CA2029204C - Schirmer i tear test - Google Patents

Schirmer i tear test Download PDF

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Publication number
CA2029204C
CA2029204C CA002029204A CA2029204A CA2029204C CA 2029204 C CA2029204 C CA 2029204C CA 002029204 A CA002029204 A CA 002029204A CA 2029204 A CA2029204 A CA 2029204A CA 2029204 C CA2029204 C CA 2029204C
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CA
Canada
Prior art keywords
strip
tear
test
schirmer
dye
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
CA002029204A
Other languages
French (fr)
Other versions
CA2029204A1 (en
Inventor
Jerry Gin
Vernon G. Wong
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Visionex Inc
Original Assignee
Visionex Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Visionex Inc filed Critical Visionex Inc
Publication of CA2029204A1 publication Critical patent/CA2029204A1/en
Application granted granted Critical
Publication of CA2029204C publication Critical patent/CA2029204C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/52Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements
    • G01N33/521Single-layer analytical elements
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B3/00Apparatus for testing the eyes; Instruments for examining the eyes
    • A61B3/10Objective types, i.e. instruments for examining the eyes independent of the patients' perceptions or reactions
    • A61B3/101Objective types, i.e. instruments for examining the eyes independent of the patients' perceptions or reactions for examining the tear film
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/52Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/0045Devices for taking samples of body liquids
    • A61B2010/0067Tear or lachrymal fluid
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10STECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S435/00Chemistry: molecular biology and microbiology
    • Y10S435/805Test papers

Abstract

An improved Schirmer I Tear Test is provided. The improvement comprises a strip having a graduated migration scale printed an the test strip and the presence of a water soluble marker dye that comigrates with the tear migration front. Both improvements serve to increase the reproducibility of the test and ease which with the results are read.

Description

SCHIRMER I TEAR TEST
The subject invention is in the field of ophthalmic disease diagnosis.
The ability to quantitatively measure tear production is important for the diagnosis of many types of lacrimal dysfunction. Patients may experience either excessive tear formation (epiphora) or decreased tear production, such as keratoconjunctivitis sicca (associated with Sjogren syndrome).
The measurement of tear production levels is also important for determining if a patient is a good candidate for contact lenses.
Quantitative measurement of tear production has traditionally been measured by a Schirmer I Tear Test. The standardized Schirmer I Tear Test consists of a 5x35 mm strip of Whatman* #41 filter paper; the paper has a notch located 5 mm from one end of the strip. The notched end of the strip is rounded.
The Schirmer Tear Test is performed as follows. The test strip is bent at the notch (-120° bend). The rounded end of the Schirmer I Tear Test strip is then inserted into the lower conjunctival sac of each eye. The eyes are then closed. The strip is progressively wetted by capillary action drawing up tears as they are produced. The distance the tear migration front has moved is measured after 5 minutes. The migration distance of the tears is measured from the notch of the strip as the zero point . Reading the test involves removing the strip from the eye and placing it against a scale graduated in millimeters. 15 mm of wetting in 5 minutes is considered normal.
It is imperative that the tear migration front be measured as close to the 5 minute time mark as possible because the tear front will continue to migrate up the strip after the strip is removed from the eye.
Trade-mark*

