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

NCT ID: NCT05062564

Last Updated: 2022-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-07
• Study Completion Date: 2022-01-17

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LipiFlow group

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

Group Type: EXPERIMENTAL

LipiFlow Thermal pulsation system

Intervention Type: DEVICE

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

Control group

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

Group Type: ACTIVE_COMPARATOR

Eyelid warm compresses plus massages

Intervention Type: PROCEDURE

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

Interventions

LipiFlow Thermal pulsation system

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

Intervention Type: DEVICE

Eyelid warm compresses plus massages

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliero-Universitaria Careggi

OTHER

Sponsor Role: lead

Responsible Party

Rita Mencucci

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rita Mencucci, MD

Role: PRINCIPAL_INVESTIGATOR

AOU Careggi

Locations

Eye clinic, Careggi University hospital

Florence, FI, Italy

Countries

Italy

References

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.

Reference Type: RESULT

PMID: 27345733 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36729441 (View on PubMed)

Other Identifiers

19220/SPE

Identifier Type: -

Identifier Source: org_study_id