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

Phase 4

• Conditions: Cataract
• Interventions: Procedure: LEEP intervention; Procedure: Standard Phaco Control

• Registration Number: NCT02843594
• Lead Sponsor: Iantech, Inc

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-07-20
• Study First Submitted QC: 2016-07-21
• Study First Posted: 2016-07-26
• Status Verified: 2016-08
• Study Start: 2016-08
• Last Update Submitted: 2016-08-22
• Last Update Posted: 2016-08-24
• Primary Completion: 2018-07
• Study Completion: 2018-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LEEP Intervention C2	LEEP intervention	Cataract surgery with micro-interventional LEEP technology lens fragmentation (randomized cohort 2)
LEEP Intervention C1	LEEP intervention	Cataract surgery with micro-interventional LEEP technology lens fragmentation (non-randomized cohort 1)
Control Phaco C2	Standard Phaco Control	Cataract surgery with conventional phaco-assisted lens fragmentation (randomized cohort 2)

Primary Outcome Measures

Name	Time	Method
Cumulative Dispersed Phaco energy	Intraoperative	Total phaco power and energy used as recorded by the phaco machine

Secondary Outcome Measures

Name	Time	Method
Endothelial cell loss	1 month	Change from baseline endothelial cell density as measured by specular microscopy

Trial Locations

Locations (1)

Clinica de Ojos Panama City; 🇵🇦 Panama, Panama