Abstract
Purpose:
Foreign body sensation and irritation are common after cataract surgery, as is the exacerbation of dry eye disease if present. This study compared postoperative dry eye treatments and patient satisfaction.
Methods:
Age-related cataract patients undergoing phacoemulsification were recruited and were divided randomly into 4 postoperative treatment groups: Group A: Antibiotic + Steroids; Group B: Antibiotic + Steroids + Mydriatic; Group C: Antibiotic + Steroids + Mydriatic + Non-steroidal Ant-inflammatory drugs (NSAIDs); Group D: Antibiotic + Steroids + Mydriatic + NSAID + Tear substitute. Patients were assessed at 1, 3, and 5 weeks post-operatively for uncorrected distance and near vision, best corrected visual acuity (BCVA) for distance and near, Schirmer’s-1 test, and Tear Film Break-Up Time test. At each visit, patients were assessed for dry eye-related subjective parameters using Ocular Surface Disease Index questionnaire.
Results:
Study participants numbered 163. (87 male and 76 female patients). No statistically significant difference was present in visual acuity for near and distance. The mean values of Schirmer’s test and TFBUT were better in group D patients at each postoperative visit, with significant differences noted in comparison with other groups. The patient response to pain and dry eye symptoms was superior in groups C and D, with group D producing the best results. Compared to group A, patients in groups C and D were more satisfied with their vision and surgery.
Conclusion:
The addition of tear substitutes to steroids and NSAIDs has been associated with decreased dry eye-related symptoms and a better subjective feeling of vision, although no significant difference was noted in vision measured objectively.
Keywords: Dry eye, phacoemulsification, postcataract surgery patient satisfaction, postphacoemulsification treatment regimens
In India, cataract surgery is one of the most frequently performed elective surgeries. Dry eye symptoms, such as foreign body (FB) sensation and irritation, are frequently observed following cataract surgery, along with the exacerbation of dry eye disease, if present. Diverse multiple postcataract surgery regimens are used by practitioners all over the world, but there is no consensus on the optimal and most effective treatment. This study was conducted to compare the effects of commonly used postoperative treatment protocols on dry eye symptoms and patient satisfaction following cataract surgery.
Methods
A prospective interventional study was conducted at a tertiary eye care center over a period of 10 months after approval of the institutional ethics committee. Patients with age-related cataract, without any other ocular comorbidities undergoing phacoemulsification surgery, were recruited for participation in the study after written informed consent. All surgeries were performed under peribulbar anesthesia. Patients having intraoperative complications were excluded from the study. After appropriate sample size calculation, a total of 163 patients were recruited for the study. They were randomly allocated by use of a random number table into four groups based on postoperative treatment regimens [Table 1].
Table 1.
Various postoperative treatment regimens
| Group A |
| Steroid - Antibiotic fixed dose combination eye drops (Tobramycin 0.3% and dexamethasone 0.1%) starting at 6 times/day and taper to 2 times/week over 5 weeks |
| Group B |
| Steroid - Antibiotic combination as in Group A Mydriatic - Tropicamide 1% eye drop HS for 1 week |
| Group C |
| Topical medications as in Group B NSAID - Nepafenac 0.1% eye drop 3 times/day for 6 weeks |
| Group D |
| Topical medications as in Group C Artificial tear substitute - Carboxy methyl cellulose (CMC) 0.5% eye drop 4 times/day for 6 weeks |
Patients were followed up postoperatively at 1 week, 3 week, and 5 week postoperatively and assessed for various objective and subjective parameters. Objective parameters include uncorrected distance vision (logMAR by Snellen’s visual acuity chart), uncorrected near vision (by Jaeger’s near vision chart), best-corrected visual acuity (BCVA) for distance and near, Schirmer’s-1 test, Tear Film Break-Up Time (TFBUT) test. At 3 week postoperative visit, patients were assessed for refraction and were prescribed glasses. At each visit, patients were assessed for subjective parameters by use of specific symptom-related questionnaires derived from standardized Ocular Surface Disease Index (OSDI) score questionnaires after conducting a pilot study on study subjects. The first group of questions was related to the patient’s subjective response to symptoms like eye pain, photophobia/sensitivity to light, and watering/FB sensation. The second group of questions was related to patient satisfaction with regard to vision and surgical outcome. The third group of questions was related to patient’s compliance with treatment. Responses for questionnaires were graded by patients themselves when they came at each visit. While analyzing the scores of questionnaires, they were converted into a percentage for ease of comparison with a lower percentage indicating better subjective responses.
