- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03437434
Scleral Fixation of BunnyLens With GoreTex Suture- Initial Results
Gore-Tex Suture and BunnyLens Scleral Fixation - Historical Retrospective Trial
Study Overview
Detailed Description
4 point scleral fixation of PC- IOL (Posterior Chamber-PC) BunnyLens with Gore-Tex sutures is a surgical technique for implanting IOL in patients with capsular support absence, due to trauma, abnormal anterior chamber, IOL dislocation, or ciliary zonule defect.
The 4 point fixation enables to align the PC- IOL with minimal vertical and horizontal deviation;The Gore-Tex sutures maintain stable scleral fixation with no suture erosion or breakage.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: David Hauser, MD
- Phone Number: 972-526700010
- Email: dehauser@gmail.com
Study Locations
-
-
-
Ashkelon, Israel, 7830604
- Recruiting
- Barzilai University Medical Center
-
Contact:
- Ornit Cohen, M.Med.Sc
- Phone Number: 972 8 6746146
- Email: ornitc@bmc.gov.il
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- patients that underwent secondary cataract surgery or IOL replacement and BunnyLens fixation with Gore-Tex sutures.
Exclusion Criteria:
- Lack of Cooperation, death, severe physical or mental illness, patient's request to withdraw of the clinical trial.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
BunnyLens and Gore-Tex suture
All patients Underwent 4 point PC-IOL scleral fixation with Gore-Tex sutures
|
Ocular Examination
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Distance Visual Acuity
Time Frame: Up to 24 months from surgery.
|
Degree of Visual Acuity is measured in LogMar (-0.3 to1) and by Decimal Value (0.0-2.0)
|
Up to 24 months from surgery.
|
Ocular Refraction
Time Frame: Up to 24 months from surgery.
|
Refraction of the Ocular surfaces, measured in sphere, cylinder and axis.
|
Up to 24 months from surgery.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Slit Lamp Biomicroscopy
Time Frame: Up to 24 months from surgery.
|
Slit lamp examination of the anterior and posterior segments.
|
Up to 24 months from surgery.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: David Hauser, MD, Barzilai University Medical Center
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 114-16-BRZ
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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