Thus, late readings give rise to results that are artificially high.
Relevant Literature Background information describing the diagnostic use of the conventional Schirmer I Tear Test is given in the following articles: Gifford et al., Archives of Ophthalmology (1943) 30:207-216; Jones et al., American Journal of Ophthalmology (1969) 5:751-754; A. De Rotth American Journal of Ophthalmology (1941) 24:20-25.
The subject invention provides for an improved version of the Schirmer I Tear Test. The improvement consists of both a tear migration front scale printed on the test strip, and a water soluble marker dye that facilitates visualization of the tear migration front. Both improvements serve to increase the reproducibility and ease with which the test results are read.
Accordingly, the present invention provides a Schirmer I
Tear Test strip comprising a graduated scale index printed on said strip for measuring the migration distance of the tear migration front, wherein said scale index is printed in water insoluble ink, and a water soluble dye that co-migrates with the tear migration front positioned proximal to the end of said strip for insertion into the conjunctival sac of the eye.
The present invention also provides a Schrimer I Tear Test strip comprising: a graduated millimetre scale index having line graduations printed along at least one side of said strip; and a spot of FD&C Blue Dye No. 1 proximal to the end of said strip for insertion into the conjunctival sac of the eye.
Improved versions of the Schirmer I Tear. Test are provided. The improvements of the test serve to increase the reproducibility and ease of reading the test results. One of the improvements in the test consists of a tear migration front scale printed directly on the test strip.
A second improvement consists of including a marking dye on the test strip so as to facilitate the visualization of the tear migration front.
The shape and material of the filter paper component of the improved Schirmer I Tear Test is essentially the same as the conventional Schirmer I Test. The improved Schirmer I Tear Test may be made from any type of filter paper currently used to manufacture conventional Schirmer I Tear Tests. Suitable filter material must be able to absorb tears by capillary action.
Filter paper used for the manufacture of the Schirmer Test will usually be ashless, non-hardened, analytical filter paper having flow characteristics similar -2a-to Whatman #41 fzlter paper. Preferably, Schirrner I Tear Test strips are made from Whitman #41 filter paper.
The shape of the subject improved Seh.irmer I Tear Test is essentially 'the same size and shape as conventional Schirmer I Tear Tests. The strip is about 5x35 mrn in size.
The strip is rounded on one end and a notch will be present about 5 mm from the rounded end of the test strip. 'She shape of the notch is not essential to the performance of the test.
The notch is usually a 90o cut, placed such that the apex of the notch does not protrude past a median 7.ongi.tudinal axis of the test strip.
The subject Schi.rmer T Tear Test contains a printed graduated scale that allows one to .rapidly and accurately measure the tear migration front without referring to a printed scale separate from 'the strip. The ink used for the printed scale is substantially water insoluble. 'Phe ink may be of any single color or of multiple colors. Preferably, the ink is o.f a single dark color. Conveniently, the ink will be black. The scale may be printed either on a single side, or both sides of the test strip for easier extrapolation where the front is not normal to the sides of the strip.
The printed scale is in unifarmly graduated in units, the normal unit being millimeters. The scale is arranged so that the distance the tear migration front travels from the conjunctival sac is conveniently measured. The low end of the scale is closest to the notched end of the strip. The scale consists of gradation lines marked with numbers so as to indicate the migration distance. Not every line need be marked with a number. In addition to the quantitative markings on the scale, the scale may also contain qualitative markings that indicate critical result ranges, e.c~., <r special mark indicating the -tear m:iclrat:Lon ci-i.stanc;e: :i.n <:r normal individual.
_. 3 The subject Schi.rmer I Tea:.r I'r-_~~;t:, a.l5o rarnr~r, ise a water soluble dye designeel to a:id visualization of the tear migration front. Suitable dyes have a migration front essential 1y coincident with the tear migration f ront .
Suitable dyes are non-'toxic, particularly those dyes have Federal Food and Drug Commission appraval. FD&C Plue Dye No, 1 is exemplary, but not exclusive of dyes that rnay be used in the subject Schirmer T Tear Test. The dye is diffusl.bly present on the test strip prior to the use of the strip.
Conveniently, the dye may be present as a linear or circular spat located near the zero paint of the printed scale, proximal to the portion of the strip introduced unto the canjunctival sac. The surface area of dye spot will be a small fraction of the surface area. of -the subject Schirmer test strip, preferably less than 5% of the surface area, more preferably less than 10 of the surface area.
The dye may be applied to the 'test strip in a variety of ways. The method of application of the dye to the test strip during manufacture is not impor'tan't to 'the function of -the test strip. Exemplary, but not exclusive of methods for applying the dye to the test strip is impact printing. The dye may be printed an either a single side ac both sides of the test strip.
The subject Schirmer I Z'ear Test strip is mairutained sterile prior to its use. The method of achieving sterilization is conventional. Exc.rnplary, but not exclusive of methods of sterilization, is sterilization by ionizing radiation. The sterilized subject Schirmer I Test strip is stored in a pouch capable of maintaining the sterility of the test prior to use.
With the exception of the method by which the subject test results are read, the subject Schirmer I Test is performed essentially as the r_onvent:ional Sch:i.rmer I 'L'e;ar Test. The test .is essent:ia7..ly per. Fc.~rrnf:d ~:~s Fo.1 Lows: Wh i 1.e still in the sterile pauch, the Sch:i.rrrier .L Tear Test strip is r~_ ~~~~e~~~~
bent at the notch. The sterile pouch :i.s -then opened anrl the rounded end of the test strip is inserted in the lower conjunctival sac near the outer angle, being careful not to touch the cornea. The eyes are then closed for 5 minutes.
At the end of 5 minutes, the distance the dye front has migrated is noted. The test need not be removed from the eye in order to be read as is presently performed.
The subject test strip provides many advantages of convenience, ease of reading, increased accuracy and reduced likelihood of erroneous results. Experience obtained with the conventional Schirmer 1 Test strip is readily applir~~ab.le in that new procedures are not. required, Although the foregoing invention has been described in some detail by way of illustration and example for purposes of clarity of understanding, it will be readily apparent to those of ordinary skill in the ax~-t in light of the teachings of this invention that certain changes and modifications may be made thereto without departing from the spirit or scope of the appended claims.
r5-

Claims (5)

