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. 2026 Mar 12;26:128. doi: 10.1186/s12886-026-04727-7

Ocular changes in patients on Topiramate therapy: a hospital-based comparative study

Manaswini Patro 1, Suchismita Mishra 1, Srimant Pattnaik 2, Pradeep Kumar Panigrahi 1,
PMCID: PMC12980903  PMID: 41820984

Abstract

Background

To evaluate the effect of newly administered Topiramate therapy on various ophthalmological parameters.

Methods

This was a hospital-based, prospective, non-randomized, longitudinal, comparative study conducted in the Department of Ophthalmology at a tertiary care hospital from August 2024 to March 2025. Patients aged between 18 and 40 years, and newly initiated on Topiramate therapy by the department of Neurology, were recruited in the study and constituted the study group. Age- and gender-matched healthy individuals constituted the control group. A comprehensive ophthalmic evaluation was done in every case. Ocular parameters studied were intraocular pressure (IOP), central corneal thickness (CCT), anterior chamber depth (ACD), lens thickness (LT), and peripapillary retinal nerve fiber layer (RNFL) thickness. Assessment was performed at baseline and at 15 days, 1 month, and 3 months following Topiramate therapy.

Results

A total of 160 eyes of 80 patients (40 patients newly initiated on Topiramate therapy and 40 healthy controls) were analyzed in the study. The mean age was 30.27 ± 4.83 years and 30.7 ± 4.6 years, respectively, in both groups. Significant increases were observed in IOP (from 13.46 ± 1.71 mm Hg to 18.18 ± 2.48 mm Hg, P < 0.001), CCT (from 516.76 ± 34.58 μm to 524.38 ± 36.04 μm, P < 0.001), LT (from 3.81 ± 0.33 mm to 3.85 ± 0.33 mm, P < 0.001), and peripapillary RNFL thickness (P < 0.001 in all quadrants). ACD showed a significant reduction over time (P < 0.001), and a progressive myopic shift was noted (-0.20 ± 0.39 D to -0.37 ± 0.33 D, P < 0.001).

Conclusion

The findings of the present study highlight the need for routine ophthalmic evaluations in patients on Topiramate to detect early changes and prevent vision-threatening complications. Given the progressive nature of these alterations, early intervention and close monitoring are crucial for patient safety.

Keywords: Ocular, Topiramate, Therapy, Intraocular pressure, Anterior chamber depth

Background

Topiramate, a widely prescribed anticonvulsant and mood stabilizer, is used for various neurological and psychiatric conditions, including epilepsy, migraine prophylaxis, bipolar disorder, and neuropathic pain [1]. Despite its therapeutic benefits, Topiramate has been linked to several ocular complications, the most concerning of which include acute angle-closure glaucoma (AACG), myopic shift, and changes in the anterior segment parameters [14]. These effects can significantly impact visual function and, if unrecognized, may lead to severe visual impairment.

The mechanism behind these ocular changes is not entirely understood but is believed to involve supraciliary effusion, which causes forward displacement of the lens-iris diaphragm [5]. This can result in shallowing of the anterior chamber, increased intraocular pressure, and potential optic nerve damage [6]. The inhibition of carbonic anhydrase by Topiramate may also contribute to these changes by disrupting aqueous humor dynamics and altering corneal and lens hydration [59].

Although various case reports have established the ocular effects of Topiramate using anterior segment optical coherence tomography (OCT), ultrasound biomicroscopy, gonioscopy, and Scheimpflug imaging, studies comparing its impact on multiple ocular parameters over time are limited [1013]. Given the increasing use of Topiramate in clinical practice, it is crucial to understand its potential risks and establish guidelines for early detection and management of drug-induced ocular changes. There is a paucity of studies on ocular changes in patients on Topiramate therapy. To date, to the best of our knowledge, no studies on the Indian population have reported the effect of Topiramate therapy on the eye.

This study aims to comprehensively evaluate the effects of newly administered Topiramate on various ophthalmological parameters, including refractive status, intraocular pressure (IOP), central corneal thickness (CCT), anterior chamber depth (ACD), lens thickness (LT), and peripapillary retinal nerve fibre layer (RNFL) thickness. By identifying patterns and progression of ocular changes, we seek to provide insights into the need for ophthalmic monitoring in patients receiving Topiramate therapy.

