Table 5.
Summary of retrospective studies evaluating LipiFlow to treat MGD
| Author/design/country | Patients (eyes)/age, mean (SD) | Last FU | Study arms | MG function, mean (SD) | Patient-reported outcomes Mean (SD) |
NITBUT/TBUT, mean (SD) | Staining | Overall conclusion and safety | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pre | Post | Pre | Post | Pre | Post | Pre | Post | |||||
|
Chung 2022 [56] Retrospective South Korea |
N = 23 patients with refractory MGD (23 eyes), 42 (13) years | 12 months | 12-min LF Tx plus IPL plus MGX all 3 times (once every 3 weeks); followed by IPL plus MGX monthly through 18 weeks; followed by MGX, monthly through 12 months |
MGE Grade Score BL: 2.6 (0.6) Note: graded 0–3 |
MGE Grade Score 1.2 (0.6)* |
OSDI BL: 49.0 (14.9) |
OSDI 15.5 (8.7)* |
NIBUT BL: 3.2 (1.2) |
NIBUT 8.0 (1.9)* |
NR | NR |
LF combination Tx was effective and safe for treating refractory MGD with prolonged effects maintained with monthly MGX AEs N = 3 (gritty sensation with mild discharge for 1 day). No sign changes in VA |
|
Kim 2020 [57] Retrospective South Korea |
N = 30 patients with obstructive MGD (60 eyes); LF: 15 patients (30 eyes); 40 (7) years CL: 15 patients (30 eyes), 39 (11) years |
6 months |
12-min LF Tx 3 times (1x/month for 3 months) CL: Single 12-min LF Tx followed by MGX 3 times (1x/month for 3 months) All eyes had artificial tears containing 0.1% hyaluronic acid (Haylene) 3 × or 4x/day for 6 months |
NR | NR |
OSDI LF: 43.6 (10.4) CL: 51.3 (15.5) |
OSDI LF: 33.3 (13.2)* CL: 13.1 (6.9)*† |
NIBUT LF: NR1 CL: 3.2 (1.2) |
NIBUT LF: NR1 CL: 8.5 (1.5)*† |
NR | NR |
Both LF only and MGX after LF were clinically effective for obstructive MGD. Efficacy and persistence were greater in the MGX plus LF group AEs None |
|
Hura 2020 [52] Retrospective, single masked USA |
N = 43 patients with DED and MGD (70 eyes); LF: N = 30 patients (48 eyes), age NR; CL: N = 13 patients (22 eyes), age NR |
12 months |
Single 12-min LF Tx CL: untreated but LF recommended |
MGSS LF: 5 CL: 7 |
MGSS LF: 12*† CL: 6 |
SPEED LF: 15 CL:12 |
SPEED LF: 10 CL: 9 |
TBUT LF: 3 CL: 4 |
TBUT LF: 7*† CL: 3 |
Corneal LF: 0.44 CL: 0.39 Note: score 1 = presence and 0 = absence |
Corneal LF: 0 31*† CL: 0.67 |
Compared with CL, MG structure may increase post-LF Tx suggesting restored acini activity. Safety NR |
|
Arita 2021 [58] Retrospective, randomized Japan |
N = 165 patients with MGD (165 eyes); LF: 30 patients/eyes, 63 (14) years; CL 1: 30 patients/eyes, 59 (19) years; CL 2: 30 patients/eyes, 59 (15) years; CL 3: 38 patients/eyes, 60 (16) years; CL 4: 37 patients/eyes, 61 (18) years |
1 month |
Single 12-min LF Tx plus warm compress and lid hygiene BID for 1 month CL1: warm compress and lid hygiene BID for 3 months CL 2: Artia MG compressor every 3 weeks for 4 times plus warm compress and lid hygiene BID for 3 months CL 3:Azithromycin eyedrops plus warm compress and lid hygiene BID for 2 weeks CL 4: IPL (M22) every 3 weeks for 4 sessions plus warm compress and lid hygiene BID for 3 months |
MGE Grade Score LF: 2.3 (0.4) CL 1: 2.3 (0.5) CL 2: 2.4 (0.5) CL 3: 2.3 (0.4) CL 4: 2.6 (0.5) Note: graded 0–3 |
MGE Grade Score LF: 1.7 (1.0)* CL 1: 1.8 (0.9)* CL 2: 1.6 (0.9)* CL 3: 1.2 (0.8)* CL 4: 0.1 (0.4)* |
SPEED LF:11.3 (3) CL 1: 12.2 (3.9) CL 2: 12.5 (4.2) CL 3: 12.6 (4) CL 4: 13.4 (3.2) |
SPEED LF: 8.7 (4.2)* CL 1: 9.0 (3.6)* CL 2: 8.9 (4.9)* CL 3: 6.2 (4.5)* CL 4: 3.7 (2.8)* |
TBUT LF: 3.3 (0.7) CL 1: 3.1 (1.2) CL 2: 3.0 (1.1) CL 3: 3.2 (1.0) CL 4: 3.1 (1.2) |
TBUT LF: 3.1 (1.7)* CL 1: 3.4 (1.3)* CL 2: 3.9 (0.6)* CL 3: 5.8 (2.8) CL 4: 6.7 (2.4)* |
Corneal + Conjunct LF: 0.9 (0.6) CL 1: 0.8 (0.6) CL 2: 0.8 (0.8) CL 3: 1.0 (1.2) CL 4: 1.0 (1.1) Note: Score 0–9 |
Cornea + Conjunct LF: 0.8 (0.6)* CL 1: 0.6 (0.6)* CL 2: 0.5 (0.7)* CL 3: 0.4 (1.0)* CL 4: 0.1 (0.3)* |