1. A Schirmer I Tear Test strip comprising a graduated scale index printed on said strip for measuring the migration distance of the tear migration front, wherein said scale index is printed in water insoluble ink, and a water soluble dye that co-migrates with the tear migration front positioned proximal to the end of said strip for insertion into the conjunctival sac of the eye.
2. A strip according to Claim 1 wherein said graduated scale index has lines graduated in millimeters.
3. A strip according to Claim 1 wherein said dye is FD&C Blue No. 1.
4. A strip according to claim 1, whereas said strip is Whatman #41 paper.
5. A Schrimer I Tear Test strip comprising: a graduated millimetre scale index having line graduations printed along at least one side of said strip; and a spot of FD&C Blue Dye No. 1 proximal to the end of said strip for insertion into the conjunctival sac of the eye.
CA002029204A 1989-11-03 1990-11-02 Schirmer i tear test Expired - Lifetime CA2029204C (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US431,522 1989-11-03
US07/431,522 US5006310A (en) 1989-11-03 1989-11-03 Schirmer tear test

Publications (2)

Publication Number Publication Date
CA2029204A1 CA2029204A1 (en) 1991-05-04
CA2029204C true CA2029204C (en) 2002-12-31

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Family Applications (1)

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CA002029204A Expired - Lifetime CA2029204C (en) 1989-11-03 1990-11-02 Schirmer i tear test

Country Status (6)

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US (1) US5006310A (en)
EP (1) EP0426307B1 (en)
JP (1) JP3058340B2 (en)
CA (1) CA2029204C (en)
DE (1) DE69029246T2 (en)
ES (1) ES2095864T3 (en)

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5352445A (en) * 1992-05-07 1994-10-04 Lavaux Joseph E Lavaux tear test lacrimal equilibration time (LET)
US5997817A (en) * 1997-12-05 1999-12-07 Roche Diagnostics Corporation Electrochemical biosensor test strip
US6438398B1 (en) 1999-03-05 2002-08-20 The University Of Miami Process and device for measuring tear fluorescein clearance
WO2004006774A2 (en) * 2002-07-12 2004-01-22 Iscience Surgical Corporation Ultrasound interfacing device for tissue imaging
US7244394B2 (en) * 2002-10-03 2007-07-17 Novartis Ag Methods and kits for assays of analytes of interest in tears
JP5138967B2 (en) * 2007-04-10 2013-02-06 克史 石田 Method for producing tear meniscus test device
EP2451969A2 (en) 2009-07-07 2012-05-16 University Of Southern California Biomarkers for the early detection of autoimmune diseases
US9687523B2 (en) 2010-02-04 2017-06-27 University Of Southern California Compositions and methods for the treatment of sjörgren's syndrome
US9606117B2 (en) 2011-01-13 2017-03-28 University Of Southern California Bioassay for the early detection of autoimmune diseases
EP3029463A1 (en) * 2011-11-30 2016-06-08 DiagnosTear Ltd Dry eye diagnostic
WO2013080198A1 (en) * 2011-11-30 2013-06-06 D.E.S. Diagnostics Ltd Method for quick assessment of osmolarity
EP2992813B1 (en) * 2013-05-02 2018-10-31 Echo Electricity Co. Ltd. Liquid-testing implement
EP3288458B8 (en) 2015-05-01 2019-12-18 DiagnosTear, Ltd. Method for measuring tear constitutents in a tear sample
KR102584683B1 (en) * 2021-08-31 2023-10-05 바디텍메드(주) Dry eye discrimination method using quantitative immunoassay analysis

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3420205A (en) * 1966-03-23 1969-01-07 Miles Lab Indicating device
US3819490A (en) * 1971-12-08 1974-06-25 E Klingstrom Testing device for use when making bacteriological tests
US4095950A (en) * 1976-06-11 1978-06-20 Bio-Dynamics, Inc. Method for the chromatographic analysis of a technetium-containing mixture
US4428908A (en) * 1980-06-16 1984-01-31 Ashley Sheldon J Radionuclide quality control test kit
US4857453A (en) * 1987-04-07 1989-08-15 Syntex (U.S.A.) Inc. Immunoassay device
CA1338048C (en) * 1988-02-20 1996-02-13 Makoto Nagase Test strip for measuring tear production
JPH0714891Y2 (en) * 1989-03-20 1995-04-10 昭和薬品化工株式会社 Paper for measuring tear secretion and its packaging

Also Published As

Publication number Publication date
EP0426307B1 (en) 1996-11-27
EP0426307A3 (en) 1992-02-26
JP3058340B2 (en) 2000-07-04
EP0426307A2 (en) 1991-05-08
DE69029246D1 (en) 1997-01-09
CA2029204A1 (en) 1991-05-04
JPH03207337A (en) 1991-09-10
US5006310A (en) 1991-04-09
DE69029246T2 (en) 1997-04-24
ES2095864T3 (en) 1997-03-01

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Effective date: 20121202