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

Cataract Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02843594
• Other study ID #: LEEP103
• Status: Recruiting
• Phase: Phase 4
• First received: July 20, 2016
• Last updated: August 22, 2016
• Start date: August 2016
• Est. completion date: September 2018

Study information

• Verified date: August 2016
• Source: Iantech, Inc
• Contact: Jennifer Gaines
• Phone: +1 (415) 295-4770
• Email: admin[@]iantechmed.com
• Is FDA regulated: No
• Health authority: Panama: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: September 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract

Intervention

Procedure:
• LEEP intervention
Low Energy Endosafe Phaco (LEEP) with micro-interventional lens fragmentation
• Standard Phaco Control

Locations

Country	Name	City	State
Panama	Clinica de Ojos Panama City	Panama

Sponsors (1)

Lead Sponsor	Collaborator
Iantech, Inc

Country where clinical trial is conducted

Panama, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative Dispersed Phaco energy	Total phaco power and energy used as recorded by the phaco machine	Intraoperative	No
Secondary	Endothelial cell loss	Change from baseline endothelial cell density as measured by specular microscopy	1 month	Yes