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Clinical Trials/NCT02843594
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.

Registry
clinicaltrials.gov
Start Date
August 2016
End Date
September 2018
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Iantech, Inc
Responsible Party
Sponsor

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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