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

Primary Purpose

Cataract

Status

Unknown status

Phase

Phase 4

Locations

Panama

Study Type

Interventional

Intervention

LEEP intervention

Standard Phaco Control

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.
Subjects with a visually significant cataract scheduled to undergo cataract surgery
Subjects > 18 years of age
BCVA at baseline not better than 20/40
Grade 1+ cataracts

Exclusion Criteria:

Subjects not able to complete the informed consent form
Subjects < 18 years of age
Polar cataracts
Zonular instability

Sites / Locations

Clinica de Ojos Panama CityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

LEEP Intervention C1

LEEP Intervention C2

Control Phaco C2

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Cumulative Dispersed Phaco energy

Total phaco power and energy used as recorded by the phaco machine

Secondary Outcome Measures

Endothelial cell loss

Change from baseline endothelial cell density as measured by specular microscopy

Full Information

NCT ID

NCT02843594

First Posted

July 20, 2016

Last Updated

August 22, 2016

Sponsor

Iantech, Inc

1. Study Identification

Unique Protocol Identification Number

NCT02843594

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Unknown status

Study Start Date

August 2016 (undefined)

Primary Completion Date

July 2018 (Anticipated)

Study Completion Date

September 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Iantech, Inc

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cataract

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

LEEP Intervention C1

Arm Type

Active Comparator

Arm Description

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

Arm Title

LEEP Intervention C2

Arm Type

Active Comparator

Arm Description

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

Arm Title

Control Phaco C2

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

LEEP intervention

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Standard Phaco Control

Primary Outcome Measure Information:

Title

Cumulative Dispersed Phaco energy

Description

Total phaco power and energy used as recorded by the phaco machine

Time Frame

Intraoperative

Secondary Outcome Measure Information:

Title

Endothelial cell loss

Description

Change from baseline endothelial cell density as measured by specular microscopy

Time Frame

1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Subjects with a visually significant cataract scheduled to undergo cataract surgery Subjects > 18 years of age BCVA at baseline not better than 20/40 Grade 1+ cataracts Exclusion Criteria: Subjects not able to complete the informed consent form Subjects < 18 years of age Polar cataracts Zonular instability

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jennifer Gaines

Phone

+1 (415) 295-4770

admin@iantechmed.com

Facility Information:

Facility Name

Clinica de Ojos Panama City

City

Panama

Country

Panama

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ernesto Calvo, MD

Phone

(305) 898-0472

ecalvo86@mac.com

12. IPD Sharing Statement

Plan to Share IPD

Yes

Citations:

PubMed Identifier

29669780

Citation

Ianchulev T, Chang DF, Koo E, MacDonald S, Calvo E, Tyson FT, Vasquez A, Ahmed IIK. Microinterventional endocapsular nucleus disassembly: novel technique and results of first-in-human randomised controlled study. Br J Ophthalmol. 2019 Feb;103(2):176-180. doi: 10.1136/bjophthalmol-2017-311766. Epub 2018 Apr 18.

Results Reference

derived

Learn more about this trial

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

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