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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01968174
Other study ID # oculoplasticmeir001
Secondary ID
Status Recruiting
Phase N/A
First received October 19, 2013
Last updated August 11, 2014
Start date June 2014
Est. completion date June 2015

Study information

Verified date August 2014
Source Meir Medical Center
Contact ARIK NEMET, DR
Phone +972-9747-2154
Email arik.nemet@gmail.com
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational [Patient Registry]

Clinical Trial Summary

Eyelid surgeries change the lid position over the cornea. Previous surgeries evaluated astigmatic corneal changes in children undergoing ptosis repair. Only several studies evaluated astigmatic changes following eyelid surgeries in elderly patients. The investigators aim is to estimate this change, implications on corneal astigmatism may have great effect to future cataract surgeries for this group of patients.


Description:

Patients registered for a lid surgery due to blepharoptosis or ptosis will undergo a topographic examination prior to and 3 months post operative in addition to their regular pre and post operative examination astigmatic shift will be mathematically measured.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date June 2015
Est. primary completion date June 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 40 Years to 80 Years
Eligibility Inclusion Criteria:

upper lid blepharochalasis

Exclusion Criteria:

prior eyelid trauma mental retardation or other causes preventing from signing an agreement form

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Israel Meir Medical Center Kfar Saba
Israel Meir Medical center Kfar Saba
Israel Meir Medical Center Kfar Saba

Sponsors (1)

Lead Sponsor Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Other complications complications following eyelid surgery and their implications on astigmatism 3 months No
Primary astigmatic corneal decrease following eyelid surgery eyelid change in position will change the effect on corneal astigmatism measured 3 months post surgery 3 months No
Secondary type of astigmatism a change from against the rule astigmatism to with the rule astigmatism following eyelid surgery will be evaluated 3 months No
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