CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 117 enrolled
Drug / intervention
LipiFlow Thermal Pulsation System +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03708367
NCT03708367N/ACompleted
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A Post-Market Evaluation of LipiFlow Treatment in Cataract Surgery Practice

Johnson & Johnson Surgical Vision, Inc.·interventional·Posted Oct 17, 2018·Updated Apr 27, 2021

In Brief

A clinical study evaluating LipiFlow Thermal Pulsation System for Cataracts and Meibomian Gland Dysfunction (MGD). Completed, enrolled 117 participants across 5 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCataracts, Meibomian Gland Dysfunction (MGD)
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedOct 17, 2018
Enrollment StartOct 16, 2018
Primary CompletionJan 13, 2020
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 7.7 years ago

Interventions

LipiFlow Thermal Pulsation Systemdevice

Treatment at preoperative visit for study group

LipiFlow Thermal Pulsation Systemdevice

Treatment at 3 month visit as the cross-over group