. 2024 Jun 15;13(8):2083–2123. doi: 10.1007/s40123-024-00976-1

Table 6.

Summary of studies evaluating LipiFlow in patients undergoing cataract surgery or with treated glaucoma

Author/design/country	Patients (eyes)/age, mean (SD)	Last FU after LF Tx	Study arms	MG function Mean (SD)	Patient-reported symptoms Mean (SD)	TBUT Mean (SD)	Staining	Overall conclusion and safety
Cataract
Schlatter 2023 [63] Prospective, randomized, controlled, investigator-masked	N = 31 patients with MGD and cataract (62 eyes), 44 (16) years; LF: N = 29 eyes; CL: N = 29 eyes	3 months preop	Single 12-min LF Tx before cataract surgery CL: untreated	MGSS LF: 9.5 (5.2) CL: 9.9 (4.9)	MGSS LF: 14.4 (9.1)* CL: 13.6 (10.5)	NR	NR	TBUT LF: 5.6 (2.7) CL: 4.9 (2.1)	TBUT LF: 8.8 (4.4)* CL: 7.8 (4.4)*	NR	NR	Tear film parameters improved in LF eyes, but effect on spherical IOL selection was negligible AEs N = 1 (stye unrelated to LF)
Mencucci 2023 [66] Prospective, unmasked, randomized controlled Italy	N = 46 patients with cataract and mild/moderate MGD (46 eyes), LF: N = 23 patients (23 eyes), 73 (8) years CL: N = 23 patients (23 eyes), 75 (8) years	1 month (pre-cataract surgery) 2 months (= 1 month post-cataract surgery)	Single 12-min LF Tx CL: warm compress, massage BID for 1 month	MGYLS LF: 7.3 (0.8) CL: 7.7 (0.6) MGSS LF: 0.65 (0.77) CL: 0.33 (0.56)	MGYLS 1 month (preop): LF: 7.8 (0.51)* CL: 7.8 (0.4) 2 months (postop): LF: 7.9 (0.3)† CL: 7.5 (0.7) MGSS 1 month (preop): LF: 0.21 (0.52) CL: 0.21 (0.41) 2 months (postop): LF: 0.13 (0.34)*† CL: 0.54 (0.60)	SPEED LF: 6.1 (2.8) CL: 5.8 (1.5)	SPEED 1 month (preop): LF: 3.9 (2.2)† CL: 5.1 (1.5) 2 months (postop): LF: 4.0 (1.8)† CL: 6.0 (1.2)	NIKBUT LF: 5.2 (1.3) CL: 5.7 (1.2)	NIKBUT 1 month (preop): LF: 6.2 (1.7)* CL: 6.0 (1.2) 2 months (postop): LF: 6.3 (1.9)*† CL: 5.1 (1.5)	Corneal LF: 0.26 (0.44) CL: 0.13 (0.33)	Corneal 1 month (preop): LF: 0.13 (0.33) CL: 0.13 (0.33) 2 months (postop): LF: 0.13 (0.34) CL: 0.13 (0.33)	Preop LF Tx prevented postcataract surgery DED in patients with mild-to-moderate MGD. LF-treated patients had a better ocular surface status than CL AEs None No pain or discomfort
Matossian 2023 [67] Prospective, randomized, open-label, crossover, multicenter USA	N = 121 patients with mild-to-moderate MGD and cataract; LF: N = 117 eyes, 65 (8) years; CL: N = 115 eyes, 65 (8) years	3 months (3 months post-cataract surgery) CO: 1 month (4 months post-cataract surgery)	Single 12-min LF Tx CL: untreated	NR	MGSS: Change from BL to 3 months (postop): LF: 7.3 (9.3)† CL: 4.7 (10.1) MGYLS Change from BL to 1 month postop: LF: 1.6 (3.1) CL: 1.1 (3.3) CO MGSS: Change from 3 to 4 months postop: LF: 4.1 (11.0)†	NR	SPEED: Change from BL to 3 months: LF: -2.1 (5.3) CL:-1.5 (5.6) CO SPEED: Change from 3 to 4 months postop: LF: − 1.2 (5.6)	NR	TBUT Change from BL to 1 month postop: LF: 0.69 (4.6) CL: 0.06 (3.7)	NR	Corneal Change from BL to 1 month postop: LF: − 0.57 (2.3)† CL: 0.20 (3.2) Conjunct Change from BL to 1 month postop: LF: − 1.2 (3.8)† CL: 0.45 (4.0)	Presurgical LF Tx of patients implanted with range-of-vision IOLs improved MG function and postop ocular surface health. LF Tx reduced postop halos and improved VA AEs None related to LF, all related to cataract surgery
Park 2021 [69] Prospective, randomized controlled study Korea	N = 124 patients with cataract (MGD was not a requirement) (124 eyes); LF: N = 60 patients (60 eyes), 64 (9) years CL: N = 48 patients (48 eyes), 65 (12) years	3 months postop	Single 12-min LF Tx CL: untreated	MGSS LF: 1.0 (0.9) CL: 0.9 (0.8) MGYLS LF: 6.0 (2.1) CL:6.6 (2.1)	MGSS LF: 0.9 (0.9)† CL: 1.7 (0.8) MGYLS LF: 7.1 (1.7)† CL: 5.6 (2.6)	OSDI LF: 37.9 (20.2) CL: 34.3 (20.1)	OSDI LF: 22.3 (16.5)*† CL: 29.8 (20.8)	TBUT LF: 3.5 (1.5) CL: 3.7 (1.5)	TBUT LF: 4.4 (1.8)*† CL: 3.6 (1.6)	Corneal LF:0.77 (0.90) CL: 0.68 (0.92)	Corneal LF: 0.46 (0.56)* CL: 0.62 (0.56)	LF Tx conducted prior to cataract surgery may be safe and effective for relieving MGD and dry eye induced by surgery AEs None. No pain at insertion, treatment, or removal
Zhao Y 2021 [68] Prospective, examiner-masked controlled, contralateral eye China	N = 32 patients with MGD and cataract (64 eyes); N = 16 patients undergoing cataract surgery, LF: N = 16 eyes, CL: N = 16 eyes, 62 (10) years; N = 16 patients no surgery (control), LF: N = 16 eyes, CL: N = 16 eyes, 62 (2) years In both groups LF in 1 eye and untreated contralateral eye	3 months	Single 12-min LF Tx CL: untreated	MGYLS LF/surgery: 2.1 (1.8) CL/surgery: 1.9 (1.8) LF/non-surgery: 1.8 (1.8) CL/non-surgery: 2.6 (2.5)	MGYLS median change from BL: LF/surgery: 4.0* CL/surgery: − 2.0 LF/non-surgery: 3.0* CL/non-surgery: 0.0 (P < 0.05 vs. CL/surgery)	SPEED xx¹	SPEED xx¹	TBUT LF/surgery: 5.0 (2.3) CL/surgery: 4.9 (2.6) LF/non-surgery: 2.5 (0.6) CL/non-surgery: 2.8 (1.1)	TBUT median change from BL: LF/surgery: − 2.5 CL/surgery: − 2.0 LF/non-surgery: 1.0 (P < 0.05 vs. LF/surgery) CL/non-surgery: 0.0 (P < 0.05 vs. CL/surgery)	Corneal LF/surgery: 3.1 (0.4) CL/surgery: 3.2 (0.5) LF/non-surgery: 2.0 (0.5) CL/non-surgery: 1.9 (0.8)	Corneal xx¹	LF Tx before cataract surgery is effective in diminishing the blockage of MG and preventing a decline of TBUT after cataract surgery. Safety NR
Szabelska 2023 [64] Open-label case series Poland	N = 6 patients with MGD and cataract (11 eyes), 67 years	6 weeks	Single 12-min LF Tx 6 weeks pre-cataract surgery	NR	NR	OSDI LF: 31.1	OSDI LF: 22.7	TBUT LF: 9.1	TBUT LF: 13.9	NR	NR	Stabilization of visual system parameters after LF improved accuracy of IOL power recommendation. Safety NR
Matossian 2020 [65] Single-center, pilot, retrospective USA	N = 23 patients with MGD and cataract (25 eyes), 73 (8) years	6 weeks	Single 12-min LF Tx 6 weeks pre- cataract surgery	NR	NR	NR	NR	NR	NR	NR	NR	LF Tx resulted in less residual refractive astigmatism compared with pre-LF keratometry readings, which altered astigmatism management/ IOL selection. Safety NR
Glaucoma
Kasetsuwan 2020 [70] Prospective, randomized, observer-blind Thailand	N = 60 patients with well-controlled glaucoma and MGD; LF: N = 26 patients (26 eyes), 67 (11) years; CL: N = 22 patients (22 eyes), 70 (8) years	6 months	Single 12-min LF Tx plus lid hygiene CL: lid hygiene: warm compress, massage, baby shampoo, BID for 6 months	MGSS LF: 21.5 (5.8) CL: 22.5 (5.9)	MGSS change from BL: LF: 4.7* CL: 3.0*	OSDI LF: 23.7 (11.8) CL: 26.8 (18.2)	OSDI change from BL: LF: − 7.8* CL: -11.8*	TBUT LF: 5.4 (3.7) CL: 6.0 (5.4)	TBUT Change from BL: LF: − 0.30 CL:-0.58	Corneal LF: 1.3 (0.8) CL: 1.0 (0.6)	Corneal Change from BL: LF: 0 CL: 0	Adding LF Tx to lid hygiene significantly improved MG function and symptoms at 6 months AEs LF: N = 7 patients (N = 1 difficulty inserting the device, N = 5 mild discomfort immediately after Tx, N = 1 mild conjunctival injection CL: N = NR discomfort during massage. No IOP elevation or uncontrolled IOP that required additional antiglaucoma Tx

