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A Study to Assess the Clinical Outcomes of Surgical Phaco Segmentation Techniques in Patients Undergoing Cataract Surgery

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ClinicalTrials.gov Identifier: NCT02843594
Recruitment Status : Unknown
Verified August 2016 by Iantech, Inc.
Recruitment status was:  Recruiting
First Posted : July 26, 2016
Last Update Posted : August 24, 2016
Sponsor:
Information provided by (Responsible Party):
Iantech, Inc

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cataract Procedure: LEEP intervention Procedure: Standard Phaco Control Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : August 2016
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: LEEP Intervention C1
Cataract surgery with micro-interventional LEEP technology lens fragmentation (non-randomized cohort 1)
 Procedure: LEEP intervention
Low Energy Endosafe Phaco (LEEP) with micro-interventional lens fragmentation
Active Comparator: LEEP Intervention C2
Cataract surgery with micro-interventional LEEP technology lens fragmentation (randomized cohort 2)
 Procedure: LEEP intervention
Low Energy Endosafe Phaco (LEEP) with micro-interventional lens fragmentation
Placebo Comparator: Control Phaco C2
Cataract surgery with conventional phaco-assisted lens fragmentation (randomized cohort 2)
 Procedure: Standard Phaco Control


Outcome Measures
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Primary Outcome Measures :
  1. Cumulative Dispersed Phaco energy [ Time Frame: Intraoperative ]
    Total phaco power and energy used as recorded by the phaco machine


Secondary Outcome Measures :
  1. Endothelial cell loss [ Time Frame: 1 month ]
    Change from baseline endothelial cell density as measured by specular microscopy


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Subjects with a visually significant cataract scheduled to undergo cataract surgery
  3. Subjects > 18 years of age
  4. BCVA at baseline not better than 20/40
  5. Grade 1+ cataracts

Exclusion Criteria:

  1. Subjects not able to complete the informed consent form
  2. Subjects < 18 years of age
  3. Polar cataracts
  4. Zonular instability
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02843594


Contacts
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Contact: Jennifer Gaines +1 (415) 295-4770 admin@iantechmed.com

Locations
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Panama
Clinica de Ojos Panama City Recruiting
Panama, Panama
Contact: Ernesto Calvo, MD    (305) 898-0472    ecalvo86@mac.com   
Sponsors and Collaborators
Iantech, Inc
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Iantech, Inc
ClinicalTrials.gov Identifier: NCT02843594     History of Changes
Other Study ID Numbers: LEEP103
First Posted: July 26, 2016    Key Record Dates
Last Update Posted: August 24, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases