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

August 22, 2016 updated by: Iantech, Inc
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Panama
      • Panama, Panama
        • Recruiting
        • Clinica de Ojos Panama City
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative Dispersed Phaco energy
Time Frame: Intraoperative
Total phaco power and energy used as recorded by the phaco machine
Intraoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endothelial cell loss
Time Frame: 1 month
Change from baseline endothelial cell density as measured by specular microscopy
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Iantech, Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (ANTICIPATED)

July 1, 2018

Study Completion (ANTICIPATED)

September 1, 2018

Study Registration Dates

First Submitted

July 20, 2016

First Submitted That Met QC Criteria

July 21, 2016

First Posted (ESTIMATE)

July 26, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

August 24, 2016

Last Update Submitted That Met QC Criteria

August 22, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LEEP103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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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