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A Post-Market Evaluation of LipiFlow Treatment in Cataract Surgery Practice

NCT03708367 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 117

Last updated 2021-04-27

Study results available
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Summary

This is a post-market, prospective, randomized, multi-center, bilateral, open-label, cross-over, comparative clinical study. Study group will undergo preoperative LipiFlow treatment and Control group will not receive preoperative LipiFlow treatment. Three months postoperatively, both groups will be evaluated for clinical outcomes and the Control group will receive LipiFlow treatment as the cross-over group. The Control group will be evaluated at 4 months postoperative for clinical outcomes.

Conditions

  • Cataracts
  • Meibomian Gland Dysfunction (MGD)

Interventions

DEVICE

LipiFlow Thermal Pulsation System

Treatment at preoperative visit for study group

DEVICE

LipiFlow Thermal Pulsation System

Treatment at 3 month visit as the cross-over group

Sponsors & Collaborators

  • Johnson & Johnson Surgical Vision, Inc.

    lead INDUSTRY

Principal Investigators

  • Priya Janakiraman, OD · Johnson & Johnson Surgical Vision, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-16
Primary Completion
2020-01-13
Completion
2020-01-13
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03708367 on ClinicalTrials.gov