- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01968174
Astigmatic Changes Secondary to Eyelid Surgeries
August 11, 2014 updated by: shay ofir, Meir Medical Center
Astigmatic Corneal Changes Secondary to Eyelid Surgery
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.
Study Overview
Status
Unknown
Conditions
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.
Study Type
Observational
Enrollment (Anticipated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: ARIK NEMET, DR
- Phone Number: +972-9747-2154
- Email: arik.nemet@gmail.com
Study Contact Backup
- Name: SHAY OFIR, DR
- Phone Number: +972-9747-2154
- Email: shayofir1@gmail.com
Study Locations
-
-
-
Kfar Saba, Israel
- Recruiting
- Meir Medical Center
-
Contact:
- arik nemet, Dr.
- Phone Number: +972-9747-2154
- Email: nemet.arik@gmail.com
-
Principal Investigator:
- ARIK NEMET, Dr
-
Sub-Investigator:
- SHAY OFIR, DR
-
Kfar Saba, Israel
- Suspended
- Meir Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients undergoing eyelid surgery.
Description
Inclusion Criteria:
upper lid blepharochalasis
Exclusion Criteria:
prior eyelid trauma mental retardation or other causes preventing from signing an agreement form
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
3 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
complications
Time Frame: 3 months
|
complications following eyelid surgery and their implications on astigmatism
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Arye - Nemet, MD, Meir Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2014
Primary Completion (Anticipated)
June 1, 2015
Study Completion (Anticipated)
June 1, 2015
Study Registration Dates
First Submitted
October 19, 2013
First Submitted That Met QC Criteria
October 22, 2013
First Posted (Estimate)
October 23, 2013
Study Record Updates
Last Update Posted (Estimate)
August 12, 2014
Last Update Submitted That Met QC Criteria
August 11, 2014
Last Verified
August 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- oculoplasticmeir001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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