|Year : 2020 | Volume
| Issue : 2 | Page : 69-73
A prospective clinical study of the incidence of dry eye disease, following manual small incision cataract surgery, in a suburban population of South India
Mamleshwari Patil, Venkatesh Sugantharaj, Shruti Hegde
Department of Ophthalmology, Shri Sathya Sai Medical College and Research Institute, Chengalpet, Tamil Nadu, India
|Date of Submission||11-Feb-2020|
|Date of Decision||21-Apr-2020|
|Date of Acceptance||01-May-2020|
|Date of Web Publication||17-Jun-2020|
Dr. Venkatesh Sugantharaj
Department of Ophthalmology, Shri Sathya Sai Medical College and Research Institute, Ammapettai, Nellikuppam, Kancheepuram, Chengalpet - 603 108, Tamil Nadu
Source of Support: None, Conflict of Interest: None
Aim: The aim of this study is to evaluate, assess and grade the severity of dry eye disease following manual small incision cataract surgery (MSICS). Background: Any phenomenon which disturbs the ocular surface directly or indirectly leads to the beginning of ocular surface disease and dry eye syndrome. Ophthalmic surgeries, especially cataract surgery is one of the factors which causes dysfunction of the Lacrimal Functional Unit and may lead to dry eye disease. MSICS is the surgery of choice in the majority of the rural and suburban sector of India. Many patients undergoing MSICS complains of dry eye symptoms in their postoperative follow-up period. Materials and Methods: This was a prospective, hospital-based, longitudinal study consisting of 100 patients, conducted in a tertiary health care hospital over a period of 18 months, from November 2017 to May 2019, after obtaining ethical committee approval. Patients undergoing MSICS were evaluated for dry eyes using ocular surface disease index questionnaire, schirmer's-1 test (without anesthesia), tear film break-up time test, and oxford system of ocular surface staining, preoperatively and postoperatively on three follow up visits on days 7, 21 and 45 respectively. Results: Overall incidence of dry eye disease was 69%. The severity of dry eye disease was mild in 13%, moderate in 33% and severe in 23% of patients. The incidence of dry eye disease was more in higher in the elderly age group following surgery (mean age 61 ± 11 years, P < 0.05). Conclusion: The study found a higher incidence of dry eye disease following MSICS. The sign and symptoms were most profound around first week postoperatively and then regressed overtime, suggesting its self-limiting course. Majority of patients had moderate dry eye disease and also elderly patients being affected more frequently.
Keywords: Dry eye disease, manual small incision cataract surgery, postoperative dry eyes
|How to cite this article:|
Patil M, Sugantharaj V, Hegde S. A prospective clinical study of the incidence of dry eye disease, following manual small incision cataract surgery, in a suburban population of South India. TNOA J Ophthalmic Sci Res 2020;58:69-73
|How to cite this URL:|
Patil M, Sugantharaj V, Hegde S. A prospective clinical study of the incidence of dry eye disease, following manual small incision cataract surgery, in a suburban population of South India. TNOA J Ophthalmic Sci Res [serial online] 2020 [cited 2020 Jul 13];58:69-73. Available from: http://www.tnoajosr.com/text.asp?2020/58/2/69/286943
| Introduction|| |
Cataract surgery is the most common intraocular surgery performed worldwide. Manual small incision cataract surgery (MSICS) continues to be the surgery of choice, for handling the large volume of cataract patients in developing countries like India and especially in its rural and suburban sections. Patients reporting for postoperative follow-up visits after MSICS commonly complains of dry eye-related symptoms. It is well known that dry eye is a multifactorial disease and there may be several causes behind the pathogenesis of dry eye disease.
