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 Table of Contents  
Year : 2019  |  Volume : 14  |  Issue : 4  |  Page : 342-345

A comparative clinical study of the precorneal tear film in diabetic and nondiabetic persons

Department of Ophthalmology, Jawaharlal Nehru Medical College, Datta Meghe Institute of Medical sciences, Wardha, Maharashtra, India

Date of Submission06-Nov-2019
Date of Decision06-Dec-2019
Date of Acceptance22-Dec-2019
Date of Web Publication16-Jul-2020

Correspondence Address:
Dr. Yash Hada
63, Geetanjali, Rajput-Boarding, Ratlam - 457 001, Maharashtra
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/jdmimsu.jdmimsu_176_19

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Context: The study objective was to compare precorneal tear film in terms of amount and stability in diabetic and nondiabetic individuals. Aims: The aim was to study the effect of diabetes on the amount and stability of precorneal tear film. Settings and Design: This is a hospital-based, prospective, case–controlled, observational study of 1-year duration. Sixty-five sequentially collected patients with diabetes and 65 age- and sex-matched nondiabetics, attending the ophthalmology outpatient department/inpatient department at AVBRH were selected for the study after taking the inclusion and exclusion criteria into consideration. Informed consent was taken from all participants after approval by the Institutional Ethical Committee of the college. Subjects and Methods: After enrollment of the participants to the study, all underwent a thorough ophthalmic examination. Tear film break-up time (TBUT) and Schirmer's test without anesthesia followed by with anesthesia were calculated. Statistical Analysis Used: Statistical analysis was done by using descriptive and inferential statistics using Chi-square test and Student's unpaired t-test, SPSS 17.0 version and GraphPad 6.0 version software were used in the analysis, and P <0.05 was considered as level of statistical significance (P < 0.05). Results: Patients with diabetes showed more unstable tear film as compared to nondiabetics of the same age and sex. The amount of tear film measurement also decreases in diabetics. A higher number of positive test results for both Schirmer's test and TBUT test were found in patients having duration of diabetes > 5 years. Conclusions: Longer duration of diabetes is associated with dry eye. Diabetes is associated with reduction in the amount of precorneal tear film as well as an unstable precorneal tear film.

Keywords: Diabetes, dry eye, keratoconjunctivitis sicca, Schirmer's test, tear film, tear film break-up time

How to cite this article:
Hada Y, Banait S. A comparative clinical study of the precorneal tear film in diabetic and nondiabetic persons. J Datta Meghe Inst Med Sci Univ 2019;14:342-5

How to cite this URL:
Hada Y, Banait S. A comparative clinical study of the precorneal tear film in diabetic and nondiabetic persons. J Datta Meghe Inst Med Sci Univ [serial online] 2019 [cited 2021 Jul 25];14:342-5. Available from: http://www.journaldmims.com/text.asp?2019/14/4/342/289844

  Introduction Top

Among the many predisposing factors responsible for the condition of dry eye is diabetes. Retinopathy caused due to diabetes is a well-known complication, and these patients also have symptoms which point toward dry eye such as feeling of something in eye, itching, blurring of vision, stinging, ocular discomfort, photophobia, and redness in eye. All these are not only associated with errors of refraction, but also with dry eye. Studies have shown that dryness is associated with diabetes of different duration. One may point out here that why someone should put emphasis on a symptom like dry eye? Answer to this is simple, these symptoms affect one's quality of life. It makes patient seek multiple visits to hospital with no significant relief. We have to be vigilant in every aspect to deal with a disease like diabetes. This research work gives emphasis for the same.

  Subjects and Methods Top

Sequentially collected patients with diabetes and age- and sex-matched nondiabetics, attending the ophthalmology inpatient department, were selected for the study after taking the inclusion and exclusion criteria into consideration. Informed consent was taken from all participants after approval by the Institutional Ethical Committee of the college.

