Untitled Document

ORIGINAL ARTICLE

Year : 2021 |  Volume : 3 |  Issue : 2|  Page : 1-5


A clinical study on ocular surface dysfunction and tear film abnormalities in patients with diabetes mellitus
FarandeSamruddhi Diliprao1*, Lokesh H M2
1*Postgraduate Student, 2 Professor, Department of Ophthalmology, Sri Siddhartha Medical College, SSAHE Tumkur, Karnataka India

* Address for Correspondence:
Dr. FarandeSamruddhi Diliprao, 3rd year PG, Dept of Ophthalmology Sri Siddhartha Medical College, SSAHE Tumkur Karnataka India. Email: samruddhi1210@gmail.com

Abstract
Background: Diabetes is a leading cause of ocular morbidity which is progressive and preventable with early diagnosis and treatment. It is a one of the important cause of avoidable blindness in the developed as well as developing countries. Ocular complications of diabetes mellitus include diabetic retinopathy, papillopathy, cataract, glaucoma, and ocular surface disease. Among these, diabetic retinopathy and diabetic cataract are major complications of type 2 diabetes mellitus. In the progression of disease, duration of  type II diabetes mellitus , blood sugar control, already existing hypertension, dyslipidemia, nephropathy and also anemia play an important role. In type II diabetes mellitus patients, ocular surface disorderlike dry eye has been noticed recently.  Type 2 Diabetes and dry eye disorder has found  to have a noticeable effect on  patient's quality of life  which is proven in multiple studies. Objective:To compare the tear film changes and ocular surface dysfunction in type 2 diabetes mellitus patients with non -diabetic patients. Methodology: A cross sectional study was conducted in Department of Ophthalmology at a Tertiary Care centre in Tumkur.  A total of 60 study subjects with type 2 diabetes mellitus patients and 60 non diabetic patients coming to ophthalmology OPD were selected for the purpose of study by convenient sampling technique. Results: Age and gender was matched between diabetics and non diabetics, Among Diabetics mean Schirmer'sTest was 9.43 ± 3.41 mm and among non-diabetics mean Schirmer's Test was 14.20 ± 2.71 mm. There was significant decrease in Schirmer'sTest among diabetics as compared to non diabetics. Among Diabetics mean TBUT was 7.60 ± 2.63 Seconds and among non-diabetics was 10.67 ± 2.11 seconds. There was significant difference in TBUT between two groups. Conclusion: The study concluded that the decreased formation of tear film and the MGD findings with Conjunctival staining was found to be more among the diabetic study population than those neither who nor non diabetic. 
Keywords: Tear film, Ocular surface dysfunction, Diabetes mellitus

