NCT02843594
Unknown
Phase 4
A Study to Assess the Clinical Outcomes of Surgical Phaco Segmentation Techniques in Patients Undergoing Cataract Surgery
Iantech, Inc1 site in 1 country500 target enrollmentAugust 2016
ConditionsCataract
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Cataract
- Sponsor
- Iantech, Inc
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Cumulative Dispersed Phaco energy
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Able to understand study requirements, willing to follow study instructions and willing to return for required study follow-up visits as confirmed by provision of written informed consent.
- •Subjects with a visually significant cataract scheduled to undergo cataract surgery
- •Subjects \> 18 years of age
- •BCVA at baseline not better than 20/40
- •Grade 1+ cataracts
Exclusion Criteria
- •Subjects not able to complete the informed consent form
- •Subjects \< 18 years of age
- •Polar cataracts
- •Zonular instability
Outcomes
Primary Outcomes
Cumulative Dispersed Phaco energy
Time Frame: Intraoperative
Total phaco power and energy used as recorded by the phaco machine
Secondary Outcomes
- Endothelial cell loss(1 month)
Study Sites (1)
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