Table 3.
Summary of prospective, masked (non-randomized) 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) |
NIKBUT/TBUT Mean (SD) |
Staining | Overall conclusion and safety | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pre | Post | Pre | Post | Pre | Post | Pre | Post | |||||
|
Dierker 2022 [36] Single-center, open-label, prospective, non-randomized, subject-masked, sham-controlled USA |
N = 20 patients with MGD, 59 (11) years; LF: 19 eyes, CL: 19 eyes |
3 months |
Single 12-min LF Tx plus Dex intracanalicular insert CL: Single 12-min LF Tx plus sham punctal dilation |
MGSS LF/Dex: 13.3 (8.1) LF/CL: 16.3 (8.0) |
MGSS LF/Dex: 29.8*† (9.9) LF/CL: 27.3 (11.4)* |
NR | NR |
TBUT LF/Dex:3.2 (2.2) LF/CL: 4.1 (3.4) |
TBUT LF/Dex: 6.1 (4.8)*† LF/CL: 4.7 (3.4) |
Corneal + Conjunct LF/Dex: 6.6 (6.3) LF/CL: 5.2 (4.7) |
Corneal + Conjunct LF/Dex: 5.7 (5.9) LF/CL: 6.2 (6.5) |
Dex provides additional therapeutic benefit when combined with LF for improving signs of DED AEs None, IOP and VA remained stable in both groups |
|
Laufenböck 2022 [37] Prospective, non-masked, single-center Austria |
N = 30 patients with DED and MGD, LF: 15 patients (30 eyes), 63 (7) years CL: 15 patients (30,eyes) 61 (6) years |
3 months |
Single 12-min LF Tx plus hyaluronic acid eye drops 3x/day CL: Daily massage plus hyaluronic acid eye drops 3x/day |
MGYLS (yes/no scale)1 LF:1.8 CL: 1.9 |
MGYLS (yes/no scale)1 LF:1.4† CL: 1.75 |
OSDI LF: 22.2 CL: 22.7 |
OSDI LF: 14.2† CL: 18.5 |
NIKBUT LF: 6.8 CL: 6.7 |
NIKBUT LF: 11.2† CL: 8.3 |
NR | NR |
Both Tx improved measures of MGD but more strongly in the LF group. AEs NR. Safety parameters (IOP and VA) were normal in all patients |
|
Zhao 2016 [38] Prospective, examiner-masked, contralateral eye (worst eye treated) China |
N = 29 Chinese patients with MGD (58 eyes), 57 (7) years; LF: 29 patients (29 eyes); CL: 29 patients (29 eyes) |
3 months |
Single 12-min LF Tx CL: untreated |
MGYLS LF: 1.78 (1.8) CL: 2.34 (1.9) |
MGYLS LF: 4.75 (3.1)*† CL: xx2 |
SPEED LF: 11.2 (4.9) CL: xx2 |
SPEED LF: 4.6 (3.4)* CL: xx2 |
TBUT LF: 2.5 (0.8) CL: 2.8 (1.0) |
TBUT LF: 3.5 (1.4)*† CL: xx1 |
Corneal LF: 2.3 (1.8) CL: 1.6 (0.7) |
Corneal LF: 1.3 (1.5)* CL: xx2 |
LF significantly improved objective measures of MGD compared with the contralateral eye. Safety NR |
Units of measure are as follows: MGSS = points, score 0–45; MGYLS = number of functional glands; NIKBUT = seconds; OSDI = points, score 0–100; SPEED = points, score 0–28; staining = scale score; TBUT = seconds
AEs adverse events, CL control, conjunct conjunctival, DED dry eye disease, dex dexamethasone, IOP intraocular pressure, FU follow-up, LF LipiFlow, MG meibomian glands, MGD meibomian gland dysfunction, MGSS meibomian gland secretion score (secretion quality, max 45 points), 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, 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
1The only details on this scale provided are “the expression functionality of the meibomian glands using Meibomian Gland Evaluator: Yes/no test, whether meibum can be expressed with the defined pressure on the eyelid”
2Data 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. control