Efficacy of LipiFlow in Patients Affected by Meibomian Gland Dysfunction in Reducing Post-cataract Surgery Dry Eye (LIPICAT)

July 20, 2022 updated by: Rita Mencucci, Azienda Ospedaliero-Universitaria Careggi

Evaluation of the Efficacy of LipiFlow Thermal Pulsation Treatment Performed Before Cataract Surgery in Patients Affected by Meibomian Gland Dysfunction in Reducing Postoperative Dry Eye Disease

Dry Eye Disease (DED) is a disease of the ocular surface which may be secondary to a variety of causes, including cataract surgery. DED is characterized by loss of tear film stability and dry eye symptoms, and its pathogenesis is related to corneal nerve injury, decreased goblet cells, inflammation of the ocular surface, and dysfunction of the meibomian glands (MGD). MGD is the main cause of evaporative DED and can cause irregularity of the ocular surface, affecting the accuracy of the biometric calculation. In addition, it is a risk factor for DED exacerbation after cataract surgery, that may occur in about 40% of cases. Current therapies for DED include artificial tears, warm compresses, manual squeezing of the glands, eyelid hygiene, omega-3 fatty acids, topical cyclosporine, serum tears, topical azithromycin, oral doxycycline. The above therapies in some cases can provide only transient relief, affecting the outcome of cataract surgery and the quality of life of patients. Therefore, stabilization of the ocular surface before cataract surgery is important to achieve better post-operative comfort and a better refractive result. The introduction of LipiFlow thermal pulsation treatment (LTP) represents a controlled method of squeezing the obstructed Meibomian glands by applying heat to the upper and lower eyelids and simultaneously applying pulsatile pressure to the eyelid skin surfaces. The aim of our study will be to evaluate the effect of preoperative LipiFlow therapy in patients with age-related cataracts and mild to moderate MGD in reducing postoperative DED.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
46

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • FI
      • Florence, FI, Italy, 50134
        • Eye clinic, Careggi University hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men or women ≥18 years old
  • Patients affected by age-related cataract <3 according to the Lens Opacities Classification System III scale (LOCS III)
  • Meibomian gland dysfunction (MGD) diagnosed using slit lamp examination, following the criteria reported in the paper Arita R. et al, Am J Ophthalmol. 2016 Sep;169:125-137.
  • Fluorescein tear BUT <7 seconds

Exclusion Criteria:

  • Subjects with documented history and / or clinical signs of concomitant presence of an eye infection caused by viruses such as herpes simplex virus (HSV) or fungi in the previous 3 months.
  • Patients with anterior blepharitis or Demodex
  • Meibomian gland atrophy score greater than 2/3
  • Subject treated with drugs that can have effects on MGD prior to inclusion in the study
  • Active ocular inflammation or history of chronic eye inflammation recurrent in the previous 3 months (e.g. retinitis, macular inflammation, choroiditis, uveitis, iritis, scleritis, episcleritis, keratitis)
  • Eyelid abnormalities affecting eyelid function (entropion, ectropion, neoplasia, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis)
  • Abnormalities of the ocular surface that compromise the integrity of the cornea (e.g.

previous chemical burn, recurrent corneal erosion, corneal epithelial defect, corneal dystrophy)

  • Subjects who underwent eye surgery in the previous 3 months, including intraocular, oculo-plastic, corneal or refractive surgery
  • Patients suffering from diabetes mellitus, rheumatism, immune diseases and other serious systemic diseases
  • Pregnant or lactating women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: LipiFlow group
Single preoperative treatment with the thermal pulsation system LipiFlow within two months before cataract surgery
Device: LipiFlow Thermal pulsation system
Single treatment with LipiFlow thermal pulsation system on the eyelids within two months before surgery
ACTIVE_COMPARATOR: Control group
Eyelid warm compresses plus eyelid massage twice a day for the preoperative month
Procedure: Eyelid warm compresses plus massages
Eyelid warm compresses plus massages twice a day for the preoperative month

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
NIBUT (Non-Invasive Break-Up Time)
Time Frame: The difference between the change in NIBUT of LipiFlow group and control group between Visit 0 (screening/baseline) and Visit 2 (one month after surgery)
The difference between the change in NIBUT of LipiFlow group and control group between Visit 0 (screening/baseline) and Visit 2 (one month after surgery)
The difference between the change in NIBUT of LipiFlow group and control group between Visit 0 (screening/baseline) and Visit 2 (one month after surgery)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Tear meniscus height
Time Frame: The difference between the change in tear meniscus height of LipiFlow group and control group between Visit 0 (screening/baseline) and Visit 2 (one month after surgery)
The difference between the change in tear meniscus height of LipiFlow group and control group between Visit 0 (screening/baseline) and Visit 2 (one month after surgery)
The difference between the change in tear meniscus height of LipiFlow group and control group between Visit 0 (screening/baseline) and Visit 2 (one month after surgery)
Schirmer test I
Time Frame: The difference between the change in Schirmer test I of LipiFlow group and control group between Visit 0 (screening/baseline) and Visit 2 (one month after surgery)
The difference between the change in Schirmer test I of LipiFlow group and control group between Visit 0 (screening/baseline) and Visit 2 (one month after surgery)
The difference between the change in Schirmer test I of LipiFlow group and control group between Visit 0 (screening/baseline) and Visit 2 (one month after surgery)
Corneal fluorescein staining
Time Frame: The difference between the change in corneal fluorescein staining of LipiFlow group and control group between Visit 0 (screening/baseline) and Visit 2 (one month after surgery)
The difference between the change in corneal fluorescein staining of LipiFlow group and control group between Visit 0 (screening/baseline) and Visit 2 (one month after surgery)
The difference between the change in corneal fluorescein staining of LipiFlow group and control group between Visit 0 (screening/baseline) and Visit 2 (one month after surgery)
SPEED (Standard Patient Evaluation of Eye Dryness Questionnaire) questionnaire score
Time Frame: The difference between the change in SPEED questionnaire score of LipiFlow group and control group between Visit 0 (screening/baseline) and Visit 2 (one month after surgery)
The difference between the change in SPEED questionnaire score of LipiFlow group and control group between Visit 0 (screening/baseline) and Visit 2 (one month after surgery)
The difference between the change in SPEED questionnaire score of LipiFlow group and control group between Visit 0 (screening/baseline) and Visit 2 (one month after surgery)
Meibomian gland status assessed using confocal microscopy
Time Frame: The difference between the change in Meibomian gland status of LipiFlow group and control group between Visit 0 (screening/baseline) and Visit 2 (one month after surgery)
The difference between the change in Meibomian gland status of LipiFlow group and control group between Visit 0 (screening/baseline) and Visit 2 (one month after surgery)
The difference between the change in Meibomian gland status of LipiFlow group and control group between Visit 0 (screening/baseline) and Visit 2 (one month after surgery)
Eyelid margin assessed using slit lamp examination
Time Frame: The difference between the change in eyelid margins of LipiFlow group and control group between Visit 0 (screening/baseline) and Visit 2 (one month after surgery)
The difference between the change in eyelid margins of LipiFlow group and control group between Visit 0 (screening/baseline) and Visit 2 (one month after surgery)
The difference between the change in eyelid margins of LipiFlow group and control group between Visit 0 (screening/baseline) and Visit 2 (one month after surgery)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Azienda Ospedaliero-Universitaria Careggi

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rita Mencucci, MD, Aou Careggi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 7, 2021

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 17, 2022

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 17, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 21, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 30, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 21, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 19220/SPE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We have not planned to share individual participant data (IPD)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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