Intraductal Meibomian Gland Probing for Meibomian Gland Dysfunction Using VAS Testing (updated ) DISCLOSURE: Patent Pending Class One Device Made of Stainless Steel. COMMERCIAL RELATIONSHIP: Rhein Medical, Inc. Steven L. Maskin, MD FACS Dry Eye and Cornea Treatment Center Tampa Florida

Meibomian Gland Disease is arguably the most common cause of Dry Eye and has certainly been the most challenging to treat. Traditional therapies have failed to consistently provide effective results leading to ongoing suffering and frustration for patients and physicians alike. BACKGROUND:

PURPOSE : To evaluate results of Intraductal Meibomian Gland probing for lid tenderness using a standardized VAS test. METHODS : Intraductal Meibomian Gland probing as previously described in ARVO abstract 2009 was performed on patients with pre probing lid tenderness in the setting of Meibomian Gland Dysfunction. Data was collected prospectively. Pre probing lid tenderness was evaluated using a standardized VAS with post probing VAS responses at various post probing time points including immediately, weekly for the first month, then monthly. Inclusion criteria required pre probing VAS to be greater than 25mm.

RESULTS : Average patient age was with a range from Fifty nine (59) lids of 24 patients were probed with a pre probing VAS mean score of mm. There was an immediate reduction of mean VAS score of mm (75.3%) to 14.5 mm. Lid tenderness continued to improve to a reduction of mean VAS score of mm (81.1%) between one week and one month, mm (76.6%) reduction between 1 and 3 months and mm (85.1%) reduction between 3 and 6 months. Twenty one (21) lids of 8 patients have reached the 3 to 6 month follow up visit. The average last measurement was 11.8mm, an average reduction of 80% at an average follow up of months.

Average of Difference (mm) (Preprobing - Post Probing) Total # of PatientsTotal # of Lids IMMEDIATE44.1 (SD ± 21.2)2457 ≤ 1 WEEK44.7 (SD ± 14.9)820 ˃ 1 WEEK ≤ 1 MONTH 47.5 (SD ± 24.3)1551 ˃ 1 MONTH ≤ 3 MONTHS 44.8 (SD ± 23.5)1553 ˃ 3 MONTHS ≤ 6 MONTHS 49.8 (SD ± 21.7)821 Mean Score (mm)Total # of PatientsTotal # of Lids PREPROBING58.5 (SD ± 18.9)2459 IMMEDIATE POSTPROBING 14.5 (SD ± 18.1)2457 LAST MEASUREMENT11.8 (SD ± 19.9)2459 AVERAGE LAST FOLLOW UP DATE 2.4 (SD ± 1.81)2459 MEIBOMIAN GLAND PROBING WITH LID TENDERNESS PATIENTS WITH VAS TESTING ≥ 25 Range of Patient Age: (SD ± 18.4) Average Patient Age: 64

Results of Meibomian Gland Probing on VAS For Symptoms of MGD With Lid Tenderness 44.8 ± 23.5 (77%) 47.5 ± 24.3 (81%) 49.8 ± 21.7 (85%) ˃1 WEEK ≤ 1 MONTH n =15 l = 51 ˃ 1 MONTH ≤ 3 MONTHS n = 15 l = 53 ˃ 3 MONTHS ≤ 6 MONTHS n = 8 l = 21 IMMEDIATE n = 24 l = 57 n = number of patients l = number of lids 44.1 ± 21.2 (75%) PREPROBING

Results of Meibomian Gland Probing On VAS For Symptoms of MGD With Lid Tenderness

FINDINGS : Probing often identified four findings. Three findings were of variable resistance which may be present in each gland. These included: (1) orifice resistance, (2) a mostly proximal gritty sensation like piercing through a “rice krispy”, and (3) moderate resistance which released with a “pop” and is usually deeper in the duct and suggestive of fibrovascular tissue. The fourth finding was frequent orifice hemorrhages which were self limited. There were no probe fractures in this study. There were no adverse sequelae. TECHNIQUE: We Use 1, 2, 4, and 6 mm stainless steel sterile solid wire probe cannulas with attached ergonomic handle.

With TransilluminationWithout Transillumination The lid margin and glands were examined with and without transillumination to evaluate patency of orifice and status of the glands, specifically looking at gland proximal and distal atrophy, length of glands and signs of ductal dilation suggestive of proximal obstruction. Glands were palpated individually for gland tenderness seen with inflammation and obstruction.

PENETRATION WITH A 2MM PROBE. NOTE HEMORRHAGE AT ORIFICE OF ADJACENT GLAND. A PLUG OF SEQUESTERED MEIBUM. Topical tetracaine or lidocaine gel anesthetic was applied to the lid margin. In some cases discomfort with probing required additional direct application of 4% lidocaine solution. The 1 or 2 mm probes were passed through the orifice. At times a fine router movement was needed to find the opening, especially in setting of orifice metaplasia. After penetrating the orifice with the 1 or 2 mm, the 4 or 6 mm probe was then used depending on the length of the gland to achieve complete patency of the ductal highway. At times resistance was encountered. Respecting the length of the gland prevented extending the probing too far. Therefore, if resistance was obtained, the probe was felt to be against a fibrotic band. After checking to ensure the probe was co-linear to the gland, additional mild force was used to pop through the intraductal fibrotic tissue. A dot hemorrhage was frequently noticed at the orifice.

Before Intraductal Probing After Intraductal Probing Pre probing photo on left shows appearance of left upper lid with lid margin vascular engorgement and gland plugging. The photo on the right is two months later after gland probing showing vessel regression with marked reduction in vascular caliber and gland plugging. There was an associated marked reduction in lid tenderness VAS from pre probing score of 45 out of 100 to his latest score of 4, 2 months post probing. 80 Year Old Man With Obstructive Meibomian Gland Dysfunction.

CONCLUSIONS : 1)Intraductal Meibomian Gland probing appears highly effective in rapidly reducing standardized VAS patient scores of lid tenderness associated with Meibomian Gland Dysfunction. 2) VAS scores remain markedly improved for at least 3-9 months. 3) Three levels of probing resistance and orifice hemorrhage frequency may enable a grading scale of meibomian gland dysfunction for clinical use. 4) Additional topical anesthetic is required by some patients to tolerate meibomian gland probing. Steven L. Maskin, MD FACS Dry Eye and Cornea Treatment Center Tampa Florida