CompletedNCT05062564LIPICATUpdated Jul 21, 2022

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

An interventional study of LipiFlow Thermal pulsation system and Eyelid warm compresses plus massages in Meibomian Gland Dysfunction, Cataract and Surgery--Complications, sponsored by Azienda Ospedaliero-Universitaria Careggi. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-21.

Sponsored by Azienda Ospedaliero-Universitaria Careggi · Not applicable, Interventional, and Treatment

From the registry’s dates

Primary completion was Jan 2022, 4 years 9 months ago, and no results have been posted to the registry.

Phase: Not applicable
Study type: Interventional
Enrollment: 46
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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 studied

Meibomian Gland Dysfunction
Cataract
Surgery--Complications
Dry Eye
Blepharitis

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In context

Meibomian Gland Dysfunction

170 studies on the registry are indexed under Meibomian Gland Dysfunction; 20 are open to participants now.

This study's enrollment of 46 is close to the median of 49 across 141 interventional studies indexed under Meibomian Gland Dysfunction.

Browse Meibomian Gland Dysfunction studies →

Lead sponsor

Azienda Ospedaliero-Universitaria Careggi is the lead sponsor of 76 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 46 participants (actual)

Study arms

Experimental
LipiFlow group
Single preoperative treatment with the thermal pulsation system LipiFlow within two months before cataract surgery
Device: LipiFlow Thermal pulsation system
Active comparator
Control group
Eyelid warm compresses plus eyelid massage twice a day for the preoperative month
Procedure: Eyelid warm compresses plus massages

Interventions

DeviceLipiFlow Thermal pulsation system
Single treatment with LipiFlow thermal pulsation system on the eyelids within two months before surgery
ProcedureEyelid warm compresses plus massages
Eyelid warm compresses plus massages twice a day for the preoperative month

What researchers measure

Primary outcomes

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)
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 outcomes

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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)

Study locations

1 site

Eye clinic, Careggi University hospital
Florence, FI 50134, Italy

References and documents

Publications

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. PubMed 27345733 ↗
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. PubMed 36729441 ↗

Individual participant data

Plan to share: No — We have not planned to share individual participant data (IPD)

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2021 to primary completion in Jan 2022, 4 months.

Of 50 non-industry interventional studies with no phase under Meibomian Gland Dysfunction, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 27. This study's 4 months is below that.

Counting every sponsor, half of 73 studies reached it within 10 months; a quarter within 4 and three quarters within 19.

How these figures are worked out, and which studies are left out of them.

Registered: Sep 21, 2021
First posted: Sep 30, 2021
StartActual: Sep 7, 2021
Primary completionActual: Jan 17, 2022
CompletionActual: Jan 17, 2022
Last update: Jul 21, 2022

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Jul 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05062564
Lead sponsor: Azienda Ospedaliero-Universitaria Careggi
Responsible party: Rita Mencucci (Principal Investigator, Azienda Ospedaliero-Universitaria Careggi) — Principal investigator
First posted: Sep 30, 2021
Start date: Sep 7, 2021
Primary completion: Jan 17, 2022
Completion: Jan 17, 2022
Last update: Jul 21, 2022

Study contacts

Rita Mencucci, MD

principal investigator · AOU Careggi

Oversight

FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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