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

Iantech

Status and phase: Unknown; Phase 4

Conditions: Cataract

Treatments: Procedure: LEEP intervention; Procedure: Standard Phaco Control

Study type: Interventional

Funder types: Industry

Identifiers

NCT02843594

LEEP103

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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500 participants in 3 patient groups, including a placebo group

LEEP Intervention C1

Active Comparator group

Description:

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

Treatment:

Procedure: LEEP intervention

LEEP Intervention C2

Active Comparator group

Description:

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

Treatment:

Procedure: LEEP intervention

Control Phaco C2

Placebo Comparator group

Description:

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

Treatment:

Procedure: Standard Phaco Control