Qualitative data was analyzed using Chi-square test and quantitative data was analyzed using ANOVA test. P value < 0.05 was considered statistically significant.
Results
The mean age of the selected patients in all groups was 62.01 (± 9.59) years (p: 0.54). There were 87 male and 76 female patients, which were randomly distributed between groups (p: 0.713).
At the first visit, 1 week postoperatively, the average value of unaided distant vision measured by logMAR was found to be 0.42, 0.39, 0.39, and 0.43 in groups A, B, C, and D, respectively (p: 0.668). Average pinhole distant vision was 0.25, 0.21, 0.20, and 0.23 in groups A, B, C, and D, respectively (p: 0.311). Unaided near vision had a P value of 0.99 among all the groups. Mean values of Schirmer’s-1 test readings are shown in Fig. 1. Mean Schirmer’s-1 test readings showed a significant difference between group A and other groups (group B – p: 0.009, group D – <0.001), group D and other groups (group B – p: < 0.001, group C – < 0.001). Highest values for readings were noted in group D as compared to other groups. Mean values of TFBUT are shown in Fig. 2. Significant difference was observed between group A and other groups (group B – p: 0.01 and D – < 0.001), group D and other groups (group B – p: < 0.001, group C – < 0.001). Thus, mean reading in group D was maximum and showed a significant difference when compared with the mean readings of the other three groups.
Figure 1.
Comparison of average readings of Schirmer’s-1 test
Figure 2.
Comparison of average readings of TFBUT
At the second visit, 3 week postoperatively, the average unaided distant vision measured by logMAR was 0.37, 0.33, 0.34, and 0.37 in groups A, B, C, and D, respectively (p: 0.771). BCVA for distance was 0.12, 0.13, 0.11, and 0.14 for groups A, B, C, and D, respectively (p: 0.926). BCVA for near vision had a P value of 0.822 among the groups. Mean readings of Schirmer’s-1 test are shown in Fig. 1. Significant differences were observed between group A and other groups (group B – p: 0.0001, group C – p: 0.001, group D – p: 0.0001, respectively) and group D and other groups (group B – p: 0.0001, group C – p: 0.0001). The maximum difference is noted when group D is compared with other groups. Mean readings of TFBUT are shown in Fig. 2. Significant differences were observed between group A and other groups (group C – p: 0.007, group D – p: 0.0001), group B and group C (p: 0.03) and between group D and other groups (group B – p: 0.0001, group C – p: 0.0001). The maximum difference is noted when the mean reading of group D is compared with the mean readings of other groups.
At the third visit, 5 week postoperatively, the average unaided distant vision measured by logMAR was 0.37, 0.33, 0.34, and 0.37 in groups A, B, C, and D, respectively (p: 0.668). Average BCVA for distance was 0.13, 0.13, 0.11, and 0.14 for groups A, B, C, and D, respectively (p: 0.719). BCVA for near vision had a P value of 0.822 among the groups. Mean readings of Schirmer’s-1 test are shown in Fig. 1. Statistically significant difference was noted in between groups (p: < 0.05) with maximum difference noted when group D was compared with other groups. Mean readings of TFBUT are shown in Fig. 2. Significant difference was observed between group D and other groups (group A – p: 0.0001, group B – p: 0.0001, and group C – p: 0.0001) with higher values in group D patients. A comparison of scores of subjective questionnaires at each postoperative visit is shown in Figs. 3 and 4.
Figure 3.
Patient’s subjective response to pain and dry eye symptoms
Figure 4.
Patient satisfaction with their vision and surgical outcome
At the first postoperative visit, a comparison of the average scores of the questions related to patient’s subjective response to pain and dry eye symptoms showed a significant difference between group D and other groups (group A – p: 0.001, group B – p: 0.001, group C – p: < 0.001). Comparing the average scores of questions related to patient satisfaction with surgery and postoperative outcome, a significant difference was noted between group A and other groups (group C – p: < 0.001, group D – p: < 0.001), group B and other groups (group C – p: 0.004, group D – p: < 0.001). Thus, better scores are noted in group C, and group D with no statistical difference noted between groups C and D (p: 0.76). Average scores of questions related to compliance with medical therapy did not have any significant difference among groups (p: > 0.05).