Methods

This was a hospital-based, prospective, non-randomized, longitudinal, comparative study conducted in the Department of Ophthalmology in association with the Department of Neurology of a multi-speciality hospital in Eastern India from August 2024 to March 2025. Institutional ethical clearance (IEC/IMS.SH/SOA/2024/851) was obtained before commencement of study, and written informed consent was obtained from each patient before the start of the study. The study adhered to the basic tenets of the Helsinki Declaration.

Patients aged 18 to 40 years, who were newly initiated on Topiramate therapy by the department of Neurology, were recruited for the study and constituted the study group. Age- and gender-matched healthy individuals constituted the control group. Patients with a history of ocular trauma, intraocular surgery, ocular diseases (glaucoma, cataract, diabetic retinopathy, age-related macular degeneration, congenital ocular malformations, etc.), systemic diseases (hypertension, diabetes mellitus, renal failure, anemia, etc.), pregnancy, smoking, and use of Topiramate in the last 3months were excluded from the study. The Raosoft online sample size calculator was used to estimate the sample size. Using a 95% confidence level, an initial sample size of 40 per group was estimated. The final sample size deemed adequate for the study was 86 participants (43 patients receiving topiramate and 43 age- and gender-matched healthy controls).

After obtaining written informed consent, a thorough history regarding patient age, gender, address, indication for Topiramate therapy, therapeutic dose, associated systemic conditions, and history of any other drug intake, any past history of surgery or trauma to the eye was recorded. Comprehensive ophthalmic evaluation was done in each case, which included assessment of best-corrected visual acuity (BCVA), pupillary reactions, IOP measurement using Goldmann’s applanation tonometer, slit-lamp based anterior segment examination, dilated fundus examination using slit-lamp biomicroscopy, and indirect ophthalmoscopy. Gonioscopy was performed at baseline to rule out angle-closure glaucoma. Along with the above ocular examination, CCT, ACD, and LT were measured using IOL Master 700 (Carl Zeiss Meditec, Jena, Germany). Peripapillary RNFL thickness was measured using spectral domain OCT (3D OCT Maestro, Topcon Corporation, Tokyo, Japan) after proper alignment. Three scans were recorded using the 3D disc protocol with a scan length of 6 × 6 mm and a resolution of 512 × 128. Good quality scans of signal strength more than six without any artefact or RNFL discontinuity were considered.

The average 360º peripapillary RNFL thickness and quadrant (Superior, nasal, inferior, and temporal) thicknesses were recorded. All these investigations were performed at baseline (before initiation of Topiramate therapy)at 15 days, at 1 month, and at 3 months after commencement of the drug therapy. All measurements were performed at the same time of the day to rule out diurnal variations. To reduce biases, initial and follow-up ophthalmological assessments were performed by the same examiner. IOL Master and OCT measurements were done by MS and PKP, respectively. During follow-up, patients were asked about any systemic or ocular side effects of the drug, such as ocular pain, blurred vision, and red eye. All patients were initially treated with a daily dose of 50 mg (25 mg BD), which was continued throughout the study period if disease symptoms remained under control. The dose was escalated to 100 mg/day if symptoms remained uncontrolled after one month of treatment initiation.

Statistical analysis

Statistical analysis was performed using the Statistical Package for Social Sciences (SPSS version 24.0). Continuous variables were represented as mean (± standard deviation) and median. Categorical variables were presented as absolute numbers and frequencies. Repeated analysis of variance (ANOVA) was used to compare continuous variables across different time points. A paired Student t-test with Bonferroni post hoc test was used to compare continuous variables at each time point. For post hoc pairwise comparisons, the Bonferroni correction was applied to adjust for multiple testing and minimize Type I error inflation. A p-value ≤ 0.05 was considered to be statistically significant.

Results

The current study included 160 eyes from 80 patients, 40 patients (80 eyes) were in the Topiramate study group and 40 healthy patients (80 eyes) were in the control group, with a mean age of 30.27 ± 4.83 years and 30.7 ± 4.6 years, respectively. Three patients in the study group were lost to follow-up. Females constituted the majority in both groups (87.5% in the Topiramate group and 82.5% in the control group). The most common indication for Topiramate use was migraine (72.5%), followed by epilepsy (27.5%). The mean daily dose of Topiramate was 56.2 ± 16.6 mg in our study. Only 5 patients needed a higher dose of 100 mg/day to bring the migraine symptoms under control.