When MG loss is early and mild or moderate, several Tx options are available. When MG loss is severe, IPL is recommended. Safety NR |
|
Kim 2017 [53] Retrospective chart review USA |
N = 98 patients with MGD and DED (189 eyes), 60 years | Mean 77 days | Single 12-min LF Tx | NR | NR |
OSDI LF: 50.5 (25.1) |
OSDI LF: 41.4 (26.4)* |
TBUT LF: 4.5 (1.4) |
TBUT LF: 8.5 (1.7)* |
NR | NR |
LF Tx improves subjective and objective measures of DED. Safety NR |
|
Gibbons 2017 [59] Retrospective interventional case series USA |
N = 49 patients with symptomatic MGD (98 eyes); N = 32 patients who responded to Tx, 63 (15) years; N = 17 patients with no response to Tx, 62 (16) years |
3–4 months | Single 12-min LF Tx followed by 10 min heat (gel mask), lid hygiene, and MGX every 4–6 weeks for 3 times |
MGE Grade Score LF responded to Tx: 5.9 (1.9) LF no response to Tx: 5.6 (1.9) Note: grading not defined |
MGE Grade Score NR |
OSDI LF responded to Tx: 54.0 (24.3) LF no response to Tx: 57.6 (19.9) |
OSDI NR |
TBUT LF responded to Tx: 4.1 (3.0) LF no response to Tx: 4.6 (3.5) |
TBUT NR |
Corneal LF responded to Tx: 4.4 (5.0) LF no response to Tx: 0.4 (1.1) Conjunct LF responded to Tx: 3.1 (2.4) LF no response to Tx: 1.5 (1.8) |
Corneal NR† Conjunct NR† |
Patients with signs of lower tear production, higher corneal and conjunct staining scores, and higher osmolarity tend to respond better to LF AEs None |
|
Epitropoulos 2017 [54] Retrospective USA |
N = 59 patients with MGD (102 eyes), 62 (14) years; LF SS+: N = 23 patients (43 eyes); LF SS-: N = 36 patients (59 eyes) |
2 months | Single 12-min LF Tx |
MGSS LF SS +: 2.1 LF SS-: 2.4 |
MGSS LF SS+: 13.0* LF SS-: 15.9*† |
SPEED LF SS+: 17.9 LF SS-: 15.9 |
SPEED LF SS+: 12.5* LF SS-: 10.1* |
TBUT LF SS+: 3.7 LF SS-: 3.8 |
TBUT LF SS+: 9.6* LF SS-: 8.3* |
NR | NR |
LF Tx in patients SS+ and with MGD had significant improvement in signs and symptoms of dry eye. Improvement in MGS scores were > in SS- patients. Safety NR |
|
Liang 2015 [55] Retrospective case series China |
N = 48 patients with MGD (96 eyes) | 3 months | Single 12-min LF Tx |
MGSS LF: 6.2 (2.5) MGYLS LF: 2.9 (1.1) |
MGSS LF: 12.7 (3.4)* MGYLS LF: 5.2 (2.1)* |
OSDI LF: 45.4 (19.3) |
OSDI LF: 25.7 (14.1)* |
TBUT LF: 4.7 (2.3) |
TBUT LF: 9.9 (3.0)* |
Corneal + Conjunct LF: 2.4 (2.2) |
Corneal + Conjunct LF: 2.1 (1.1) |
LF is an effective and safe Tx for MGD AEs None No discomfort /pain, tearing, or irritation 1 day post Tx. No sign changes in VA or IOP |
Units of measure are as follows: MGSS = points, score 0–45; NIKBUT = seconds; OSDI = points, score 0–100; SPEED = points, score 0–28; staining = scale score; TBUT = seconds
Treatment manufacturers are as follows: Artia MG compressor (Katena Products/Corza Medical, Parsippany, NJ); Azithromycin eyedrops (Azimychin, Senju Pharmaceutical Co, Kobe, Japan); Haylene Eye Drop (Binex Pharmaceutical Corp, Incheon, Korea); M22 (Lumenis, Yokneam, Israel)
AEs adverse events, BID 2 times per day, BL baseline, CL control, conjunct conjunctival, FU follow-up, IPL intense pulsed light, LF LipiFlow, MG meibomian glands, MGD meibomian gland dysfunction, MGE meibomian gland expression, MGSS meibomian gland secretion score (secretion quality), MGX practitioner-administered manual meibomian gland expression, MGYLS meibomian glands yielding liquid secretion (glands with secretion capacity), min minutes, NIKBUT noninvasive keratograph break-up time, NR not reported, OSDI ocular surface disease index, SD standard deviation, sign significant, SPEED standard patient evaluation of eye dryness, SS ± Sjögren’s syndrome positive or negative, TBUT tear break-up time, Tx treatment, VA visual acuity
1Data only presented in a figure. We did not extrapolate the data from the figure to avoid presenting estimated data
*P < 0.05 vs. baseline
†P < 0.05 vs. comparator