Sample size was calculated by using the following formula:

n = Z2α/2 P (1 − P)/d2

  • Z2α/2 is the level of significance at 5%, i.e. 95% confidence interval = 1.96
  • P = prevalence of diabetes in India = 8.8
  • =0.088
  • d = desired error of margin = 7% = 0.07
  • n = 1.962 × 0.088× (1 – 0.088)/0.072
  • 62.92 = 65 patients were required in each group
  • A total of 65 patients were required in each group (diabetics and nondiabetics).

Procedure for test

  • Tear film break-up time (TBUT) test was performed by staining the tear film using a fluorescein strip without using topical anesthesia and asking the participants to blink several times for few seconds to encourage its distribution. The tear film was observed using a blue cobalt filter without artificially holding the lids open. The interval between the last blink and the appearance of the first corneal dry spot in the stained tear film was measured. A value of TBUT test ≤10 s shows a positive test result[1]
  • For Schirmer's test without previously instilling anesthetic drops, the Schirmer's strips were inserted into the lower conjunctival sac at the junction of the lateral and middle thirds, avoiding touching the cornea, and the length of wetting strips in millimeters was recorded after 5 min. Value of Schirmer's test ≤10 mm shows a positive test result;[2] 15 min later, the strips were placed over the same point in the same person again for 5 min, after topical anesthesia with 0.5% proparacaine hydrochloride twice at 1-min interval, and then the length of wetting was read. The tests above were administered by the same person at the same time and the same place. All patients were seated at rest with their eyes closed, and the lower cul-de-sac was gently dried with a cotton applicator before the placement of strip.[2] Positive test implies <5 mm wetting of Schirmer's strip at 5 min, which shows the evidence of ocular surface being dry.[3]

Inclusion criteria

  • Known diabetic patients (of either sex, 18 years and above, diagnosed to have diabetes mellitus Type 2 of any duration)
  • Equal number of age- and sex-matched nondiabetic patients will be taken as control group
  • Persons giving valid consent.

Exclusion criteria

  • Patients with systemic diseases and local ocular disease/surface abnormalities, as assessed by history and clinical examination, other than diabetes mellitus, which are known to cause dry eyes/ocular surface abnormalities (patients on antihistamines, antidepressants, oral contraceptives, and smokers)
  • Patients having phthisis bulbi in either eye
  • One-eyed patients
  • Patients who are chronic contact lens wearers
  • Patients who have had undergone ocular surgeries in the past
  • Patients on local or systemic medications, which are known to cause dry eyes/ocular surface disorders
  • Patients with ocular trauma
  • Patients with ocular allergies
  • Presence of punctal cautery or punctal plugs
  • Patients not consenting to study/not giving valid consent.

Ethical clearance

Ethical clearance was obtained from the Institutional Ethical Committee of JNMC, Sawangi (Meghe), Wardha, on 18th May 2019. With ethical clearance no DMIMS(DU)/IEC/2019-20/330.

