A Study to Assess the Clinical Outcomes of Surgical Phaco Segmentation Techniques in Patients Undergoing Cataract Surgery
1 other identifier
interventional
500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2016
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 20, 2016
CompletedFirst Posted
Study publicly available on registry
July 26, 2016
CompletedStudy Start
First participant enrolled
August 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2018
CompletedAugust 24, 2016
August 1, 2016
1.9 years
July 20, 2016
August 22, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Cumulative Dispersed Phaco energy
Total phaco power and energy used as recorded by the phaco machine
Intraoperative
Secondary Outcomes (1)
Endothelial cell loss
1 month
Study Arms (3)
LEEP Intervention C1
ACTIVE COMPARATORCataract surgery with micro-interventional LEEP technology lens fragmentation (non-randomized cohort 1)
LEEP Intervention C2
ACTIVE COMPARATORCataract surgery with micro-interventional LEEP technology lens fragmentation (randomized cohort 2)
Control Phaco C2
PLACEBO COMPARATORCataract surgery with conventional phaco-assisted lens fragmentation (randomized cohort 2)
Interventions
Low Energy Endosafe Phaco (LEEP) with micro-interventional lens fragmentation
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Subjects not able to complete the informed consent form
- Subjects \< 18 years of age
- Polar cataracts
- Zonular instability
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Iantech, Inclead
Study Sites (1)
Clinica de Ojos Panama City
Panama City, Panama
Related Publications (1)
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.
PMID: 29669780DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2016
First Posted
July 26, 2016
Study Start
August 1, 2016
Primary Completion
July 1, 2018
Study Completion
September 1, 2018
Last Updated
August 24, 2016
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will share