Author/design/country

Patients (eyes)/age, mean (SD)

Last FU after LF Tx

Study arms

MG function
Mean (SD)

Patient-reported symptoms
Mean (SD)

TBUT
Mean (SD)

Staining

Overall conclusion and safety

Pre

Post

Pre

Post

Pre

Post

Pre

Post

Cataract

Schlatter 2023 [63]

Prospective, randomized,

controlled, investigator-masked

N = 31 patients with MGD and cataract (62 eyes), 44 (16) years;

LF: N = 29 eyes;

CL: N = 29 eyes

3 months preop

Single 12-min LF Tx before cataract surgery

CL: untreated

MGSS

LF: 9.5

(5.2)

CL: 9.9 (4.9)

MGSS

LF: 14.4

(9.1)*

CL: 13.6

(10.5)

TBUT

LF: 5.6

(2.7)

CL: 4.9 (2.1)

TBUT

LF: 8.8

(4.4)*

CL: 7.8

(4.4)*

Tear film parameters improved in LF eyes, but effect on spherical

IOL selection was negligible

AEs

N = 1 (stye unrelated to LF)

Mencucci 2023 [66]

Prospective, unmasked, randomized controlled

Italy

N = 46 patients with cataract and mild/moderate MGD (46 eyes), LF: N = 23 patients (23 eyes), 73 (8) years

CL: N = 23 patients (23 eyes), 75 (8) years

1 month (pre-cataract surgery)

2 months (= 1 month post-cataract surgery)

Single 12-min LF Tx

CL: warm compress, massage BID for 1 month

MGYLS

LF: 7.3 (0.8)

CL: 7.7 (0.6)

MGSS

LF: 0.65 (0.77)

CL: 0.33 (0.56)

MGYLS

1 month (preop):

LF: 7.8 (0.51)*

CL: 7.8 (0.4)

2 months (postop):

LF: 7.9 (0.3)*†

CL: 7.5 (0.7)

MGSS

1 month (preop):

LF: 0.21 (0.52)*

CL: 0.21 (0.41)

2 months (postop):

LF: 0.13 (0.34)*†

CL: 0.54 (0.60)

SPEED

LF: 6.1 (2.8)

CL: 5.8 (1.5)

SPEED

1 month (preop):

LF: 3.9 (2.2)*†

CL: 5.1 (1.5)

2 months (postop): LF: 4.0 (1.8)*†

CL: 6.0 (1.2)

NIKBUT

LF: 5.2 (1.3)

CL: 5.7 (1.2)

NIKBUT

1 month (preop):

LF: 6.2 (1.7)*

CL: 6.0 (1.2)

2 months (postop):

LF: 6.3 (1.9)*†

CL: 5.1 (1.5)

