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

Sponsor
Azienda Ospedaliero-Universitaria Careggi (Other)
Overall Status
Recruiting
CT.gov ID
NCT05062564
Collaborator
(none)
46
Enrollment
1
Location
2
Arms
6.8
Anticipated Duration (Months)
6.7
Patients Per Site Per Month

Study Details

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: LipiFlow Thermal pulsation system
  • Procedure: Eyelid warm compresses plus massages
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
46 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jul 8, 2021
Anticipated Primary Completion Date :
Feb 1, 2022
Anticipated Study Completion Date :
Feb 1, 2022

Arms and Interventions

ArmIntervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. 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)]

    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

  1. 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)]

    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)

  2. 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)]

    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)

  3. 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)]

    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)

  4. 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)]

    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)

  5. 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)]

    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)

  6. 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)]

    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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Eye clinic, Careggi University hospitalFlorenceFIItaly50134

Sponsors and Collaborators

  • Azienda Ospedaliero-Universitaria Careggi

Investigators

  • Principal Investigator: Rita Mencucci, MD, AOU Careggi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rita Mencucci, Principal Investigator, Azienda Ospedaliero-Universitaria Careggi
ClinicalTrials.gov Identifier:
NCT05062564
Other Study ID Numbers:
  • 19220/SPE
First Posted:
Sep 30, 2021
Last Update Posted:
Oct 8, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 8, 2021