Mean IOP increased significantly from 13.46 ± 1.71 mm of Hg at baseline to 18.18 ± 2.48 mm of Hg at 3 months (P < 0.001). Similarly, there was a statistically significant increase in mean CCT from 516.76 ± 34.58 μm at baseline to 524.38 ± 36.04 μm at the end of 3 months (P < 0.001). Mean LT was 3.81 ± 0.33 mm and 3.85 ± 0.33 mm at baseline and end of 3 months, respectively (P < 0.001). Baseline ACD decreased significantly over time (P < 0.001)[Figure 1]. We observed a myopic shift (-0.20 ± 0.39 D to -0.37 ± 0.33 D, P < 0.001) at the end of the study follow-up period [Table 1]. Peripapillary RNFL showed a statistically significant increase in average and all quadrants RNFL thickness over the 3 months study period (P < 0.001) [Table 2][Figure 2].

Fig. 1.

Fig. 1

Graphical representation of change in mean intraocular pressure, central corneal thickness, lens thickness, and anterior chamber depth in the study group over a period of time

Table 1.

Change in ocular parameters in patients on Topiramate therapy

Parameter Baseline. 15 Days 1 Month 3 Months P-value
Refraction (Diopters) -0.20 ± 0.39 -0.30 ± 0.33 -0.36 ± 0.33 -0.37 ± 0.33 < 0.001

IOP

(mm Hg)

13.46 ± 1.71 15.18 ± 2.17 16.27 ± 2.06 18.18 ± 2.48 < 0.001
CCT (µm) 516.76 ± 34.58 521.98 ± 35.26 522.30 ± 35.36 524.3 ± 36.04 < 0.001
LT (mm) 3.81 ± 0.33 3.83 ± 0.33 3.85 ± 0.33 3.85 ± 0.33 < 0.001
ACD (mm) 3.38 ± 0.31 3.35 ± 0.31 3.35 ± 0.30 3.35 ± 0.33 < 0.001

IOP: Intraocular pressure; CCT: Central corneal thickness; LT: Lens thickness; ACD: Anterior chamber depth

Table 2.

Change in peripapillary retinal nerve fibre layer thickness in patients on Topiramate therapy

RNFL (µm) Baseline 15 Days 1 Month 3 Months P-value
Average 100.94 ± 15.98 101.78 ± 16.01 104.98 ± 16.19 105.82 ± 16.13 < 0.001
Superior 131.40 ± 18.79 132.38 ± 18.61 136.39 ± 19.24 136.96 ± 18.90 < 0.001
Inferior 135.55 ± 19.96 136.94 ± 19.75 140.00 ± 19.85 141.62 ± 20.39 < 0.001
Nasal 73.35 ± 13.06 73.26 ± 13.48 76.35 ± 13.81 76.94 ± 13.61 < 0.001
Temporal 63.49 ± 12.10 64.45 ± 12.04 67.19 ± 11.88 67.76 ± 11.63 < 0.001

RNFL: Retinal nerve fibre layer

Fig. 2.

Fig. 2

Graphical representation of change in average retinal nerve fibre layer thickness between the 2 groups over a period of time

Post hoc analysis using Bonferroni correction revealed that Topiramate administration resulted in statistically significant changes in several ocular parameters over time [Table 3]. IOP showed a significant increase over time. Refraction demonstrated a statistically significant myopic shift at 3 months compared to baseline (P = 0.0069). LT exhibited a significant rise from baseline to each follow-up point, with the most pronounced changes occurring within the first month, and CCT showed pronounced changes within 15 days. A significant reduction in ACD was observed from baseline to 3 months follow-up. Additionally, peripapillary RNFL thickness showed significant increases in the average, superior, inferior, and temporal quadrants in all follow-up points, with most changes reaching high statistical significance (P < 0.001). Post hoc analysis in our study highlights the timeline and magnitude of changes that are not evident from comparisons alone.

Table 3.