Cataract surgeries, especially MSICS is an important reason for dry eye disease. There are multiple factors which have been proposed for the development of dry eye disease following MSICS. These are disruption of the lacrimal functional unit,,,, severance of the corneal nerves during the surgical incision,,,, inflammation of the corneal nerves and ocular surface due to surgical trauma,, prolonged use of postoperative topical medications especially eye drops containing preservatives,,,,,, tear film instability due to Meibomian gland More Details dysfunction,,,,,, thinning of lipid layer, reduced goblet cell density, and prolonged exposure to the operating microscope light.,, There has been a significant load on the ophthalmologists by the dry eye-related complaints following cataract surgery. Therefore, there is need of more research to be done in this area. This study was conducted evaluate the dry eye disease following MSICS as well as to assess its severity which will be helpful in early diagnosis and treatment of the disease and also to ensure long-term patient satisfaction following cataract surgery.
| Materials and Methods|| |
This was a hospital-based, prospective study performed at a tertiary health-care institution and hospital in the department of ophthalmology over 18 months period from November 2017 to May 2019, after obtaining Institutional Ethical Committee approval.
A total of 110 patients were included out of which 10 patients were lost to follow-up. Hence, the study analysis was done on 100 patients.
The sample size was calculated based on a similar study done in south India using the formula, n = 4Pq/L2, WhereP= prevalence of dry eye disease in patients following surgery, q = 100 − P, L = allowable error, P= 66.2, q = 33.80, L = 15% of P, i.e. 9.93, n = 4 × 66.2 × 33.80/(9.93)2, n = 91 considering non-responsive error to be 20%, n = 110.
Patients above 40 years of age, diagnosed with operable cataracts and who underwent MSICS were included in the study. Patients having pre-existing dry eye disease, acute ocular infections, ocular allergies, pterygia, giving a history of undergoing ocular surgery within 6 months of enrollment, presence of active systemic illnesses such as diabetes mellitus which can predispose to dry eye disease, as well as those using systemic medications known to cause dry eye disease and patients having a history of contact lens wear, were excluded from the study.
A written informed consent in patient's own language was obtained. After obtaining a detailed history, a thorough preoperative examination was performed. In addition to this, specific tests to rule out pre-existing dry eye disease were done, details of which are given later. Patients then underwent MSICS. Follow-up visits and evaluation were done on 7th (1st week), 21st (3rd week), and 45th (6 weeks) postoperative days. The details of diagnostic tests done for dry eye evaluation are as follows:
- Ocular surface disease index questionnaire (OSDI): A symptom-based validated questionnaire based on which subjective assessment of the severity of dry eye was made, and further classified as normal, mild, moderate, and severe dry eyes.
- Schirmer's-I test without using topical anesthetic: was performed to assess the basal and reflex tear secretion. The test was done using a Whatman No. 41 filter paper (5 mm × 35 mm). The length of paper moistened was noted in millimeters at the end of 5 min.
- Tear film break-up time test (TBUT): was performed to note the interval between the last blink and the appearance of a randomly distributed dry spot on the cornea. Dry spots that repeatedly occur at the same location were ignored. This observation was carried out after staining the tear film using a fluorescein impregnated strip and the time was noted in seconds. The mean TBUT value was taken as the final reading after repeating the procedure 2–3 times.
- Oxford system of ocular surface staining: done using a fluorescein impregnated strip moistened with saline or antibiotic eye drop, placed onto tarsal conjunctiva. The grading of staining for cornea and conjunctiva is done under slit lamp using the Oxford grading schema.
Statistical analysis of data was done by using SPSS (IBM SPSS Statistics for Windows, Version 23.0. Armonk, NY: IBM Corp.). Correlation of data between the study variables was done by analysis of variance and the student's t-test. The level of significance was taken 5% and confidence interval was 95%.
| Results|| |
In this study, of 100 patients, 52 patients underwent MSICS for right eye and 48 for left eye. Age of the patients ranged from 40 to 96 years, details of which are shown in [Table 1]. The mean age of the patients was 61.77 ± 11.01 years. Among the patients who belonged to the elderly age group (>60 years), incidence of dry eyes was more common and was statistically significant (P = 0.008). The gender distribution of the population was 44 male and 56 female patients out of which 31 male patients and 38 female patients developed dry eye disease. Although the incidence was slightly higher in females in comparison to males, this was due to a higher population of female patients in the study and was not found to be statistically significant (P = 0.589).
Incidence of dry eye in postoperative period
The presence of dry eye in 2 or more tests out of the 4 tests used, during one or more follow-up visits was considered as the diagnostic measure of postoperative dry eye disease in patients included in the study.
