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NCT Number: NCT05062564

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

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.

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Key information

Conditions

Meibomian Gland Dysfunction Blepharitis Cataract Dry Eye Dry Eye Syndromes Eye Diseases Eyelid Diseases Lacrimal Apparatus Diseases Lens Diseases Surgery--Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eye clinic, Careggi University hospital

Florence, FI, 50134, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lipiflow Thermal Pulsation System

Device

Single treatment with LipiFlow thermal pulsation system on the eyelids within two months before surgery

Eyelid warm compresses plus massages

Procedure

Eyelid warm compresses plus massages twice a day for the preoperative month

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero-Universitaria Careggi

Other

Registry information

Official study 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

Acronym: LIPICAT

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 30, 2021
Registry last updated
Jul 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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