Introduction
Diabetes is a leading cause of ocular morbidity which is progressive and preventable with early diagnosis and treatment. It is one of the important causes of avoidable blindness in the developed as well as developing countries. Ocular complications of diabetes mellitus include diabetic retinopathy, papillopathy, cataract, glaucoma, and ocular surface disease. Among these, diabetic retinopathy and diabetic cataract are major complications of type II diabetes mellitus.  In the progression of disease, duration of diabetes, blood sugar control, already existing hypertension, dyslipidemia, nephropathy and also anemia play an important role. In type 2 diabetic patients, ocular surface disorders like dry eye syndrome has found out to have effect on patient's quality of life which is proven in multiple studies.[1,2]  This study was aimed at screening of patients with diabetes mellitus for dry eye syndrome in this particular area so as to provide them with early diagnosis and treatment for the same to avoid further complications.
Dry eye has been defined as a complex ocular surface and tear film disorder resulting in deficiency or abnormally excessive evaporation of tears. Interpalpebral ocular surface damage along with complaints like discomfort in eyes and also visual disturbance occurs.[3, 4]
Dry eye syndrome (DES), is a disorder with multifactorial etiology caused due to inflammation of lacrimal gland and surface of eyes, altered function of meibomian gland and neurotrophic deficiency. Patients having dry eye disease complaints of grittiness, burning sensation, foreign body sensation, photophobia, redness and blurred vision.[5,6] The micro-angiopathy, maculopathy and autonomic neuropathy in long term diabetics can lead to absence of these symptoms but presents with clinical signs of dry eye as suggested by Nielsen et al.[7]
According to Tear film ocular society (TFOS) dry eye workshop 2 (DEWS) which was held in 2017, dry eye was termed as an ocular surface disease with variable etiology with characteristics of tear film homeostasis loss, plus ocular pathologycaused due to instability and hyperosmolarity of tear film, inflammation of ocular surface and neurosensory abnormalities[8] found to be contributory factors in 3 etiologies. Dry eye can be classified into 2 catagories as tear-deficient and evaporative.[9]
The tear film is made up of three layers, outer lipid layer (majorly by secretions of Meibomian glands), middle aqueous layer (the lacrimal gland secretions) and lastly inner mucin layer (goblet cells of conjunctiva). The cornea, conjunctiva and also the meibomian gland, lacrimal gland, lids, alongwith the sensory as well as motor nerves connecting them make the ocular surface.[9] The purpose of this study was to compare the tear film changes and ocular surface dysfunction in type 2 diabetes mellitus patients with non-diabetic patients.
Materials and methods
A cross sectional study was performedin Department of Ophthalmology at a Tertiary Care centre in Tumkur from October  2019 to October 2021. A total of 30 study subjects with type II diabetes mellitus patients and 30 non-diabetic patients coming to ophthalmology OPD were selected for the purpose of study by convenient sampling technique. 
Inclusion criteria
Type 2 DM patients of both the gender with more than 18 years of age, and duration between 5 to 10 years of DM, who have given consent to participate in the study was the inclusion study population in the study.
Exclusion criteria
Not given consent, history of ocular surgery, contact lens wearers, patients on topical treatment that found to cause or worsen dry eye like…., cases who are on systemic or local drugs such as oral contraceptives, antidepressants, antihistamines, diuretics, which are associated with causation of dry eye, cases with systemic diseases such as rheumatoid arthritis, Sjogren's syndrome, Parkinson's disease, and systemic lupus erythematosus and other ocular surface disorders associated with dry eye,  smokers, cases with vitamin A deficiency, patients having pseudo exfoliation syndrome, pregnant women and patients with a history of cranial nerve injury oractive ocular inflammation or infection.
The study participants were asked regarding subjective symptoms, dry eye severity scale score was calculated and recorded, and all were subjected to ophthalmologic examination, which includes detailed ocular surface examination using slit lamp to look for the eyelids, condition of meibomian gland, pre-corneal tear film, conjunctival, and corneal surface was evaluated using fluorescein stain.
Tear film assessment was done as follows:

  • Lid margin alterations were recorded: irregularity of the margins, vascular dilatation, the mucocutaneous junction position, whether any obstructed orifices of Meibomian glands noted
  • Pre-corneal tear film - for debris
  • Tears break-up time (TBUT) test carried out
  • Schirmer's test (SchT) test done
  • Corneal staining
  • Conjunctival staining

Statistical analysis
Data was feeded into Microsoft excel data sheet and was analyzed with SPSS 22 version software. Categorical data  representation was done in the form of frequencies and proportions. For this study,  qualitative data analysis was done, the test of significance was Chi-square test. Mean and standard deviation was used to show continuous data .The test of significance to find out the mean difference between two quantitative variables was Independent t test.
To get different types of graphs and tables, MS excel and MS Word were used
After considering all the rules of statistical tests p value (Probability- result is true) of less than 0.05 had been considered as statistically significant.

Results
Table 1: Profile of subjects in the study

 

group

Chi-square

df (Degree of Freedom)

P value

Diabetics

Non-Diabetics

Count

%

Count

%

Age

41 to 50 years

14

23.3%

18

30.0%

5.433

2

0.066

51 to 60 years

20

33.3%

28

46.7%

>60 years

26

43.3%

14

23.3%

Mean ± SD

59.57 ± 9.35SD

55.70 ± 8.88SD

t value
-2.322

118

0.022*

Gender

Female

24

40.0%

26

43.3%

0.137

1

0.711

Male

36

60.0%

34

56.7%

Among Diabetics, most of subjects found to be in the age group >60 years (43.3%) and in Non Diabetics, maximum number of subjects were in the age in years of 51 to 60 (46.7%). There wasn't a significant difference in distribution of agein two groups.
In Diabetics, 60% were male patients and 40% female patients and in non-diabetics, 56.7% males and 43.3% females were there. There wasn't any significant difference in the distribution of gender between two groups.
Table 2: Schirmer's Test and TBUT comparison between Diabetics and Non-Diabetics