  Discussion Top

  • Dry eye is a disease which has many predisposing factors. It is a common clinical condition which affects 5%–28% of adult population. There are around 3.23 M females and 1.68 M males over 50 years of age to have dry eye disease.[4] As such, there is no gold standard test for dry eye assessment. Hence, batteries of tests are used to help in dry eye diagnosis. There were seventy females and sixty males in the present study [Table 1]. The mean age of the cases taken in the study was 63.73 years and that of controls was 64.2 years [Table 2]. Of the 130 participants in the study, the majority of the patients were in the age group of 56–70 years. Both cases and controls together shared 101 patients among this age group [Table 3] and [Graph 1]
  • Forty-four cases in the study had their duration of diabetes between the duration of 0 and 5 years (16 among the age group of 6–10 years and 5 among the age group of 11–15 years). Most of the cases in the study were having a history of diabetes of duration <5 years. This accounts to about 67.69% of the cases in the study. Those patients who had a history of 6–10 years of having diabetes were 16 (24.16%) and the last group constituted 6.5% of the total cases [Table 3] and [Graph 2]
  • The tests done on patients were TBUT and Schirmer's test with and without anesthesia. They helped in the assessment of tear film stability and tear secretion measurement. Initially, TBUT test was performed, and 13 (20%) cases taken into the study were found to have a positive test result, while only 5 (7.69%) were having a positive test result in nondiabetic persons [Table 4]
  • In Schirmer's test without anesthesia, 15 (23.07%) patients showed a positive test result, while only 5 controls showed a positive test result [Table 5]
  • In Schirmer's test with anesthesia, the number of patients showing positive result was corresponding to those of Schirmer's test without anesthesia [Table 6]
  • The number of male cases and controls having positive test result in Schirmer's test without anesthesia, Schirmer's test with anesthesia, and TBUT remains same, i.e. 7 and 3, respectively. However in females, Schirmer's test without anesthesia and Schirmer's test with anesthesia showed similar results, i.e. 8 in cases and 2 in controls. TBUT showed less number of positive cases as compared to Schirmer's test, but in controls, their number remained the same. These results show that there were two female cases in whom the measurement of precorneal tear film was reduced but it was stable [Table 7] and [Graph 3]
  • On comparing positive test result with the duration of diabetes, it showed increase in the number of positive test result with increase in the duration of diabetes. In spite of having less number of cases who have duration of diabetes above 5 years' duration (32.31%), they contribute majority among patients showing positive test result. Only five patients showed a positive test result for Schirmer's test with and without anesthesia in 0–5 years' category; this number jumps up to 10 in patients having duration of >5 years. A similar trend was seen in TBUT test which showed that only two patients had unstable tear film under 0–5 years of duration, while this number was 11 in patients having duration of >5 years [Table 8] and [Graph 4]
  • In a study done by Sudha et al., there were 43% of males and 57% of females in the study. The mean age of the males was 50.13 years, and the mean age of the females was 50.27 years. In diabetics, 19% had dry eye, and in nondiabetics, 7% had dry eye
  • TBUT test was positive in 9% in nondiabetic and 19% in diabetic group. The Schirmer's test values were significantly lower in diabetics compared to nondiabetics[5]
  • In a study done by Yoon et al., 47 patients with diabetes mellitus and 30 normal controls were taken. TBUT and tear secretion were significantly reduced in the diabetic patients[6]
  • In a study done by Goebbel, diabetics showed decreased Schirmer's test readings[7]
  • A study by Igor Kaiserman et al. concluded that Keratoconjunctivitis sicca (KCS) is significantly more common among diabetic patients[8]
  • Studies by Manaviat et al. show that 54.3% of patients suffer from dry eye. There was a significant association between dry eye syndrome and duration of diabetes[9]
  • A study by Kesarwani et al. shows that when compared with the healthy controls, diabetics showed significantly reduced Schirmer's and TBUT measurements.[10],[11],[12],[13],[14],[15]
Table 1: Sex-wise distribution of cases and controls taken into the study

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Table 2: Mean age of cases and controls

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Table 3: Duration of diabetes and age in years

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Table 4: Positive test result of tear film break-up time test

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Table 5: Positive test result in Schirmer's test without anesthesia

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Table 6: Positive test result in Schirmer's test with anesthesia

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Table 7: Number of patients showing positive test result

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Table 8: Positive test result and duration of diabetes

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Financial support and sponsorship


Conflicts of interest

There are no conflicts of interest.