Out of 100 patients included in the study 69 (69%) had dry eye at one or more follow-up visits. Among these, 13% developed mild, 33% had moderate, and 23% were found to have severe dry eyes, according to OSDI scoring.
OSDI scores significantly increased from preoperative to postoperative visits and the mean comparison was found to be statistically significant (P < 0.001). The correlation of OSDI scores with dry eyes is illustrated in [Figure 1]. The peak of the OSDI scores were found to occur at postoperative day 7 (21.9). The OSDI scores showing maximum dryness at 1 week follow-up and improved in the successive follow-up visits as shown in [Table 2].
|Figure 1: Correlation of ocular surface disease index questionnaire scores with dry eye|
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|Table 2: Mean ocular surface disease index questionnaire scores during follow-up visits|
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Schirmer's test-1 (without anesthesia) values significantly reduced from preoperative to postoperative values and the mean comparison was found to be statistically significant (P < 0.001). The lowest value was noted on first follow-up visit as shown in [Table 3].
TBUT values were also significantly decreased from preoperative to postoperative visits and were found to be lowest on the 7th postoperative day, showing maximum dryness as shown in [Table 4].
|Table 4: Mean tear film break-up time test values and their correlation with dry eye|
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Corneal and conjunctival grading of staining by oxford schema: The distribution of grading of staining during follow-up visits is illustrated in [Figure 2]. The pattern showed maximum staining on first postoperative visit (1st week), which was statistically significant and there was improvement in next follow-up visits. This is given in [Table 5].
| Discussion|| |
Dry eye-related symptoms are very commonly complained by patients undergoing cataract surgery, during the immediate postoperative follow-up period. In this study, we assessed and graded dry eye disease following MSICS.
The mean age in our study was 61.77 ± 11.01 years which is comparable to the study done by Jayshree et al. in which the mean age was 58.18 ± 8.62 years. There was a statistically significant correlation between age (<60 years) and the occurrence of dry eye. This higher incidence could be related to borderline or subclinical dysfunction of tear film in this age group which is further compromised following cataract surgery. A higher incidence of dry eyes and its association with advancing age has been reported in the Beaver dam eye study.
The association between female gender and dry eye has been well established.,,, However, we did not find a statistically significant correlation in our study between female gender and dry eyes.
Our study showed a high incidence of dry eye disease following MSICS (69%). The definitive diagnosis of dry eye is further challenged by the absence of a specific confirmatory test for the same. Thus, we have taken positive results in any 2 of the 4 commonly performed clinical methods as the diagnostic measure of postoperative dry eye. Our finding is in accordance with many of the previously done studies which evaluated dry eye following MSICS, which also showed high incidence.,
Majority of our patients had moderate dry eye (33% according to OSDI scores). Many studies done in the past showed mild grade dry eye to be the most common.,,, One study in the past which showed a very high incidence of postoperative dry eye (96.6%), however, depicted severe grade dry eye to be the most common.
The preoperative and postoperative OSDI questionnaire values were significantly altered with a high statistical significance. The maximum OSDI values were found in the first postoperative visit, and a similar finding was seen in the study by Kasetsuwan et al.
The mean Schirmer's-1 test (without anesthesia) values also showed statistically significant change in the pre and postoperative values with the least values in the first postoperative visit. Similar findings were found in the study done by Jayshree et al.
The mean TBUT value was also reduced post operatively with a statistically significant difference. The reduction was, like the other two tests found to be the most during the first postoperative visit. TBUT was also found reduced in earlier studies.,
Oxford system of ocular surface staining also showed statistically significant change in mean of corneal and conjunctival grading values, the highest of which were on 7th postoperative day and declined toward next follow-up visits. This finding was in agreement with the study performed by Miyake and Yokoi.
