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

Primary Purpose

Meibomian Gland Dysfunction, Cataract, Surgery--Complications

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
LipiFlow Thermal pulsation system
Eyelid warm compresses plus massages
Sponsored by
Azienda Ospedaliero-Universitaria Careggi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Meibomian Gland Dysfunction

Eligibility Criteria

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

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

Sites / Locations

  • Eye clinic, Careggi University hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LipiFlow group

Control group

Arm Description

Single preoperative treatment with the thermal pulsation system LipiFlow within two months before cataract surgery

Eyelid warm compresses plus eyelid massage twice a day for the preoperative month

Outcomes

Primary Outcome Measures

NIBUT (Non-Invasive Break-Up Time)
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

Tear meniscus height
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
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
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
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
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
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)

Full Information

First Posted
September 21, 2021
Last Updated
July 20, 2022
Sponsor
Azienda Ospedaliero-Universitaria Careggi
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1. Study Identification

Unique Protocol Identification Number
NCT05062564
Brief Title
Efficacy of LipiFlow in Patients Affected by Meibomian Gland Dysfunction in Reducing Post-cataract Surgery Dry Eye
Acronym
LIPICAT
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
September 7, 2021 (Actual)
Primary Completion Date
January 17, 2022 (Actual)
Study Completion Date
January 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliero-Universitaria Careggi

4. Oversight

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

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meibomian Gland Dysfunction, Cataract, Surgery--Complications, Dry Eye, Blepharitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LipiFlow group
Arm Type
Experimental
Arm Description
Single preoperative treatment with the thermal pulsation system LipiFlow within two months before cataract surgery
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Eyelid warm compresses plus eyelid massage twice a day for the preoperative month
Intervention Type
Device
Intervention Name(s)
LipiFlow Thermal pulsation system
Intervention Description
Single treatment with LipiFlow thermal pulsation system on the eyelids within two months before surgery
Intervention Type
Procedure
Intervention Name(s)
Eyelid warm compresses plus massages
Intervention Description
Eyelid warm compresses plus massages twice a day for the preoperative month
Primary Outcome Measure Information:
Title
NIBUT (Non-Invasive Break-Up Time)
Description
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)
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)
Secondary Outcome Measure Information:
Title
Tear meniscus height
Description
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)
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)
Title
Schirmer test I
Description
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)
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)
Title
Corneal fluorescein staining
Description
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)
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)
Title
SPEED (Standard Patient Evaluation of Eye Dryness Questionnaire) questionnaire score
Description
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)
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)
Title
Meibomian gland status assessed using confocal microscopy
Description
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)
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)
Title
Eyelid margin assessed using slit lamp examination
Description
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)
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rita Mencucci, MD
Organizational Affiliation
AOU Careggi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eye clinic, Careggi University hospital
City
Florence
State/Province
FI
ZIP/Postal Code
50134
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We have not planned to share individual participant data (IPD)
Citations:
PubMed Identifier
27345733
Citation
Arita R, Minoura I, Morishige N, Shirakawa R, Fukuoka S, Asai K, Goto T, Imanaka T, Nakamura M. Development of Definitive and Reliable Grading Scales for Meibomian Gland Dysfunction. Am J Ophthalmol. 2016 Sep;169:125-137. doi: 10.1016/j.ajo.2016.06.025. Epub 2016 Jun 23.
Results Reference
result

Learn more about this trial

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

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