Methods for diagnosing meibomian gland dysfunction

• US 8,956,311 B2
• Filed: 10/12/2011
• Issued: 02/17/2015
• Est. Priority Date: 10/13/2010
• Status: Active Grant

• Current Assignee: TearScience Inc. (Johnson & Johnson)
• Original Assignee: Tearsciecne Incorporated
• Inventors: Korb, Donald R., Blackie, Caroline, Stevens, Christy
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): Danega, Renee
• Application Number:
  US13/271,768
• Publication Number:
  US 20120265101A1
• Time in Patent Office: 1,224 Days
• Field of Search: 600/587, 604/289, 351/206
• US Class Current: 600/587
• CPC Class Codes: A61B 3/10 Objective types, i.e. instruments for examining the eyes independent of the patients' perceptions or reactions
• CPC Class Codes: A61B 5/4261 Evaluating exocrine secretion production A61B3/101 takes precedence

Abstract

Methods of diagnosing meibomian gland dysfunction are disclosed. The methods may be standardized and provide an accurate diagnosis of whether meibomian gland dysfunction exists. In one embodiment, a method is provided that utilizes an evaluation tool to apply a force for a preselected period of time to at least one of a plurality of meibomian glands in two or more regions of a plurality of regions of an eyelid. A grade is assigned to the at least one meibomian gland of the plurality of meibomian glands in each of the two or more regions based on any secretion that is expressed from each meibomian gland. In this manner, a plurality of meibomian gland secretion grades is obtained. The plurality of meibomian gland secretion grades is indicative of the presence of meibomian gland dysfunction.

Claims

1. A method of diagnosing meibomian gland dysfunction in an eye, comprising:

placing an evaluation tool on an outer portion of an eyelid;

applying a force to at least one of a plurality of meibomian glands in each of at least two regions of a plurality of regions of the eyelid for a preselected period of time using the evaluation tool, wherein the force applied by the evaluation tool is a standard constant force that simulates forceful blinking of the eyelid;

assigning a grade to the at least one of the plurality of meibomian glands in each of the at least two regions of the plurality of regions based on any secretion that is expressed from each meibomian gland to obtain a plurality of meibomian gland secretion grades indicative of a presence of meibomian gland dysfunction; and

summing the plurality of meibomian gland secretion grades to obtain a total meibomian gland secretion score, wherein the total meibomian gland secretion score is indicative of the presence of meibomian gland dysfunction.

2. The method of claim 1, further comprising applying the force to four to six meibomian glands in each of three regions of the eyelid and a grade is assigned to each of these meibomian glands.

10. The method of claim 1, wherein the standard constant force is between ten (10) grams per thirty (30) mm² and forty (40) grams per thirty (30) mm².

11. The method of claim 1, wherein the preselected period of time is between approximately ten (10) and fifteen (15) seconds.

12. The method of claim 1, wherein the plurality of regions comprises a temporal region, a central region, and a nasal region.

13. The method of claim 1, further comprising summing the plurality of meibomian gland secretion grades for at least one region of the plurality of regions to get a regional meibomian gland secretion score, wherein the regional meibomian gland secretion score is indicative of whether there is meibomian gland dysfunction.

14. The method of claim 1, wherein applying the force further comprises placing the evaluation tool on an outer portion of the eyelid, rotating a shaft of the evaluation tool downward, and depressing the evaluation tool approximately three (3) millimeters (mm).

15. The method of claim 1, wherein the plurality of meibomian gland secretion grades indicates that meibomian gland dysfunction is likely.

16. The method of claim 15, further comprising treating the meibomian gland dysfunction.

17. The method of claim 16, wherein the treating the meibomian gland dysfunction varies based on the plurality of meibomian gland secretion grades.

3. A method of diagnosing meibomian gland dysfunction in an eye, comprising:

placing an evaluation tool on an outer portion of an eyelid;

applying a force to at least one of a plurality of meibomian glands in each of at least two regions of a plurality of regions of the eyelid for a preselected period of time using the evaluation tool, wherein the force applied by the evaluation tool is a standard constant force that simulates forceful blinking of the eyelid; and

assigning a grade to the at least one of the plurality of meibomian glands in each of the at least two regions of the plurality of regions based on any secretion that is expressed from each meibomian gland to obtain a plurality of meibomian gland secretion grades indicative of a presence of meibomian gland dysfunction,

wherein the grade assigned to each of the meibomian glands is a first grade for clear liquid secretion;

a second grade for cloudy liquid secretion;

a third grade for a secretion having an inspissated/toothpaste consistency; and

a fourth grade for no secretion.

4. The method of claim 3, further comprising summing the plurality of meibomian gland secretion grades to obtain a total meibomian gland secretion score.

5. The method of claim 4, wherein the first grade is a three (3), the second grade is a two (2), the third grade is a one (1), and the fourth grade is a zero (0), and a total meibomian gland secretion score of 12 or less is indicative of the presence of meibomian gland dysfunction.

6. The method of claim 3, further comprising summing the number of meibomian glands of the plurality of meibomian glands having a first grade or a second grade to get a meibomian glands yielding liquid secretion (MGYLS) score that is indicative of the presence of meibomian gland dysfunction.

7. The method of claim 3, further comprising summing the number of meibomian glands of the plurality of meibomian glands having a first grade to get a meibomian glands yielding clear secretion (MGYCS) score that is indicative of the presence of meibomian gland dysfunction.

8. The method of claim 7, wherein a MGYCS score of 4 or less is indicative of the presence of meibomian gland dysfunction.

9. The method of claim 7, wherein a MGYCS score of 9 or greater is indicative that meibomian gland dysfunction is unlikely.

18. A method of diagnosing meibomian gland dysfunction in an eye, comprising:

placing an evaluation tool on an outer portion of an eyelid;

applying a force to at least one of a plurality of meibomian glands in each of at least two regions of a plurality of regions of the eyelid for a preselected period of time using the evaluation tool, wherein the force applied by the evaluation tool is a standard constant force that simulates forceful blinking of the eyelid; and

assigning a grade to the at least one of the plurality of meibomian glands in each of the at least two regions of the plurality of regions based on any secretion that is expressed from each meibomian gland to obtain a plurality of meibomian gland secretion grades indicative of a presence of meibomian gland dysfunction; and

summing the plurality of meibomian gland secretion grades for each of the plurality of regions to get a plurality of regional meibomian gland secretion scores, wherein one or more of the regional meibomian gland secretion scores are weighted more heavily to get a weighted meibomian gland secretion score and the weighted meibomian gland secretion score is indicative of whether there is meibomian gland dysfunction.

19. The method of claim 18, wherein more weight is given to the regional meibomian gland secretion scores for the meibomian glands in the central region and the nasal region.

20. The method of claim 18, wherein more weight is given to the regional meibomian gland secretion scores for the meibomian glands in the nasal region.