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A comparative assessment of punctal plugs versus artificial tears for treating dry eye
*Corresponding author: Aarti Hitendrabhai Dave, Department of Ophthalmology, M and J Institute of Ophthalmology, B.J. Medical College and Civil Hospital, Ahmedabad, 380016, India. 2011aarti@gmail.com
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Received: ,
Accepted: ,
How to cite this article: Bhatt RB, Dave AH, Shah AV. A comparative assessment of punctal plugs versus artificial tears for treating dry eye. BJKines - Natl J Basic Appl Sci. doi: 10.25259/BJKines_23_2026
Abstract
Introduction:
Dry eye disease (DED) is a multifactorial disorder of the ocular surface characterized by tear film instability, ocular discomfort, visual disturbances, and inflammation. Artificial tears are the most commonly prescribed first-line treatment, whereas punctal plugs provide a longer-lasting approach by reducing tear drainage. This study attempted to compare the efficacy of punctal plugs and artificial tears to prevent DED.
Material and Methods:
A prospective, observational comparative study was conducted among 39 patients diagnosed with mild, moderate, and severe DED, where 20 cases for punctal plugs and 19 cases for artificial tears were selected. Clinical outcomes, including symptomatic score, ocular surface disease index, Schirmer's test, tear break-up time, and corneal fluorescein staining, were assessed at baseline and after 3 months of treatment.
Results:
Both treatment groups demonstrated significant recovery in symptoms and tear film parameters. In the present study, punctal plugs and artificial tears have a remarkable enhancing effect on improving symptom score and DES parameters in post-treatment. But there was no statistically significant difference between the two groups. No major adverse effects were obtained.
Conclusion:
In the present study, punctal plugs and artificial tears had a remarkable preventive effect on improving symptom scores and DES parameters in post-therapy. But there was no statistically significant difference between the two groups. This study suggests that punctual plugs do not play a role in forming tears, but it surely helps to prevent DED by blocking the tear drainage pathway and holding the natural tears in the eyes for a longer period.
Keywords
Artificial tears
Dry eye disease
Ocular surface disease
Punctal plugs
Tear film
INTRODUCTION
Dry eye disease (DED) is identified as a multifactorial disorder of the ocular surface exhibited by tear film instability, hyperosmolarity, inflammation, surface damage, and neurosensory dysfunction. It results in a breakdown of tear film homeostasis and associated symptoms, which vary based on the interplay of environmental, physiological, and neurological components, necessitating a comprehensive approach to diagnosis and treatment.1
Generally, the ocular surface (cornea, conjunctiva, accessory lacrimal glands), meibomian glands (specific sebaceous glands of the eyelid margin that generate the outer lipid film of the tear film), the main lacrimal gland, and the innervation between them form a functional unit. Any or all of these structures may be affected in DED.2
Depending on age, sex, geographical area, environmental factors, and diagnostic criteria, the incidence of dry eye varies from 5% to 50%. The increasing prevalence of DED may be attributed to a number of causes, including more time spent in front of screens, an aging population, hormonal changes, autoimmune disorders, and environmental toxins.3
Even if several pathogenic variables are involved, there is currently no consensus on the diagnostic criteria or illness classification of DED.4 Furthermore, those with DED typically have a lower quality of life, especially while carrying out near-vision chores or using video terminals, which may restrict their everyday activities and living surroundings.5
Because of their accessibility and safety profiles, artificial tears continue to be the primary method of therapy and are frequently recommended. These lubricative liquids momentarily improve ocular comfort and replenish the tear film. However, patient compliance might be reduced by regular administration and a limited length of action.6 Although the 2017 tear film and ocular surface society (TFOS) dry eye workshop (DEWS II) emphasized that there had been relatively few high-quality randomized controlled trials comparing different formulations with each other, the majority of artificial tear preparations have been shown to be effective in reducing the symptoms and signs of DED.7,8
Little biocompatible devices called punctal plugs are implanted into the lacrimal puncta to reduce tear outflow and increase tear retention on the surface of the eyes. Punctal occlusion prolongs symptomatic alleviation and may enhance tear film stability by maintaining natural and artificial tears.9 Many studies reported that punctal plugs are efficacious for treating DED signs and symptoms.6,9-12 Moreover, a recent systematic review and meta-analysis revealed that punctal plugs are an efficacious and safe therapy.13 This study is lacking in the western part of India. Therefore, this study attempted to compare punctal plugs and artificial tears in the management of DED.