Comparison of ocular parameters across different time points in the Topiramate case group using Bonferroni Post hoc correction

Parameter Baseline Baseline vs. 1 M Baseline vs. 3 M 15 days vs. 1 M 15 days vs. 3 M 1 M vs. 3 M

IOP

(mm Hg)

< 0.001 < 0.001 < 0.001 < 0.001 < 0.001 < 0.001
CCT (µm) < 0.001 < 0.001 < 0.001 0.067 0.187 0.255
LT (mm) < 0.001 < 0.001 < 0.001 0.04 0.04 0.6
ACD (mm) < 0.001 < 0.001 < 0.001 0.05 0.05 0.05
Refraction (Diopters) 0.002 < 0.001 < 0.001 < 0.001 < 0.001 0.320
Average RNFL (µm) < 0.001 < 0.001 < 0.001 0.05 < 0.001 0.04
Superior RNFL (µm) < 0.001 < 0.001 < 0.001 < 0.001 < 0.001 0.02
Inferior RNFL (µm) < 0.001 < 0.001 < 0.001 < 0.001 < 0.001 < 0.001
Nasal RNFL (µm) 0.65 < 0.001 < 0.001 < 0.001 < 0.001 0.02
Temporal RNFL (µm) < 0.001 < 0.001 < 0.001 < 0.001 < 0.001 0.04

IOP: Intraocular pressure; CCT: Central corneal thickness; LT: Lens thickness; ACD: Anterior chamber depth; RNFL: Retinal nerve fibre layer; M: Month

At baseline, there was no statistically significant difference in the study parameters between the study and control groups [Table 4]. Statistically significant change was noted between the two groups in CCT (P-value = 0.05, 0.04, 0.02), IOP (P-value < 0.001, < 0.001, < 0.001), LT (P-value < 0.001, < 0.001, < 0.001), ACD (P-value = 0.05, 0.03, 0.03), refraction (P value = 0.10, 0.02, 0.02) at 15 days, 1 month, and 3 months follow-up. At baseline, average, superior, and inferior peripapillary RNFL thickness were similar in both groups. However, mean peripapillary RNFL thickness in the temporal and nasal quadrants was found to be significantly thinner in the study group than in controls [Table 5]. Statistically significant increase in peripapillary RNFL thickness was seen between the two groups in the nasal and temporal quadrants at 15 days of follow-up. At 1 month follow-up, a statistically significant increase in peripapillary RNFL thickness was noted in the average, inferior, nasal, and temporal quadrants. At the 3 months follow-up, a statistically significant difference was observed between the two groups only in the inferior quadrant (P = 0.003).

Table 4.

Comparison of Ocular parameters between Topiramate cases versus healthy controls over time

Parameter Baseline. 15 Days 1 Month 3 Months
Refraction (Diopters) Cases -0.20 ± 0.39 -0.30 ± 0.33 -0.36 ± 0.33 -0.37 ± 0.33
Control -0.16 ± 0.49 -0.16 ± 0.49 -0.16 ± 049 -0.17 ± 0.50
P- value 0.69 0.10 0.02 0.02

IOP

(mm Hg)

Cases 13.46 ± 1.71 15.18 ± 2.17 16.27 ± 2.06 18.18 ± 2.48
Control 13.44 ± 1.43 13.39 ± 1.44 13.18 ± 1.91 13.30 ± 1.52
P-value 0.920 < 0.001 < 0.001 < 0.001
CCT (µm) Cases 516.76 ± 34.58 521.98 ± 35.26 522.30 ± 35.36 524.3 ± 36.04
Control 512.74 ± 26.59 512.42 ± 26.29 512.02 ± 26.29 512.33 ± 25.97
P-value 0.410 0.05 0.04 0.02
LT (mm) Cases 3.81 ± 0.33 3.83 ± 0.33 3.85 ± 0.33 3.85 ± 0.33
Control 3.69 ± 0.10 3.67 ± 0.10 3.67 ± 0.11 3.68 ± 0.11
P- value 0.06 < 0.001 < 0.001 < 0.001
ACD (mm) Cases 3.38 ± 0.31 3.35 ± 0.31 3.35 ± 0.30 3.35 ± 0.33
Control 3.44 ± 0.23 3.44 ± 0.23 3.44 ± 0.23 3.43 ± 0.22
P- Value 0.21 0.05 0.03 0.037

IOP: Intraocular pressure; CCT: Central corneal thickness; LT: Lens thickness; ACD: Anterior chamber depth

Table 5.

