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Astigmatic Changes Secondary to Eyelid Surgeries

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ClinicalTrials.gov Identifier: NCT01968174
Recruitment Status : Unknown
Verified August 2014 by shay ofir, Meir Medical Center.
Recruitment status was:  Recruiting
First Posted : October 23, 2013
Last Update Posted : August 12, 2014
Sponsor:
Information provided by (Responsible Party):
shay ofir, Meir Medical Center

Brief 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.

Condition or disease
Blepharoptosis

Detailed 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: Astigmatic Corneal Changes Secondary to Eyelid Surgery
Study Start Date : June 2014
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : June 2015

Group/Cohort
eyelid displacement
patients suffering from eyelid disposition due to ptosis, blepharochalasis and are registered for eyelid surgeries will be assigned for the study



Primary Outcome Measures :
  1. astigmatic corneal decrease following eyelid surgery [ Time Frame: 3 months ]
    eyelid change in position will change the effect on corneal astigmatism measured 3 months post surgery


Secondary Outcome Measures :
  1. type of astigmatism [ Time Frame: 3 months ]
    a change from against the rule astigmatism to with the rule astigmatism following eyelid surgery will be evaluated


Other Outcome Measures:
  1. complications [ Time Frame: 3 months ]
    complications following eyelid surgery and their implications on astigmatism



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
patients undergoing eyelid surgery.
Criteria

Inclusion Criteria:

upper lid blepharochalasis

Exclusion Criteria:

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01968174


Contacts
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Contact: ARIK NEMET, DR +972-9747-2154 arik.nemet@gmail.com
Contact: SHAY OFIR, DR +972-9747-2154 shayofir1@gmail.com

Locations
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Israel
Meir Medical Center Recruiting
Kfar Saba, Israel
Contact: ARIK NEMET, DR    +972-9747-2154    arik.nemet@gmail.com   
Contact: SHAY OFIR, DR    +972-9747-2154    shayofir1@gmail.com   
Meir Medical center Recruiting
Kfar Saba, Israel
Contact: arik nemet, Dr.    +972-9747-2154    nemet.arik@gmail.com   
Principal Investigator: ARIK NEMET, Dr         
Sub-Investigator: SHAY OFIR, DR         
Meir Medical Center Suspended
Kfar Saba, Israel
Sponsors and Collaborators
Meir Medical Center
Investigators
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Principal Investigator: Arye - Nemet, MD Meir Medical Center

Additional Information:

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Responsible Party: shay ofir, SHAY OFIR, Meir Medical Center
ClinicalTrials.gov Identifier: NCT01968174     History of Changes
Other Study ID Numbers: oculoplasticmeir001
First Posted: October 23, 2013    Key Record Dates
Last Update Posted: August 12, 2014
Last Verified: August 2014
Keywords provided by shay ofir, Meir Medical Center:
astigmatism
lid surgery
older than 40 years
can sign an acceptance form
uper lid surgery
Additional relevant MeSH terms:
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Blepharoptosis
Eyelid Diseases
Eye Diseases