENTAL

White line advancement

Intervention Type PROCEDURE

A transconjunctival procedure in which the Levator palpebrae aponeurosis is advanced and attached to the tarsus.

Patients operated for ptosis by Müller resection

patients undergoing surgical repair for aponeurotic ptosis by the procedure- Müller's muscle-conjunctival resection.

Group Type EXPERIMENTAL

Müller's muscle-conjunctival resection procedure

Intervention Type PROCEDURE

A transconjunctival procedure in which part of the muller muscle and conjunctiva are resected.

Interventions

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Levator advancement

A transcutaneous procedure in which the Levator palpebrae aponeurosis is advanced and attached to the tarsus.

Intervention Type PROCEDURE

Müller's muscle-conjunctival resection procedure

A transconjunctival procedure in which part of the muller muscle and conjunctiva are resected.

Intervention Type PROCEDURE

White line advancement

A transconjunctival procedure in which the Levator palpebrae aponeurosis is advanced and attached to the tarsus.

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rabin Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Maya Eiger

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maya Eiger, MD

Role: PRINCIPAL_INVESTIGATOR

Rabin Medical Center

Locations

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Ophthalmology clinics, Rabin Medical Center

Petah Tikva, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Maya Eiger, MD

Role: CONTACT

+972-3-9376107

Facility Contacts

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Maya Eiger, MD

Role: primary

+972-3-9376017

Other Identifiers

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Ptosis-01

Identifier Type: -

Identifier Source: org_study_id

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