Comparison of RNFL parameters between Topiramate cases versus healthy controls over time

Parameter RNFL (µm) Time Point Cases (Mean ± SD) Controls (Mean ± SD) P-value
Average Baseline 100.94 ± 15.98 104.05 ± 10.16 0.08
15 days 101.78 ± 16.01 104.45 ± 10.15 0.13
1 month 104.98 ± 16.19 103.26 ± 10.16 0.05
3 months 105.82 ± 16.13 104.56 ± 10.06 0.09
Superior Baseline 131.40 ± 18.79 133.49 ± 16.32 0.45
15 days 132.38 ± 18.61 134.18 ± 17.23 0.53
1 month 136.39 ± 19.24 133.30 ± 16.14 0.27
3 months 136.96 ± 18.90 135.32 ± 16.41 0.56
Inferior Baseline 135.55 ± 19.96 133.00 ± 16.41 0.38
15 days 136.94 ± 19.75 133.20 ± 16.53 0.19
1 month 140.00 ± 19.85 132.14 ± 16.78 0.008
3 months 141.62 ± 20.39 132.89 ± 16.21 0.003
Nasal Baseline 73.35 ± 13.06 78.44 ± 12.40 0.01
15 days 73.26 ± 13.48 78.44 ± 12.49 0.01
1 month 76.35 ± 13.81 80.5 ± 12.64 0.05
3 months 76.94 ± 13.61 79.94 ± 12.54 0.14
Temporal Baseline 63.49 ± 12.10 71.19 ± 12.97 0.0002
15 days 64.45 ± 12.04 71.93 ± 10.97 0.0001
1 month 67.19 ± 11.88 71.04 ± 13.09 0.05
3 months 67.76 ± 11.63 71.03 ± 12.71 0.10

RNFL: Retinal nerve fibre layer

Discussion

Our study aimed to assess the effects of Topiramate therapy on various ocular parameters. The study population predominantly consisted of young adults (mean age: 30.27 ± 4.83 years), with a significant female predominance (87.5%). This aligns with studies by Hesami et al. [10]. and Ozturk et al. [11] who reported a similar demographic profile. Our study shows a higher incidence of females, as our primary indication for treatment initiation was migraine. Female preponderance has been reported due to biological and psychological factors associated with migraine [10].

In our study, migraine was the leading indication for Topiramate use (82.5%), with a smaller proportion of cases involving epilepsy, which was similar to the findings noted by Ozturk et al. [11] and Hesami et al. [10] The mean dose of topiramate in our study was 56 ± 16.6 mg, with most patients receiving a lower dose, reflecting a conservative titration approach. Abdellatif et al. [12]. also prescribed primarily for migraine with a similar mean dose pattern, supporting our findings.

A significant rise in IOP was observed over 3 months (P < 0.001). Bonferroni post hoc analysis confirmed that the rise in IOP was statistically significant at each follow-up interval (P < 0.001), highlighting its progressive nature and the need for further follow-up. These findings align with the studies by Gok et al. [13] and Levy et al. [8], who also reported progressive IOP elevation following Topiramate administration. This study reported elevation of IOP ≥ 22 mm of Hg at the 2 month follow-up. Our patients did not show IOP > 20 mm of Hg, except one patient who presented with acute angle closure with IOP (OD-34 and OS 36 mm of Hg). Our patients showed a sustained elevation of IOP from 15 days to 3 months, indicating progressive IOP elevation, similar to findings by Levy et al. [8] and Orum et al. [14], who observed IOP elevation from 1 week to 2 months.

ACD showed a gradual, statistically significant reduction over the study duration (P < 0.001). Bonferroni post hoc analysis showed that ACD showed a statistically significant reduction with a shallowing plateau effect after 15 days. Gok et al. [13] reported a reduction of ACD at one and two months. However, Thabit et al. [15] found no significant reduction in ACD, which may be due to variations in study populations and measurement techniques. Guier et al. [16] reported a case with raised IOP within 2 weeks of Topiramate therapy along with a shallow anterior chamber. They explained it as an idiosyncratic reaction, leading to supraciliary effusion, causing anterior rotation of the ciliary body, resulting in an anterior shift of the lens, iris-lens diaphragm, leading to shallowing of the anterior chamber depth and thus causing angle closure glaucoma. Our study showed a progressive increase in IOP and a decrease in ACD from 2 weeks, supporting the explanation by Guier et al. [16]

CCT showed a progressive increase from baseline to three months (P < 0.001). This trend is similar to the findings of Hesami et al., [10] who also reported a statistically significant increase in CCT following Topiramate use. Bonferroni analysis confirmed that the increase was statistically significant at all time points compared to baseline (P < 0.001), indicating a sustained effect of the drug on the corneal thickness. LT increased significantly from baseline to three months (P < 0.001). Bonferroni post hoc analysis revealed a significant change in LT from as early as 15 days (P < 0.001), supporting the hypothesis of choroidal effusion-induced lens thickening. Guier et al. [16] proposed that Topiramate causes suprachoroidal fluid accumulation, leading to zonular relaxation and lens thickening.