The incidence and severity of dry eyes were found to be maximum during the first visit and gradually reduced with the passage of time. All our test results were found to be in agreement with this. A previous study done in northern part of India also had similar results as our study. The reasons for this could be multifactorial. Firstly, the transection of corneal nerves which occurs while constructing the corneoscleral tunnel and which also tends to heal with the passage of time. Secondly, the ocular trauma induced by the surgery in the form of cutting the conjunctiva, incising the sclera and fixation with toothed forceps of the limbus causing the release of inflammatory mediators that can precipitate and potentiate the occurrence of dry eye. These inflammatory mediators tend to subside over time. Thirdly, topical medications like steroids with inherent preservatives are used at a much higher dosage in the first week of surgery and tapered over the following weeks. The strength of this study is in the structure of the study where we performed all the diagnostic tests, preoperatively and postoperatively during the follow-up visits, which is useful for the comparison of the changes in the test values preoperatively and postoperatively as well as gaining more knowledge about the postoperative course of the disease. This approach will prove useful in expanding our understanding of dry eye disease, the symptoms of which are the frequent complaints in the postoperative period by patients who underwent MSICS. Our study had limitations in the form a small sample size. Furthermore, the last follow-up visit was at 6 weeks. A longer follow-up period of 3 months would have added more insight into the behavior of postoperative dry eyes. Further, adding impression cytology, which is a more sensitive and specific test, would have increased the validity of our findings. We would also like to conduct a study comparing the incidence of dry eye between MSICS and phacoemulsification in the future.
| Conclusion|| |
The large volume of cataract backlogs that exist requires a major intervention in the form of cataract surgeries, and in a suburban and rural population, MSICS is the most commonly performed cataract procedure.
A significant proportion of patients undergoing cataract surgery go on to develop dry eye symptoms due to a variety of factors, either induced by the surgery itself or due to concurrent postoperative medications. The encouraging observation is that dry eye symptoms become lesser over time and in many patients, it's probably just a transient discomfort following cataract surgery. We therefore recommend that artificial tear substitutes could be prescribed in the immediate postoperative period to lessen the symptoms of dry eyes and also to reassure the patients that the discomforting symptoms of dry eyes will improve with the passage of time.
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Conflicts of interest
There are no conflicts of interest.
| References|| |
Davis G. The evolution of cataract surgery. Mo Med 2016;113:58-62.
Karve S, Rathi H, Kolte A. Manual small incision cataract surgery: A suitable option for resource-poor settings. 2018;5:D1-D4. doi: 10.21276/ijcmr.2018.5.4.41.
Craig JP, Nichols KK, Akpek EK, Caffery B, Dua HS, Joo CK, et al
. TFOS DEWS II definition and classification report. Ocul Surf 2017;15:276-83.
Ishrat S, Nema N, Chandravanshi SC. Incidence and pattern of dry eye after cataract surgery. Saudi J Ophthalmol 2019;33:34-40.
Kanski JJ. Retinal detachment. In: Clinical Ophthalmology. 7th
ed. London: Elsevier; 2011. p. 687-733.
Pflugfelder SC, Solomon A, Stern ME. The diagnosis and management of dry eye: A twenty-five-year review. Cornea 2000;19:644-9.
Lemp MA, Foulks GN. The definition and classification of dry eye disease. Ocul Surf 2007;5:75-92.
Stern ME, Gao J, Siemasko KF, Beuerman RW, Pflugfelder SC. The role of the lacrimal functional unit in the pathophysiology of dry eye. Exp Eye Res 2004;78:409-16.
Cho YK, Kim MS. Dry eye after cataract surgery and associated intraoperative risk factors. Korean J Ophthalmol 2009;23:65-73.
Kohlhaas M. Corneal sensation after cataract and refractive surgery. J Cataract Refract Surg 1998;24:1399-409.
Sutu C, Fukuoka H, Afshari NA. Mechanisms and management of dry eye in cataract surgery patients. Curr Opin Ophthalmol 2016;27:24-30.
Venugopal KC, Krishnaraj PA, Chandan N. Evaluation of dryness of eyes after manual small incision cataract surgery with corneoscleral tunnel incision. J Clin Diagn Res 2012;6:1029-33.
Chee SP, Ti SE, Sivakumar M, Tan DT. Postoperative inflammation: Extracapsular cataract extraction versus phacoemulsification. J Cataract Refract Surg 1999;25:1280-5.
Kusano M, Uematsu M, Kumagami T, Sasaki H, Kitaoka T. Evaluation of acute corneal barrier change induced by topically applied preservatives using corneal transepithelial electric resistance in vivo
. Cornea 2010;29:80-5.