MATERIALS AND METHODS
Study design
This research was performed as a prospective, observational comparative study after obtaining the approval of the “institutional ethics committee (IEC)”. Written informed consent was obtained from all the studied patients.
Study setting
This study was carried out in the Ophthalmology Department, M. & J. Institute of Ophthalmology, B.J. Medical College, and Civil Hospital, Ahmedabad, India, a tertiary healthcare center.
Study duration
This study was performed for the period of 12 months (from June 2023 to June 2024).
Study population
Patients diagnosed with mild, moderate, and severe DED who visited the ophthalmology outpatient department. A total of 39 patients were categorized for temporary punctal plugs (silicon-made), used (n=20), and for artificial tears (n=19).
Inclusion criteria
The patients who were willing to participate, patients from 21 to 60 years of age presenting DED with mild, moderate, and severe grades, and the patients with bilaterally symmetrical DED, in which one eye was considered the study eye.
Exclusion criteria
The patients who were unwilling to follow up, refused consent, DED due to “trachoma, cicatricial pemphigoid, chemical injury or Steven-Johnson syndrome”, DED due to contact lens wear, diabetes, refractive surgery, neurotrophic keratitis, DED due to systemic drug toxicity, and DED due to allergic conjunctivitis or blepharitis, and evaporative dry eyes.
Data collection
Demographic profile: Age- and gender-wise symptom scores and OSDI scores were recorded.
Symptom scores: Each symptom was graded subjectively by asking the patients to grade on a scale of 0 to 3, with 0 meaning “absent” and 3 meaning “always present”. Scores were compiled for 15 distinct criteria and categorized as mild (0-6), moderate (7-12), or severe (13-18).
Ocular surface disease index (OSDI): The total OSDI score was calculated based on the following formula: OSDI = [(sum of scores for all questions answered) × 100]/[(total number of questions answered) × 4]. Therefore, the OSDI score is calculated on a scale of 0-100, where higher values indicate severe disorder.
Schirmer's test: The test was performed by placing a Whatman (no.41) filter paper inside the lower lid margin at the junction of the medial two-thirds and the lateral one-third of the eye. After 5 minutes, the paper was removed and examined for the moisture content. For the right and left eyes were examined at the same time, and their judgment was based on DEWS 2 guidelines, which were recorded as grades, viz., 1 (>10 mm), 2 (<10 mm), 3 (<5 mm), and 4 (<2 mm), respectively.
Tear film break-up time (TBUT): Fluorescein was inserted into the tear film of patients, and the patient was instructed to refrain from blinking as the tear film was examined under a large cobalt blue light beam. TBUT was determined by measuring how long it took in seconds for the first dry area to show up in the tear film after the last blink. A TBUT below 10 s is considered abnormal, and grading was done for the right and left eyes, respectively, as Grades 1 (>10 s), 2 (<10 s), 3 (<5 s), and 4 (immediate).
Corneal fluorescein staining (F-stain): The surface of the eye received contact with a portion of the blotting paper that had the dye in it. Blinking was asked of the patient. The dye is spread by blinking after coating the corneal surface with the tear film. Any ocular surface anomaly was identified and graded using a standard chart (Oxford scheme), and the grading was done as grades 1 (None to mild), 2 (Variable), 3 (Marked central), and 4 (Severe punctate erosions), respectively, right and left eyes under the cobalt blue filter.
The follow-up period was maintained for 30 days and 90 days.
Statistical analysis
All the data was entered in a Microsoft Excel sheet. By using SPSS software (version 23), data were statistically analyzed and interpreted. The mean ± standard deviation was calculated for continuous variables. Pre- and post-treatment were compared using a Student's t-test. The significant differences were judged statistically at a p<0.05 level.
RESULTS
In this study [Table 1], the mean age of the patients was 43.51 years, with ages ranging between 21 and 60 years. In this study group, the majority of patients had a higher symptom score between the ages of 41 and 50 years. For the age group, out of 39 patients, the symptom score was indicated as mild (n=18), moderate (n=15), and severe (n=6), respectively. For gender, out of 39 patients, the symptom score reveals mild (n=16), moderate (n=15), and severe (n=8), respectively. Out of 39 patients, 22 cases were female patients, where mild (n=10), moderate (n=8), and severe (n=4) symptoms were obtained. Amongst 17 male patients, mild (n=6), moderate (n=7), and severe (n=4) symptoms were obtained.
| Demographic profiles | Symptom score | |||
|---|---|---|---|---|
| Mild | Moderate | Severe | Total | |
| Age groups (Years) | ||||
| 21-30 | 3 | 3 | 0 | 6 |
| 31-40 | 5 | 2 | 0 | 7 |
| 41-50 | 7 | 5 | 4 | 16 |
| 51-60 | 3 | 5 | 2 | 10 |
| Total | 18 | 15 | 6 | 39 |
| Sex | ||||
| Male | 6 | 7 | 4 | 17 |
| Female | 10 | 8 | 4 | 22 |
| Total | 16 | 15 | 8 | 39 |
In our study [Table 2], for the age group, out of 39 patients, the OSDI score was observed as mild (n=20), moderate (n=12), and severe (n=7). In this study group, the majority of patients obtained higher OSDI scores in the age of 41-50 years, in which mild (n=8), moderate (n=4), and severe (n=4) were observed. For gender, out of 39 patients, 22 were female patients, where OSDI scores were mild (n=12), moderate (n=6), and severe (n=4), respectively. Amongst 17 male patients, where the OSDI score was mild (n=8), moderate (n=6), and severe (n=3), respectively
| Demographic profiles | OSDI score | |||
|---|---|---|---|---|
| Mild | Moderate | Severe | Total | |
| Age groups (Years) | ||||
| 21-30 | 3 | 3 | 0 | 6 |
| 31-40 | 5 | 2 | 0 | 7 |
| 41-50 | 8 | 4 | 4 | 16 |
| 51-60 | 3 | 3 | 4 | 10 |
| Total | 19 | 12 | 8 | 39 |
| Sex | ||||
| Male | 8 | 6 | 3 | 17 |
| Female | 12 | 6 | 4 | 22 |
| Total | 20 | 12 | 7 | 39 |
OSDI: Ocular surface disease index
Table 3 evaluates quantitative changes in different scores based on pre- and post-treatments. For symptom score, the mean of the in-punctal plug treatment was significantly (p<0.01) reduced from 7.13 to 4.30, and the mean of the artificial tear treatment was significantly (p<0.05) reduced from 7.24 to 5.30. For the OSDI score, the mean of the Punctal Plug treatment was significantly (p<0.001) reduced from 22.81 to 14.16, and the mean of the artificial tears treatment was significantly (p<0.01) reduced from 22.85 to 17.19. For Schirmer’s grade, the mean of the punctal plug treatment significantly (p<0.01) decreased from 2.56 to 1.54, and the mean of the artificial tear significantly (p<0.05) decreased from 2.61 to 1.56. For TBUT grade, the mean of the punctal plug treatment significantly (p<0.05) decreased from 1.86 to 1.13, and the mean of the artificial tear significantly (p<0.01) decreased from 1.81 to 1.08. For F-stain grade, the mean of the punctal plug treatment significantly (p<0.05) decreased from 1.82 to 1.34, and the mean of the artificial tear significantly (p<0.05) decreased from 1.84 to 1.39.
| Treatments | Pre | Post | Total samples |
|---|---|---|---|
| System score | |||
| Punctal plugs (M ± SD) | |||
| 7.13 ± 3.68 | 4.30 ± 1.30** | 20 | |
| Artificial tears (M ± SD) | 7.24 ± 3.15 | 5.30 ± 2.10*** | 19 |
| OSDI score | |||
| Punctal plugs (M ± SD) | 22.81 ± 7.69 | 14.16 ± 2.80* | 20 |
| Artificial tears (M ± SD) | 22.85 ± 8.16 | 17.19 ± 4.50** | 19 |
| Schirmer’s grade | |||
| Punctal plugs (M ± SD) | 2.56 ± 1.10 | 1.54 ± 0.70** | 20 |
| Artificial tears (M ± SD) | 2.61 ± 1.17 | 1.56 ± 0.72*** | 19 |
| TBUT grade | |||
| Punctal plugs (M ± SD) | 1.86 ± 0.93 | 1.13 ± 0.41*** | 20 |
| Artificial tears (M ± SD) | 1.81 ± 0.87 | 1.08 ± 0.39** | 19 |
| F-stain grade | |||
| Punctal plugs (M ± SD) | 1.82 ± 0.84 | 1.34 ± 0.34*** | 20 |
| Artificial tears (M ± SD) | 1.84 ± 0.91 | 1.39 ± 0.39*** | 19 |
Main side effects include fibrosis of canaliculi, expulsion of the punctal plugs, and irritation of the conjunctiva.
DISCUSSION
DED is a common ocular surface disorder that causes persistent visual disturbance, discomfort, and has an adverse impact on the patient’s quality of life.14 It is caused by either abnormal tear production or tear film instability. There are multiple treatment options available for symptomatic relief in DED.15 In the present study, we evaluated the efficacy of punctal plugs and artificial tears on tear film quality, quantity, and other dry eye syndrome (DES) parameters based on the OSDI score.
Even though both groups resulted in substantial reductions in dry eye discomfort following treatment, there were no between-group variations in the average dry eye questionnaire ratings. Both treatments are equally effective at improving dry eye-related ocular irritation, as per the present research outcomes. This study is supported by Qiu et al.10
Patients who suffer from DES present with symptoms, viz., burning, itching, redness, ocular fatigue, sensitivity to light, and blurred vision, which may create a hazardous impact on their quality of life. Liu et al.16 evaluated that symptom scores in Sjogren syndrome (SS) group were significantly (p<0.05) higher compared with the non-SS group at the baseline. After the obstruction, they were significantly (p<0.05) improved in both groups at every visit compared with the baseline.
In our study, for symptom scores, the mean of the inpunctal plug treatment indicated a significant (p<0.01) reduction from 7.13 to 4.30, and the mean of the artificial tear treatment also indicated a significant (p<0.05) reduction from 7.24 to 5.30. As compared to other studies, the overall symptom score showed significant improvement at 1-month post-treatment of punctal plugs. Ervin et al.9 observed that there was little or no improvement in symptom scores with punctal plugs compared without punctal plugs.
In our study, for the OSDI score, the mean of the in-punctal plug treatment was significantly (p<0.001) reduced from 22.81 to 14.16, and the mean of the artificial tear treatment was significantly (p<0.01) reduced from 22.85 to 17.19. Qiu et al.10 compared the effects of treatment with punctal plugs versus artificial tears on visual function and tear film stability for dry eye. These symptoms were relieved after the application of artificial tears or punctal plugs, but there was no significant difference between these two groups.
In our study, for Schirmer’s grade, the mean of the punctal plug treatment significantly (p<0.01) decreased from 2.56 to 1.54, and the mean of the artificial tears significantly (p<0.05) decreased from 2.61 to 1.56.