 

Schirmer'sTest in mm

TBUT in seconds

Mean

SD

Mean

SD

Group

Diabetics

9.43±3.38SD

7.60±2.61SD

Non-Diabetics

14.20±2.68SD

10.67±2.088SD

 

t value

8.550

7.104

 

df (Degree of Freedom)

118

118

 

P value

<0.001*

<0.001*

Among Diabetics mean Schirmer's Test was 9.43±3.38 SD mm and among non-diabetics mean Schirmer's Test was 14.20±2.68 SD. There was significant decrease in Schirmer's Test among diabetics compared to non diabetics. Among diabetics mean TBUT was 7.60±2.61SD seconds and among non-diabetics was 10.67±2.088 SD seconds. There was significant difference in TBUT between two groups.


Table 3: Ocular Examination Findings comparison between Diabetics and Non-Diabetics

 

Group

Chi-square

df (Degree of Freedom )

P value

Diabetics

Non-Diabetics

Count

%

Count

%

MGD

Not Present

26

43.3%

52

86.7%

24.762

1

<0.001*

Present

34

56.7%

8

13.3%

Tear film debris

No

52

86.7%

56

93.3%

1.481

1

0.224

Yes

8

13.3%

4

6.7%

Conjunctival Staining

No

28

46.7%

56

93.3%

31.111

1

<0.001*

Yes

32

53.3%

4

6.7%

Corneal staining

No

50

83.3%

58

96.7%

5.926

1

0.015*

Yes

10

16.7%

2

3.3%

Foreign body sensation

No

26

43.3%

48

80.0%

17.062

1

<0.001*

Yes

34

56.7%

12

20.0%

In the study among diabetics, 56.7% had MGD, 13.3% had tear film debris, 53.3% had conjunctival staining, 16.7% had corneal staining and 56.7% had foreign body sensation. Among non-diabetics, 13.3% had MGD, 6.7% had tear film debris, 6.7% had conjunctival staining, 3.3% had corneal staining and 20% had foreign body sensation.
Discussion
 In the present study we found that the mean age for the study subjects was 55.70 years among diabetic group and 59.57 years among the non diabetic study group with insignificant p value. It was also found that majority of the study participants were aged more than 60 years in diabetic group when compared to non diabetic group. However age was matched between two groups. Hence it could be easily analyzed that among the diabetic people, the tear film abnormalities presented at early age as compared to non diabetic study population. The findings of the study were found to be similar comparable to the study findings of Divya K et al9 and Ozdemir M et al.[10]
The gender predominance of the study population wasn't statistically significant between the 2 groups with male predominance seen in each of the study and control group. The association of gender between diabetic group and non diabetic group in our study was found to be comparable to the study findings of Divya K et al[9] and Manjula T R et al.[11]
The Schirmer'stest is considered to be one of the simplest, fastest and cost effective test which can be used as a diagnostic test to assess the tear film production capacity of the eyes. In this present study schirmer's test values were for very less among the diabetic patients group as compared to non diabetic study group.  Tear secretion was found out to be decreased in the those who had diabetes when compared with non diabetic in the present study. Schirmer's test was found to be having a value of 9.95+ 4.56 among diabetic and 25.84+ 7.32 among non-diabetic subjects and the association was found to be statistically significant in a study performed by Divya K et al which was comparable to our study findings. In another study done by Ozdemir M et al[10] schemer test was 8.75+0.24 in diabetic and 16.67+2.41 among control with significant p value which was similar to our study findings. In another studies done by GoebbbelsM et al12 and Yoon K C et al[13] also found that results of schirmers's test were similar to our study. Whereas in the study conducted by Li et al[14], findings contrasting to this study findings where both diabetic and non diabetic had same values of schirmers's test were found and the p value was also non-significant.
On evaluating the eye function on tear production by TBUT test it also showed that the value of Mean TBUT test was seen to be more in non-diabetics ascompared with diabetic group having significant p value in ourstudy. In the study of Divya K et al[9], ozdemir M et al[10], yoon K C et al[13] and Li HY et al[14] found values of TBUT test between diabetic and non diabetic test similar to our study findings, whereas Goebbels M et al[12] found contrasting results to our study findings.
