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Risk of Dry Eye Post Different Surgeries for Blepharoptosis Repair

Primary Purpose

Blepharoptosis

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Levator advancement
Müller's muscle-conjunctival resection procedure
White line advancement
Sponsored by
Rabin Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Blepharoptosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Ophthalmology clinics, Rabin Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Patients operated for ptosis by levator advancement

Patients operated for ptosis by white line advancement

Patients operated for ptosis by Müller resection

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Ptosis repair procedure success
Success will be assessed by comparison of margin reflex distance1 (MRD1) measurement before and after surgery

Full Information

First Posted
July 12, 2015
Last Updated
April 11, 2018
Sponsor
Rabin Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02501187
Brief Title
Risk of Dry Eye Post Different Surgeries for Blepharoptosis Repair
Official Title
Comparison Between Three Different Surgeries for Blepharoptosis Repair and Their Impact on Dry Eye Status
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 8, 2015 (Actual)
Primary Completion Date
July 2020 (Anticipated)
Study Completion Date
July 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rabin Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blepharoptosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients operated for ptosis by levator advancement
Arm Type
Experimental
Arm Description
patients undergoing surgical repair for aponeurotic ptosis by the procedure- levator advancement.
Arm Title
Patients operated for ptosis by white line advancement
Arm Type
Experimental
Arm Description
patients undergoing surgical repair for aponeurotic ptosis by the procedure- white line advancement
Arm Title
Patients operated for ptosis by Müller resection
Arm Type
Experimental
Arm Description
patients undergoing surgical repair for aponeurotic ptosis by the procedure- Müller's muscle-conjunctival resection.
Intervention Type
Procedure
Intervention Name(s)
Levator advancement
Intervention Description
A transcutaneous procedure in which the Levator palpebrae aponeurosis is advanced and attached to the tarsus.
Intervention Type
Procedure
Intervention Name(s)
Müller's muscle-conjunctival resection procedure
Intervention Description
A transconjunctival procedure in which part of the muller muscle and conjunctiva are resected.
Intervention Type
Procedure
Intervention Name(s)
White line advancement
Intervention Description
A transconjunctival procedure in which the Levator palpebrae aponeurosis is advanced and attached to the tarsus.
Primary Outcome Measure Information:
Title
Diagnosis of objective or subjective deterioration in dry eye status
Description
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
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Ptosis repair procedure success
Description
Success will be assessed by comparison of margin reflex distance1 (MRD1) measurement before and after surgery
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maya Eiger, MD
Phone
+972-3-9376107
Email
mayae2@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maya Eiger, MD
Organizational Affiliation
Rabin Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ophthalmology clinics, Rabin Medical Center
City
Petach Tikva
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maya Eiger, MD
Phone
+972-3-9376017
Email
mayae2@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Maya Eiger, MD

12. IPD Sharing Statement

Learn more about this trial

Risk of Dry Eye Post Different Surgeries for Blepharoptosis Repair

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