  References Top

Zeev MS, Miller DD, Latkany R. Diagnosis of dry eye disease and emerging technologies. Clin Ophthalmol Auckl NZ 2014;8:581-90.  Back to cited text no. 1
Comparison of the Schirmer I Test with and without Topical Anesthesia for Diagnosing Dry Eye. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3428545/. [Last accessed on 2019 Jun 14].  Back to cited text no. 2
TOS-0502-DEWS-noAds. Available from: https://www.tearfilm.org/dewsreport/pdfs/TOS-0502-DEWS-noAds.pdf. [Last accessed on 2019 Oct 01].  Back to cited text no. 3
Schaumberg DA, Dana R, Buring JE, Sullivan DA. Prevalence of dry eye disease among US men: Estimates from the physicians' health studies. Arch Ophthalmol 2009;127:763-8.  Back to cited text no. 4
Sudha R, Praveen Kumar KV. A clinical study of the pre-corneal tear film in diabetic and non-diabetic persons-a case control study. Indian J Clin Exp Ophthalmol 2018;4:401-5.  Back to cited text no. 5
Yoon KC, Im SK, Seo MS. Changes of tear film and ocular surface in diabetes mellitus. Korean J Ophthalmol 2004;18:168-74.  Back to cited text no. 6
Goebbels M. Tear secretion and tear film function in insulin dependent diabetics. Br J Ophthalmol 2000;84:19-21.  Back to cited text no. 7
Kaiserman I, Kaiserman N, Nakar S, Vinker S. Dry eye in diabetic patients. Am J Ophthalmol 2005;139:498-503.  Back to cited text no. 8
Manaviat MR, Rashidi M, Afkhami-Ardekani M, Shoja MR. Prevalence of dry eye syndrome and diabetic retinopathy in type 2 diabetic patients. BMC Ophthalmol 2008;8:10.  Back to cited text no. 9
Kesarwani D, Rizvi SWA, Khan AA, Amitava AK, Vasenwala SM, Siddiqui Z. Tear film and ocular surface dysfunction in diabetes mellitus in an Indian population. Indian J Ophthalmol 2017;65:301-4.  Back to cited text no. 10
[PUBMED]  [Full text]  
Jaiswal S, Banait S, Daigavane S. A Comparative Study on Peripapillary Retinal Nerve Fiber Layer Thickness in Patients with Iron-Deficiency Anemia to Normal Population. J Datta Meghe Inst Med Sci Univ 2018;13:9-11. Available from: https://doi.org/10.4103/jdmimsu.jdmimsu_82_17. [Last accessed on 2019 Jul 27].  Back to cited text no. 11
Rathi N, Taksande B, Kumar S. Nerve Conduction Studies of Peripheral Motor and Sensory Nerves in the Subjects with Prediabetes. J Endocrinol Metab 2019;9:147-50. Available from: https://doi.org/10.14740/jem602. [Last accessed on 2019 Jul 27].  Back to cited text no. 12
Bhinder HHPS, Kamble TK. The Study of Carotid Intima-Media Thickness in Prediabetes and Its Correlation with Cardiovascular Risk Factors. J Datta Meghe Inst Med Sci Univ 2018;13:79-82. Available from: https://doi.org/10.4103/jdmimsu.jdmimsu_58_18. [Last accessed on 2019 Jul 27].  Back to cited text no. 13
Walinjkar RS, Khadse S, Kumar S, Bawankule S, Acharya S. Platelet Indices as a Predictor of Microvascular Complications in Type 2 Diabetes. Indian J Endocrinol Metab 2019;23:206-10. Available from: https://doi.org/10.4103/ijem.IJEM-13-19. [Last accessed on 2019 Jul 27].  Back to cited text no. 14
Phadnis P, Kamble MA, Daigavane S, Tidke P, Gautam S. Prevalence and Risk Factors – Hemoglobin A1c, Serum Magnesium, Lipids, and Microalbuminuria for Diabetic Retinopathy: A Rural Hospital-Based Study. J Datta Meghe Inst Med Sci Univ 2017;12:121-32. Available from: https://doi.org/10.4103/jdmimsu.jdmimsu_59_17. [Last accessed on 2019 Jul 27].  Back to cited text no. 15


  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7], [Table 8]


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