Corneal

LF: 0.26 (0.44)

CL: 0.13 (0.33)

Corneal

1 month (preop):

LF: 0.13 (0.33)

CL: 0.13 (0.33)

2 months (postop):

LF: 0.13 (0.34)

CL: 0.13 (0.33)

Preop LF Tx prevented postcataract surgery DED in patients with mild-to-moderate MGD. LF-treated patients had a better ocular surface status than CL

AEs

None

No pain or discomfort

Matossian 2023 [67]

Prospective, randomized,

open-label, crossover, multicenter

USA

N = 121 patients with mild-to-moderate MGD and cataract;

LF: N = 117 eyes, 65 (8) years;

CL: N = 115 eyes, 65 (8) years

3 months (3 months post-cataract surgery)

CO: 1 month (4 months post-cataract surgery)

Single 12-min LF Tx

CL: untreated

MGSS:

Change from BL to 3 months (postop):

LF: 7.3 (9.3)†

CL: 4.7 (10.1)

MGYLS Change from BL to 1 month postop:

LF: 1.6 (3.1)

CL: 1.1 (3.3)

CO MGSS:

Change from 3 to 4 months postop:

LF: 4.1 (11.0)†

SPEED:

Change from BL to 3 months:

LF: -2.1 (5.3)

CL:-1.5 (5.6)

CO SPEED:

Change from 3 to 4 months postop:

LF: − 1.2 (5.6)

TBUT

Change from BL to 1 month postop:

LF: 0.69 (4.6)

CL: 0.06 (3.7)

Corneal Change from BL to 1 month postop:

LF: − 0.57 (2.3)†

CL: 0.20 (3.2)

Conjunct

Change from BL to 1 month postop:

LF: − 1.2 (3.8)†

CL: 0.45 (4.0)

Presurgical LF Tx of

patients implanted with range-of-vision IOLs

improved MG function and postop ocular surface health. LF Tx reduced postop

halos and improved VA

AEs

None related to LF, all related to cataract surgery

Park 2021 [69]

Prospective, randomized controlled study

Korea

N = 124 patients with cataract (MGD was not a requirement) (124 eyes);

LF: N = 60 patients (60 eyes), 64 (9) years

CL: N = 48 patients (48 eyes), 65 (12) years

3 months postop

Single 12-min LF Tx

CL: untreated

MGSS

LF: 1.0 (0.9)

CL: 0.9 (0.8)

MGYLS

LF: 6.0 (2.1)

CL:6.6 (2.1)

MGSS

LF: 0.9 (0.9)*†

CL: 1.7 (0.8)*

MGYLS

LF: 7.1 (1.7)*†

CL: 5.6 (2.6)*

OSDI

LF: 37.9 (20.2)

CL: 34.3 (20.1)

OSDI

LF: 22.3 (16.5)*†

CL: 29.8 (20.8)

TBUT

LF: 3.5 (1.5)

CL: 3.7 (1.5)

TBUT

LF: 4.4 (1.8)*†

CL: 3.6 (1.6)

Corneal

LF:0.77 (0.90)

CL: 0.68 (0.92)

Corneal

LF: 0.46 (0.56)*

CL: 0.62 (0.56)

LF Tx conducted prior to cataract surgery may be safe and effective for relieving MGD and dry eye induced by surgery

AEs

None. No pain at insertion, treatment, or removal

Zhao Y 2021 [68]

Prospective, examiner-masked controlled, contralateral eye

China

N = 32 patients with MGD and cataract (64 eyes);

N = 16 patients undergoing cataract surgery, LF: N = 16 eyes, CL: N = 16 eyes, 62 (10) years;

N = 16 patients no surgery (control), LF: N = 16 eyes, CL: N = 16 eyes, 62 (2) years

In both groups LF in 1 eye and untreated contralateral eye

3 months

Single 12-min LF Tx

CL: untreated

MGYLS

LF/surgery: 2.1 (1.8)

CL/surgery: 1.9 (1.8)

LF/non-surgery: 1.8 (1.8)

CL/non-surgery: 2.6 (2.5)

MGYLS median change from BL:

LF/surgery: 4.0*

CL/surgery: − 2.0

LF/non-surgery: 3.0*

CL/non-surgery: 0.0 (P < 0.05 vs. CL/surgery)

