Process and device for measuring tear fluorescein clearance
First Claim
Patent Images
1. A process of measuring tear clearance from a mammalian eye, comprising:
- (a) instilling an effective amount of fluorescein dye solution into an inferior conjunctival sac of an eye;
(b) incubating the fluorescein dye solution in the conjunctival sac for a period of time sufficient to allow dye to mix with tear fluid;
(c) collecting a sample of the tear fluid from the eye;
(d) determining the volume of the tear fluid collected; and
(e) measuring an amount of fluorescence present in the tear fluid by comparison with a color standard.
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Abstract
A method of evaluating clearance of fluorescein dye instilled into tear film having a greater sensitivity and specificity for diagnosing a tear film disorder as the cause of a patient'"'"'s ocular irritation and ocular surface disease than can be achieved using the traditional methods. The inventive method can be performed using a diagnostic kit for evaluating tear fluorescence clearance in which the concentration of tear fluorescein is visually quantified via a color standard.
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Citations
32 Claims
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1. A process of measuring tear clearance from a mammalian eye, comprising:
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(a) instilling an effective amount of fluorescein dye solution into an inferior conjunctival sac of an eye;
(b) incubating the fluorescein dye solution in the conjunctival sac for a period of time sufficient to allow dye to mix with tear fluid;
(c) collecting a sample of the tear fluid from the eye;
(d) determining the volume of the tear fluid collected; and
(e) measuring an amount of fluorescence present in the tear fluid by comparison with a color standard. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10)
collecting volumes of tear fluid between 0.5 μ
l and 3 μ
l on a substrate, andcomparing the color of the fluorescein-stained substrate to a color standard.
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8. The method of claim 7, wherein the color standard comprises a standard visual scale having scores ranging from 0 to 6, wherein a score of 3 corresponds to a fluorometric value of 274 fluorescein units/μ
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9. The process according to claim 1, wherein the amount of fluorescence present in tear fluid is measured directly from an inferior tear meniscus.
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10. The process according to claim 9, wherein the amount of fluorescence present in tear fluid is directly measured from the inferior tear meniscus using a color standard viewed simultaneously with the inferior tear meniscus under a biomicroscope.
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11. A process of detecting at least one ocular abnormality affecting tear flow, said process comprising:
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(a) instilling an effective amount of fluorescein dye solution into an inferior conjunctival sac of an eye;
(b) incubating the fluorescein dye solution in the conjunctival sac for a period of time sufficient to allow the dye to mix with tear fluid;
(c) collecting a sample of tear fluid from the eye;
(d) determining the volume of tear fluid collected; and
(e) measuring the amount of fluorescence present in the tear fluid. - View Dependent Claims (12, 13, 14, 15, 16)
collecting volumes of tear fluid between 0.5 μ
l to 3 μ
l on a substrate, andcomparing the color of the fluorescein-stained substrate to a color standard.
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14. The process according to claim 13, wherein the substrate comprises a member selected from the group consisting of a filter paper strip and a polyester wick.
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15. The process according to claim 13, wherein the color standard comprises a standardized visual scale having scores ranging from 0 to 6, wherein a score of 3 corresponds to a fluorophotometric value of 274 fluorescein units/μ
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16. The process according to claim 15, wherein sensitivity of measurements from the standardized visual scale are increased according to correction formula II:
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wherein coefficient y corresponds to an area under a Receiver Operating Characteristic (ROC) curve and the Schirmer score is obtained using Schirmer test strips placed over an eyelid margin.
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17. A process of detecting at least one ocular abnormality affecting tear flow, said process comprising:
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(a) instilling an effective amount of fluorescein dye solution into conjunctival sac of an eye;
(b) incubating the fluorescein dye solution in the conjunctival sac for a period of time sufficient to allow dye to mix with tear fluid;
(c) examining the eye surface with a biomicroscope to observe corneal fluorescein staining in each of four corneal quadrants;
(e) measuring fluorescence observed to obtain a corneal fluorescein staining score; and
(f) correlating the corneal fluorescein staining score with results from a Fluorescein Clearance Test (FCT) corrected according to correction formula I;
- View Dependent Claims (18)
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19. A diagnostic kit for measuring tear clearance comprising:
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(a) an indicator suitable for introduction into an inferior conjunctival sac of an eye, the indicator comprising a member selected from the group consisting of a dye, an enzyme and a chemical; and
(b) a color standard for measuring indicator present in an inferior meniscus of an eye between about 5 and about 15 minutes after introduction of the indicator to the eye, wherein the color standard comprises a standardized visual scale having scores corresponding to clinically relevant measures of tear clearance.
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20. A diagnostic kit for measuring tear clearance comprising:
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(a) a fluorescein dye solution suitable for introduction into an inferior conjunctival sac of an eye;
(b) a substrate for collecting a sample of tear fluid from the eye; and
(c) a color standard for measuring the amount of fluorescence preset in the tear fluid, wherein the color standard comprises a standardized visual scale having scores corresponding to clinically relevant measures of tear clearance. - View Dependent Claims (21, 22, 23, 24, 25)
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26. A process of measuring tear clearance from a mammalian eye, comprising:
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(a) instilling an effective amount of an indicator solution into an inferior conjunctival sac of an eye, the indicator comprising a member selected from the group consisting of a dye, an enzyme and a chemical;
(b) incubating the indicator solution in the conjunctival sac for a period of time sufficient to allow indicator to mix with tear fluid; and
(c) collecting a sample of tear fluid from the eye;
(d) determining the volume of tear fluid collected; and
(e) measuring the amount of indicator in the tear fluid by comparison with a color standard, wherein the color standard comprises a standardized visualized scale having scores ranging from 0 to 6, wherein a score of 3 indicates the cut-off value between normality and abnormality. - View Dependent Claims (27, 28)
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29. A process of measuring tear clearance from a mammalian eye, comprising:
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(a) instilling an effective amount of an indicator solution into an inferior conjunctival sac of an eye, the indicator comprising a member selected from the group consisting of a dye, an enzyme and a chemical;
(b) incubating the indicator solution in the conjunctival sac for a period of time sufficient to allow indicator to mix with tear fluid; and
(c) measuring the amount of indicator in the tear fluid by comparison with a color standard, wherein the color standard comprises a standardized visualized scale having scores ranging from 0 to 6, wherein a score of 3 indicates the cut-off value between normality and abnormality. - View Dependent Claims (30, 31, 32)
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Specification