Patients who did punctal plugs have greater tear retention, according to an improvement in Schirmer's test readings. Punctal plugs keep naturally produced tears longer, while artificial tears momentarily supplement the tear film.10 Shi et al.17 stated that compared with the baseline data, Schirmer’s test score improved significantly after plug insertion at 6 months follow-up, and the requirement of eyedrops was also decreased with statistically significant results.
In our study, for the TBUT grade, the mean of the Punctal Plug treatment significantly (p<0.05) decreased from 1.86 to 1.13, and the mean of the artificial tear significantly (p<0.01) decreased from 1.81 to 1.08.
Qiu et al.10 compared the effects of punctal plugs vs artificial tears on visual function and noticed that TBUT was improved significantly after treatment in both groups, but the improvement was greater in patients who received punctal plugs than artificial tears. In another study by Qiu et al.,18 reported that the comparison between punctal plugs and artificial tears in SS, the TBUT values were significantly improved in the punctal plugs group when compared to the artificial tears group.
In our study, for the F-stain grade, the mean of the punctal plug treatment significantly (p<0.05) decreased from 1.82 to 1.34, and the mean of the artificial tear significantly (p<0.05) decreased from 1.84 to 1.39.
Qiu et al.18 did a comparative assessment between punctal plugs and artificial tears in SS, in which corneal fluorescein staining scores obtained statistically significant results in the punctal plug group. Ibrahim et al.19 observed that fluorescein staining scores showed significant (p<0.05) improvement after punctal occlusion at 1 month.
In our study, no major adverse effects were observed, and only 2 patients experienced some irritation and foreign body sensation, but did not require removal of the punctual plugs. Artificial tears (carboxymethyl cellulose) used in this study were safe and well-tolerated by the patients.
LIMITATIONS
Single-center investigation: This study was performed in a tertiary care hospital. Smaller sample size: The sample size was limited to 39 cases only. Shorter follow-up period: This study was a time-bound investigation. So, the follow-up period was for a short duration. Lacking randomization: Due to a smaller sample size, the randomization did not perform.
CONCLUSION
In the present study, punctal plugs and artificial tears had a remarkable preventive effect towards improving symptom scores and DES parameters in post-therapy. However, there were no statistically significant differences in post-treatment results between the two groups. This study suggests that punctual plugs do not play a role in forming tears, but it surely helps to prevent DED by blocking the tear drainage pathway and holding the natural tears in the eyes for a longer period.
It improves patient compliance and comfort, decreases follow-up visits, and thus becomes a cost-effective alternative compared to standard artificial tears. Punctal plug has the side effects, which include fibrosis of canaliculi, expulsion of the punctal plugs, and irritation of the conjunctiva. So, we recommend the use of punctual plugs to minimize symptoms in DED. The findings of our study suggest that punctal plugs (temporary silicone plugs) improve symptoms in DED.
Author contributions:
RB: Research concept, methodology, supervision of the entire research, review and final editing; AD: Validation, resources, writing and critical review of the manuscript; AVS: Investigation (conducting the research, patient enrolment and follow-up), data curation, analysis and results tabulating, original draft preparation.
Ethical approval:
The research/study was approved by the Institutional Review Board at B.J Medical College & Civil Hospital, number 94/2023, dated 30.12.2023.
Declaration of patient consent:
The authors certify that they have obtained all appropriate patient consent forms. In the form, the patients have given their consent for their clinical information to be reported in the journal. The patients understand that their names and initials will not be published and due efforts will be made to conceal their identity, but anonymity cannot be guaranteed.
Conflicts of interest:
There are no conflicts of interest.
Use of artificial intelligence (AI)-assisted technology for manuscript preparation:
The authors confirm that there was no use of artificial intelligence (AI)-assisted technology for assisting in the writing or editing of the manuscript and no images were manipulated using AI.
Financial support and sponsorship: Nil.
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