SPEED

xx¹

SPEED

xx¹

TBUT

LF/surgery: 5.0 (2.3)

CL/surgery: 4.9 (2.6)

LF/non-surgery: 2.5 (0.6)

CL/non-surgery: 2.8 (1.1)

TBUT median change from BL:

LF/surgery: − 2.5

CL/surgery: − 2.0

LF/non-surgery: 1.0 (P < 0.05 vs. LF/surgery)

CL/non-surgery: 0.0 (P < 0.05 vs. CL/surgery)

Corneal

LF/surgery: 3.1 (0.4)

CL/surgery: 3.2 (0.5)

LF/non-surgery: 2.0 (0.5)

CL/non-surgery: 1.9 (0.8)

Corneal

xx¹

LF Tx before cataract surgery is effective in diminishing the blockage of MG and preventing a decline of TBUT after cataract surgery.

Safety NR

Szabelska 2023 [64]

Open-label case series

Poland

N = 6 patients with MGD and cataract (11 eyes), 67 years

6 weeks

Single 12-min LF Tx 6 weeks pre-cataract surgery

OSDI

LF: 31.1

OSDI

LF: 22.7

TBUT

LF: 9.1

TBUT

LF: 13.9

Stabilization of visual system parameters after LF improved accuracy of IOL power recommendation.

Safety NR

Matossian 2020 [65]

Single-center, pilot, retrospective

USA

N = 23 patients with MGD and cataract (25 eyes), 73 (8) years

6 weeks

Single 12-min LF Tx 6 weeks pre- cataract surgery

LF Tx resulted in less residual refractive astigmatism compared with pre-LF keratometry readings, which altered astigmatism management/ IOL selection.

Safety NR

Glaucoma

Kasetsuwan 2020 [70]

Prospective, randomized, observer-blind

Thailand

N = 60 patients with well-controlled glaucoma and MGD; LF: N = 26 patients (26 eyes), 67 (11) years;

CL: N = 22 patients (22 eyes), 70 (8) years

6 months

Single 12-min LF Tx plus lid hygiene

CL: lid hygiene: warm compress, massage, baby shampoo, BID for 6 months

MGSS

LF: 21.5 (5.8)

CL: 22.5 (5.9)

MGSS

change from BL:

LF: 4.7*

CL: 3.0*

OSDI

LF: 23.7 (11.8)

CL: 26.8 (18.2)

OSDI change from BL:

LF: − 7.8*

CL:

-11.8*

TBUT

LF: 5.4 (3.7)

CL: 6.0 (5.4)

TBUT

Change from BL:

LF: − 0.30

CL:-0.58

Corneal

LF: 1.3 (0.8)

CL: 1.0 (0.6)

Corneal

Change from BL:

LF: 0

CL: 0

Adding LF Tx to lid hygiene significantly improved MG function and symptoms at 6 months

AEs

LF: N = 7 patients (N = 1 difficulty inserting the device, N = 5 mild discomfort immediately after Tx, N = 1 mild conjunctival injection

CL: N = NR discomfort during massage.

No IOP elevation or uncontrolled IOP that required additional antiglaucoma Tx

Units of measure are as follows: MGSS = points, score 0–45; MGYLS = number of functional glands; NIKBUT = seconds; OSDI = points, score 0–100; SANDE = visual analog scale score, 0–100; SPEED = points, score 0–28; staining = scale score; TBUT = seconds; VAS = scale score

AEs adverse events, BID 2 times per day, BL baseline, CL control, CO crossover group, conjunct conjunctival, D diopters, DED dry eye disease, FU follow-up, IOL intraocular lens, LF LipiFlow, MG meibomian glands, MGSS number of expressible meibomian glands, MGYLS meibomian glands secretion score, min minutes, NIKBUT noninvasive keratograph break-up time, NR not reported, OSDI ocular surface disease index, pre pretreatment, post post-treatment, SD standard deviation, SPEED standard patient evaluation of eye dryness, TBUT tear break-up time, Tx treatment, VA visual acuity

^*P ≤ 0.05 vs. baseline

^†P ≤ 0.05 vs. control

¹Data only presented in a figure. We did not extrapolate the data from the figure to avoid presenting estimated data