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

NCT05062564 | Completed FDA Device

• 1 other identifier: 19220/SPE
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Meibomian Gland Dysfunction; Cataract; Surgery--Complications; Dry Eye; Blepharitis

Outcome Measures

Primary Outcomes (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 Outcomes (6)

• 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)

Study Arms (2)

LipiFlow group

EXPERIMENTAL

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

Device: LipiFlow Thermal pulsation system

Control group

ACTIVE COMPARATOR

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

Procedure: Eyelid warm compresses plus massages

Interventions

LipiFlow Thermal pulsation system DEVICE

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

LipiFlow group

Eyelid warm compresses plus massages PROCEDURE

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

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria Careggi: lead

Study Sites (1)

Eye clinic, Careggi University hospital

Florence, FI, 50134, Italy

Location

Related Publications (2)

• 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.

  PMID: 27345733 RESULT

• Mencucci R, Mercuri S, Cennamo M, Morelli A, Favuzza E. Efficacy of vector thermal pulsation treatment in reducing postcataract surgery dry eye disease in patients affected by meibomian gland dysfunction. J Cataract Refract Surg. 2023 Apr 1;49(4):423-429. doi: 10.1097/j.jcrs.0000000000001124.

  PMID: 36729441 DERIVED

MeSH Terms

Conditions

Meibomian Gland Dysfunction; Cataract; Dry Eye Syndromes; Blepharitis

Interventions

Massage

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases; Lens Diseases; Lacrimal Apparatus Diseases

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Rita Mencucci, MD

  AOU Careggi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 21, 2021
• First Posted: September 30, 2021
• Study Start: September 7, 2021
• Primary Completion: January 17, 2022
• Study Completion: January 17, 2022
• Last Updated: July 21, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)