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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2018-09-30

Brief Summary

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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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Detailed Description

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Conditions

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Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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LEEP Intervention C1

Cataract surgery with micro-interventional LEEP technology lens fragmentation (non-randomized cohort 1)

Group Type ACTIVE_COMPARATOR

LEEP intervention

Intervention Type PROCEDURE

Low Energy Endosafe Phaco (LEEP) with micro-interventional lens fragmentation

LEEP Intervention C2

Cataract surgery with micro-interventional LEEP technology lens fragmentation (randomized cohort 2)

Group Type ACTIVE_COMPARATOR

LEEP intervention

Intervention Type PROCEDURE

Low Energy Endosafe Phaco (LEEP) with micro-interventional lens fragmentation

Control Phaco C2

Cataract surgery with conventional phaco-assisted lens fragmentation (randomized cohort 2)

Group Type PLACEBO_COMPARATOR

Standard Phaco Control

Intervention Type PROCEDURE

Interventions

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LEEP intervention

Low Energy Endosafe Phaco (LEEP) with micro-interventional lens fragmentation

Intervention Type PROCEDURE

Standard Phaco Control

Intervention Type PROCEDURE

Eligibility Criteria

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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