The myopic shift observed in our study aligns with reports by Ozturk et al. [11] and Gok et al. [13], who documented progressive myopia due to lens and corneal alterations. The mechanism is likely due to osmotic disturbances leading to increased lens thickness and choroidal expansion, as proposed by Gopalkrishna et al. [17]. Bonferroni analysis confirmed that the changes in refractive status were statistically significant at all follow-up points (P < 0.001), supporting the progressive nature of Topiramate-induced myopic shifts. There is a myopic shift in our patients from a 15-day to a 1-month period, evident in post hoc analysis, correlating with increases in LT and CCT and a decrease in ACD.

At baseline, peripapillary RNFL thickness in the nasal and temporal quadrants was found to be significantly thinner in the study eyes than in healthy controls. This might be due to the majority of patients included in the study group having migraine as the diagnosis. It is known that patients with migraine tend to have thinner peripapillary RNFL thickness as compared to healthy subjects. [18] RNFL thickness exhibited a statistically significant increase across all quadrants over 3 months (P < 0.001). Ozturk et al. [11] observed a similar pattern in RNFL thickness except in the temporal quadrant. They suggested that changes in RNFL thickness are due to the presence of carbonic anhydrase enzymes in retinal pigment epithelium and Müller cells, which increase the thickness of the internal limiting membrane of the retina. Bonferroni post hoc analysis confirmed significant increases in RNFL thickness at each follow-up point (P < 0.001), suggesting a sustained and cumulative effect of the drug on retinal structures. However, the long-term implications of this increase in RNFL thickness remain unclear. The present study is short in duration and not powered to assess the long-term effects of topiramate therapy. Randomised studies with larger cohorts and longer follow-up are needed to determine the long-term effects of the drug, if any.

The present study has a few limitations. The sample size is relatively small, and the follow-up period is short. We could not assess anterior segment changes using ultrasound biomicroscopy due to the unavailability of the technology. The dose relation could not be evaluated as maximum patients in our study were prescribed a minimal dose. Baseline characteristics of the two groups might not be similar because the study group included migraine patients, which can independently be associated with thinner RNFL thickness. This has the potential of acting as a confounding factor. Use of both eyes rather than a single eye, might influence independent assumptions.

Conclusion

Our research emphasizes the impact of Topiramate on various ocular parameters over a 3month follow-up period. There was increased IOP, CCT, LT, and RNFL thickness, with myopic shift, and concurrent ACD reduction. Our study provides valuable clinical insights into patients undergoing Topiramate therapy and highlights the importance of regular ophthalmic examination in such patients to detect early ocular changes.

Abbreviations

AACG

Acute angle closure glaucoma

OCT

Optical coherence tomography

IOP

Intraocular pressure

CCT

Central corneal thickness

ACD

Anterior chamber depth

LT

Lens thickness

RNFL

Retinal nerve fibre layer

BCVA

Best-corrected visual acuity

SPSS

Statistical package for social sciences

ANOVA

Analysis of variance

Author contributions

DR MS: concept, design, the definition of intellectual content, literature search, clinical studies, data acquisition, data analysis, statistical analysis, manuscript preparation; DR SM: concept, design, the definition of intellectual content, manuscript preparation, manuscript editing, and manuscript review; DR SP: concept, design, the definition of intellectual content, manuscript preparation, manuscript editing, and manuscript review; DR PKP: concept, design, the definition of intellectual content, manuscript preparation, manuscript editing, and manuscript review.

Funding

Open access funding provided by Siksha 'O' Anusandhan (Deemed To Be University)

Data availability

The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.

Declarations

Ethical approval

The study adhered to the basic tenets of the Helsinki Declaration. Written informed consent was obtained from each of them before enrolling in the study.

Name of the committee

Institutional ethics committee, Institute of Medical Sciences (IMS) and SUM Hospital, Siksha O Anusandhan (deemed to be a university) (ECR/627/Inst/OR/2014)….Letter number IEC/IMS.SH/SOA/2024/851 dated 06/09/2024.

Consent for publication

Not applicable.

Competing interests

The authors declare no competing interests.

Footnotes

Publisher’s note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

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Associated Data

This section collects any data citations, data availability statements, or supplementary materials included in this article.

Data Availability Statement

The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.


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