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The purpose of this research study is to evaluate the clinical outcomes of different cataract surgical techniques for lens fragmentation in subjects undergoing routine cataract surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LEEP Intervention C1 | Active Comparator | Cataract surgery with micro-interventional LEEP technology lens fragmentation (non-randomized cohort 1) |
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| LEEP Intervention C2 | Active Comparator | Cataract surgery with micro-interventional LEEP technology lens fragmentation (randomized cohort 2) |
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| Control Phaco C2 | Placebo Comparator | Cataract surgery with conventional phaco-assisted lens fragmentation (randomized cohort 2) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LEEP intervention | Procedure | Low Energy Endosafe Phaco (LEEP) with micro-interventional lens fragmentation |
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| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Dispersed Phaco energy | Total phaco power and energy used as recorded by the phaco machine | Intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Endothelial cell loss | Change from baseline endothelial cell density as measured by specular microscopy | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Gaines | Contact | +1 (415) 295-4770 | admin@iantechmed.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica de Ojos Panama City | Recruiting | Panama City | Panama |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29669780 | Derived | Ianchulev T, Chang DF, Koo E, MacDonald S, Calvo E, Tyson FT, Vasquez A, Ahmed IIK. Microinterventional endocapsular nucleus disassembly: novel technique and results of first-in-human randomised controlled study. Br J Ophthalmol. 2019 Feb;103(2):176-180. doi: 10.1136/bjophthalmol-2017-311766. Epub 2018 Apr 18. |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| Standard Phaco Control | Procedure |
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