At the second postoperative visit, a comparison of the scores of the questions related to patient’s subjective response to pain and dry eye symptoms showed a significant difference between group A and other groups (group B – p: < 0.001, group C – p: < 0.001, group D – p: < 0.001) with poor scores in group A. Similarly, average scores of questions related to patient satisfaction with surgery and postoperative outcome were poorer in group A compared to groups B, C, and D (p: 0.001, < 0.001, < 0.001, respectively). Average scores of questions related to compliance with medical therapy did not have any significant difference among groups (p: 0.51).
At the third postoperative visit, a comparison of the average scores of the questions related to patient’s subjective response to pain and dry eye symptoms showed a statistically significant difference noted between group A and group D (p: 0.009), while the other groups were comparable to each other (p: > 0.05). Scores of questions related to patient satisfaction with surgery and postoperative outcome (p: 0.53) and for questions related to compliance with medical therapy (p: > 0.05) did not have any significant difference noted between the groups.
Discussion
Cataract is the most commonly performed surgery in ophthalmology. The aim of the surgery is to achieve a good postoperative visual outcome with minimal patient discomfort and improved quality of life. Surgery induces the release of inflammatory mediators such as prostaglandins which affect the blood–retinal barrier and induces inflammation, which affects the outcome and patient satisfaction with the surgery. Dry eye features are common following cataract surgery.[1] Steroids, NSAIDs, mydriatics, and lubricating eye drops are the most commonly used drugs following cataract surgery in various regimens with no common consensus between ophthalmologists regarding the best and most effective regimen. In our study, we compared the effectiveness of various treatment protocols to evaluate their objective and subjective effects with respect to dry eye features and patient satisfaction.
Multiple factors contribute to tear-film instability after cataract surgery like damage to corneal structures by surgery, adverse effects of topical anesthesia, and benzalkonium chloride-containing eye drops, and exposure to intense light from the operating microscope, with resultant adversely affected ocular surface.[2,3] This can lead to a vicious cycle of tear-film instability, tear-film hyperosmolarity, apoptosis of conjunctival and corneal cells, and inflammation.[4] Dry-eye disease symptoms can reduce a patient’s quality of life, interfering with the ability to perform daily routine activities[5], which can be prevented by timely and effective treatment.[3,6] Carboxy methyl cellulose (CMC) 0.5% has lubricating and cell binding properties that allow it to remain on the ocular surface for a pronged period of time.[7] It helps to protect the ocular surface, stabilizes tear film, and provides symptomatic relief from dry eye-related symptoms like FB sensation, irritation, watering, and photophobia. Dry eye-related symptoms can occur soon after cataract surgery and may persist late into the postoperative period.
In our study, dry eye features were assessed objectively by measuring Schirmer’s-1 test and TFBUT postoperatively at each postoperative visit. Comparing Schirmer’s-1 test readings at each postoperative visit, values were found to be statistically significant (p: 0.0001) in between the groups with the highest mean readings noted in group D as compared to other groups at each postoperative visit. Although readings were improving at each subsequent visit in all the groups, readings of group D were consistently higher as compared to other groups. Similarly, on comparing the results of TFBUT at each postoperative visit, readings were found to be statistically significant (p: 0.0001) between the groups with highest mean readings noted in group D as compared to other groups.
At first postoperative visit at 1 week, mean TFBUT readings of all the groups were found to be below normal (<10 s); however, they were significantly higher in group D as compared to other groups. At subsequent visits at 3 and 5 weeks postoperatively, mean readings in group D were found to be normal (>10 s), which were significantly higher than the mean readings of other groups. The low readings of TFBUT may be due to the presence of preservatives in topical eye drops (which act like detergents causing the breakdown of the lipid layer of tear), exposure to light of microscope, and frequent irrigation of cornea as they could cause toxicity to the cornea and conjunctiva. As there is a decrease in dosing frequency at subsequent visits, improvement in the readings can occur. CMC consists of lubricating and cell binding properties that allow it to remain on the ocular surface for a longer period of time.[7] In our study, CMC 0.5% was added in group D in addition to other drugs. Schirmer’s-1 test and TFBUT readings were comparatively better in group D as compared to other groups.