The ocular examination found that MGD and Conjunctival staining was found to be statistically significant between both the groups whereas as other findings like tear film debris, corneal staining, and foreign body sensation was found to be statistically insignificant. Our study findings were found same as the study results of Manjula T R et al[11] and Shamsheer R P et al[15] and Lemp M A et al[16].
Conclusion
Finally, from our study we could conclude that the decreased formation of tear film and the MGD as well as conjunctival staining was found to be more among the diabetic study population than non diabetic study population.  Because of decreased tear production and increased incidence of having the dry eye among diabetic the chances of having ocular problems both functional and physical injuries in the eye happens more and presents with complications.
Long term diabetes predisposes to changes in tear film causing ocular surface irregularities which leads to dry eye. Early identification of symptoms, signs and timely evaluation by the treating ophthalmologist, must be given priority in the analysis for dry eye in diabetic patients.
Limitation of the study:
Screening was done or restricted for the 120 patients, half of them i.e. 60 patients were diabetic and 60 were controls because of non avaibility of patientsas the OPD wa closed due to covid pandemic for around an year of the total study period.
Acknowledgement: Nil
Financial support and sponsorship: Nil
Conflict of interest: Nil
References
1.   Harrison TR: Diabetes Mellitus. In Harrison Principle of Internal Medicine 15th limited edition. Edited by: Branwald E, Fauci S, Kasper D, USA, Mc Grow-Hill; 2001:2121
2.   Saini JS, Khandalavla B. Corneal epithelial fragility in diabetes mellitus. Can J Ophthalmol 1995; 30:142-6.
3.   Jain S: Dry Eyes in Diabetics. Diabetes Care 1998,21(8):1364- 1382.
4.   Dogru M, Katakami C, Inoue M. Tear function and ocular surface changes in noninsulin-dependent diabetes mellitus. Ophthalmology 2001; 108:586-92.
5.   Inoue K, Kato S, Ohara C, Numaga J, Amano S, Oshika T. Ocular and systemic factors relevant to diabetic keratoepitheliopathy. Cornea 2001; 20:798‑801.
6.   Report of the National Eye Institute/Industry workshop on Clinical Trials in Dry Eyes. Lemp MA CLAO J. 1995 Oct; 21(4):221-32.
7.   Nielsen NV, Lund FS. Diabetic polyneuropathy, corneal sensitivity, vibratory perception and Achilles tendon reflex in diabetes. ActaNeurologicaScadinavica 1979, 59:15–22.
8.   Dews TFOS DEWS II Definition and Classification Report, Jennifer P. Craig, Kelly K. Nichols, Esen K. Akpek, Barbara Caffery, Harminder S. Dua, Choun-Ki Joo, Zuguo Liu, J. Daniel Nelson, Jason J. Nichols, Kazuo Tsubota, Fiona Stapleton, The Ocular Surface 15 (2017) 276e283.
9.   Kesarwani D, Rizvi SW, 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.
10. M. Ozdemir, M.A. Buyukbese, A. Cetinkaya, G. Ozdemir. Risk factors for ocular surface disorders in patients with diabetes mellitus. Diabetes Research and Clinical Practice.2003; 59:195-199
11. Manjula TR, Gahana K, Harsha R. A Clinical Study on Meibomian Gland Dysfunction and Dry Eye in Patients with Type 2 Diabetes Mellitus. J Med Sci Health 2019;5(3):7-12
12. Goebbels M. Tear secretion and tear film function in insulin dependent diabetics. Br J Ophthalmol 2000; 84:19‑21
13. Yoon KC, Im SK, Seo MS. Changes of tear film and ocular surface in diabetes mellitus. Korean J Ophthalmol 2004; 18:168‑74
14. Li HY, Pang GX, Xu ZZ. Tear film function of patients with type 2 diabetes. Zhongguo Yi XueKeXue Yuan XueBao 2004; 26:682‑6.
15. Shamsheer RP, Arunachalam C. A clinical study of meibomian gland dysfunction in patients with diabetes. Middle East Afr J Ophthalmol 2015; 22:462-6.
16. Lemp MA. Report of the national eye institute/industry workshop on clinical trials in dry eyes.CLAO J 1995; 21:221-32.


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