Kawahara A, Utsunomiya T, Kato Y, Takayanagi Y. Comparison of effect of nepafenac and diclofenac ophthalmic solutions on cornea, tear film, and ocular surface after cataract surgery: The results of a randomized trial. Clin Ophthalmol 2016;10:385-91.
Lee JS, Kim YH, Park YM. The toxicity of nonsteroidal anti-inflammatory eye drops against human corneal epithelial cells in vitro
. J Korean Med Sci 2015;30:1856-64.
Li XM, Hu L, Hu J, Wang W. Investigation of dry eye disease and analysis of the pathogenic factors in patients after cataract surgery. Cornea 2007;26:S16-20.
Kato K, Miyake K, Kondo N, Asano S, Takeda J, Takahashi A, et al
. Conjunctival goblet cell density following cataract surgery with diclofenac versus diclofenac and rebamipide: A randomized trial. Am J Ophthalmol 2017;181:26-36.
Congdon NG, Schein OD, von Kulajta P, Lubomski LH, Gilbert D, Katz J. Corneal complications associated with topical ophthalmic use of nonsteroidal antiinflammatory drugs. J Cataract Refract Surg 2001;27:622-31.
Baveja A, Batra N. A comparative study of tear film parameters before and after small incision cataract surgery and phacoemulsification. J Evid Based Med 2017;4:1510-3.
Jayshree MP, Shivkumar H, Monalisha P, Mallikarjun S. A prospective study of dry eye after manual small incision cataract surgery in rural population of Bagalkot. J Clin Res Ophthalmol 2017;4:25-9.
Movahedan A, Djalilian AR. Cataract surgery in the face of ocular surface disease. Curr Opin Ophthalmol 2012;23:68-72.
Park Y, Hwang HB, Kim HS. Observation of influence of cataract surgery on the ocular surface. PLoS One 2016;11:e0152460.
Bron AJ, Tiffany JM. The contribution of meibomian disease to dry eye. Ocul Surf 2004;2:149-65.
Han KE, Yoon SC, Ahn JM, Nam SM, Stulting RD, Kim EK, et al
. Evaluation of dry eye and meibomian gland dysfunction after cataract surgery. Am J Ophthalmol 2014;157:1144-500.
Kim JS, Lee H, Choi S, Kim EK, Seo KY, Kim TI. Assessment of the tear film lipid layer thickness after cataract surgery. Semin Ophthalmol 2018;33:231-6.
Oh T, Jung Y, Chang D, Kim J, Kim H. Changes in the tear film and ocular surface after cataract surgery. Jpn J Ophthalmol 2012;56:113-8.
Ipek T, Hanga MP, Hartwig A, Wolffsohn J, O'Donnell C. Dry eye following cataract surgery: The effect of light exposure using an in-vitro
model. Cont Lens Anterior Eye 2018;41:128-31.
Moss SE, Klein R, Klein BE. Incidence of dry eye in an older population. Arch Ophthalmol 2004;122:369-73.
Doughty MJ, Fonn D, Richter D, Simpson T, Caffery B, Gordon K. A patient questionnaire approach to estimating the prevalence of dry eye symptoms in patients presenting to optometric practices across Canada. Optom Vis Sci 1997;74:624-31.
Moore CP. Qualitative tear film disease. Vet Clin North Am Small Anim Pract 1990;20:565-81.
Kasetsuwan N, Satitpitakul V, Changul T, Jariyakosol S. Incidence and pattern of dry eye after cataract surgery. PLoS One 2013;8:e78657.
Lakshmi PS, Sandhya CS, Jagannath C, Madhavi K. Changes in the tear film after manual small incision cataract surgery – A prospective study. Official Sci J Delhi Ophthalmol Soc 2018;29:26-30.
Miyake K, Yokoi N. Influence on ocular surface after cataract surgery and effect of topical diquafosol on postoperative dry eye: A multicenter prospective randomized study. Clin Ophthalmol 2017;11:529-40.
Sinha M, Sinha A, Chowdhury B. Comparative evaluation of dry eye following cataract surgery: A study from North India. IOSR J Dent Med Sci 2014;13:13-8.
[Figure 1], [Figure 2]
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5]