In a study conducted by Gupta et al.[8] comparing dry eye caused by phacoemulsification in different age groups in senile cataract patients with no preexisting dry eye, they found that Schirmer’s-1 test readings and TFBUT readings were lowest at 1 week postoperatively, which gradually improved to normal values by 12 weeks postoperatively, indicating that phacoemulsification surgery affects tear film stability and tear production postoperatively. However, they did not compare various medications to compare their effectiveness postcataract surgery. In a study by Mencucci et al.[9] to compare the effect of adding artificial tears (combination of sodium hyaluronate 0.1% and carboxymethylcellulose 0.5%) to that of steroid antibiotic combination, they found out that TFBUT and OSDI scores were significantly better and patients were symptomatically better in the study group than the control groups indicating that artificial tears help in reducing dry eye-related features after cataract surgery. This result is similar to the result found in our study.
At the first visit, 1 week postoperatively, comparing average scores of questions related to pain and dry eye symptoms, in our study statistically significant difference was noted (p: 0.0001) between groups with better scores in group D as compared to other groups and maximum difference is noted when group C and D are compared with other groups (p: < 0.001). On subsequent visits, there was no significant difference noted among the groups at the second and third postoperative visits (p: 0.19 and 0.05, respectively). However, scores of group D were better as compared to other groups suggestive of less pain and dry eye-related symptoms like FB sensation, watering, and photophobia at subsequent visits. Symptoms of dry eye disease, such as FB sensation and irritation, are common after cataract surgery which usually occurs at 1 week postoperatively and improves gradually postoperatively over time.[1,3] In a study done by Mencucci et al.[9] they concluded that the use of sodium hyaluronate 0.1% and carboxymethylcellulose 0.5% helps to improve tear film stability and decrease dry eye-related symptoms and which can improve the quality of life following phacoemulsification cataract surgery. Similar results were noted in our study with better TFBUT and Schirmer’s-1 test readings, and patients were symptomatically better at 1 week postoperatively in group D (patients using CMC 0.5% eye drops), suggesting less dry eye-related symptoms in group D as compared to other groups. However, at subsequent visits at 3 week and 5 week postoperatively, there was no significant difference in similar symptoms as there was a decrease in the dosing frequency of eye drops, healing of corneal epithelium, as well as NSAIDs also had some pain-relieving action. Effective postoperative management of the ocular surface might increase patient satisfaction with the surgical outcome.[10] A study by Garrett Q et al.[7] concluded that CMC-containing eye drops stimulates the healing of the corneal epithelium. Ocular pain is better controlled with NSAIDs as compared to steroids in the early postoperative periods.[11,12] Similar result is seen in our study with better scores noted in groups C and D at the first postoperative visit as compared to other groups (NSAIDs – nepafenac 0.1% eye drop is prescribed in both the groups).
Comparing scores of patient satisfaction with their vision and surgery, at the first postoperative visit, better scores were noted in groups C and D (using NSAIDs and CMC) with no statistical difference noted between them (p: 0.76). This suggests that patients in these groups were more satisfied with their vision and surgery at the first postoperative visit as compared to other groups. This may be due to improved pain and dry eye-related symptoms by the use of NSAIDs and CMC eye drops in groups C and D associated with better quality of life as compared to groups A and B as noted in comparison of mean scores of previous questionnaires.
Scores related to compliance with medical therapy did not show significant differences between the groups at each postoperative visit at 1 week, 3 week, and 5 week postoperatively (p: 0.35, 0.51 and 0.12, respectively). More drugs can lead to less compliance with therapy, and a patient may forget to put the eye drops; however, in our study, compliance with therapy was found to be good as evidenced in the results. But as the response was graded by patients themselves regarding putting the drops regularly, they might have given misleading information about the same, which could not be cross-checked objectively.
There were a few limitations in this study. First, although the patients were clinically examined for symptoms and signs of dry eyes, assessments of dry eyes using tests such as Schirmer’s and TBUT were not performed preoperatively. Furthermore, although there are many other tests for assessing dry eyes, such as staining, tear osmolarity, matrix metalloproteinease-9 test, etc., we restricted our evaluation to the rapid, time-tested, Schirmer’s and TBUT tests. Phaco-time was not analyzed as we studied only patients with uncomplicated phacoemulsification surgery done by two experienced surgeons. However, this could have induced minimal bias in the study.
Conclusion
This study found that the addition of topical lubricants and NSAIDs to the postphacoemulsification medication regime helped improve postoperative dry eye-associated symptoms, signs, and patient satisfaction and is, hence, recommended.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
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