Cataract Clinical Trial
Official title:
The Efficiency of a New Device for Performing Capsulorhexis in Cataract Surgery
Verified date | August 2011 |
Source | Ziv Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Israel: Ministry of Health |
Study type | Interventional |
During cataract operations a capsulorhexis is being performed. This is done in order to
enable the removal of lens material while keeping the capsule intact in order to put inside
the lens capsule an artificial intra ocular lens.
The capsulorhexis must be round and with regular edge and no tears. While performing a
cataract surgery we use phako emulsification machine that sends an ultrasonic wave that
creaks the lens nucleus and at the same time irrigates the anterior chamber of the eye and
sucks the fluid and the lens material of the creaked lens.
The round shape and the regularity of the capsulorhexis are a must in these surgeries since
the lens capsule must stay intact and stable in order to enable the phacoemulsification and
the implant of the artificial lens.
Today capsulorhexis are done with a bent needle or with special forceps; the act of
capsulorhexis is delicate, sometime un predicted and difficult to teach. The learning curve
is relatively long and difficult.
The proposed device enables a capsulorhexis which is round and has regular edges, done
almost automatically and is predicted. The learning curve is short and easy. The
capsulorhexis is done through the original operating wound with no need to widen it.
Status | Enrolling by invitation |
Enrollment | 20 |
Est. completion date | December 2011 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 20 Years to 90 Years |
Eligibility |
Inclusion Criteria: - senile cataract Exclusion Criteria: - dens or mature cataract trauma congenital instability of the lens(phacodonesis,TXF) |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
Israel | Ziv Medical Center | Zefat |
Lead Sponsor | Collaborator |
---|---|
Ziv Hospital |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | capsulorhexis must be round and with regular edge and no tears | As the title of this experiment:"The trying a new device for performing capsulorhexis in cataract surgery".Becuase we are not changing the protocol of Cataract surgery,the outcome measure of this experiment is the efficiency of this device, the safety and the simplicity of the use the device inorder to give a simple and safe solution for capsulorhexis.Therefor the outcome measure will be IOL stability, the shape of capsulorexis and intra ocular post operative inflammation if will occur. The trail is not comparative. | Post operative follow up will be done as usually, one day, one week, 3 weeks and six weeks after operation | Yes |
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