Abstract
Purpose
To determine whether gender-affirming hormone therapy (GAHT) influences tear system health in transgender individuals.
Methods
This retrospective cohort observational study analyzed data from transgender men and women ages ≥18-years between 2004 and 2024 via electronic medical record (EMR) data. Following propensity score matching, subjects on hormone therapy included 23,623 transgender men, 15,933 transgender women, and an equal number in each matched control group.
Results
Among transgender men and women, respectively, tear system disorders occurred in 0.90% and 0.94% of those using GAHT and 0.90% and 1.17% of those not using GAHT (p = 0.211, p = 0.072). There was no significant difference in those with documented utilization of GAHT versus no GAHT, for both transgender men and women, respectively, in lacrimal system disorder (p = 0.427, p = 0.292), meibomian gland dysfunction (p = 0.687, p = 0.255), keratoconjunctivitis sicca (p = 0.685, p = 0.576), and combined tear disorders (p = 0.527, p = 0.168).
Conclusions
In this cohort, EMR-documented masculinizing or feminizing GAHT was not associated with an increased incidence of recorded tear-system disorders.
Keywords: dry eye, keratoconjunctivitis sicca, lacrimal system disorders, meibomian gland dysfunction, tear film, transgender adults
Highlights
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Tear system function has been linked to hormones including androgens and estrogens.
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Tear disorders in transgender men treated with masculinizing hormones were similar to controls.
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In transgender women treated with feminizing hormones, tear disorders were similar to controls.
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Gender-affirming hormone therapy did not affect the risk of dry eye and other specific disorders.
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These findings support the ocular safety of gender-affirming hormone therapy.
Introduction
Disorders of the tear system are common, with dry eye disease (DED) affecting an estimated 5 to 16 million Americans, and blepharitis, often present concurrently with DED, impacting up to 14.1 million individuals [1], [2]. The function and regulation of the tear system are linked to circulating sex hormones including androgens and estrogens, demonstrated by the presence of receptors for these sex hormones on the lacrimal and meibomian glands [3]. Androgens, most notably testosterone, play a key role in upregulating meibomian gland secretions to maintain the tear film's lipid component [4]. Several studies suggest that androgen suppression, such as that induced by oral hormonal contraceptives, may contribute to dry eye symptoms in cisgender women of reproductive age [5]. In postmenopausal cisgender women, both high and low estrogen levels have been associated with dry eye disease, further supporting a complex relationship between sex hormones and the ocular tear system [6].
Gender-affirming hormone therapy (GAHT) involves supplemental testosterone for transgender men and supplemental estrogen, with or without antiandrogens, for transgender women to align their bodies more closely with their gender identity [7], [8]. Although GAHT is a well-studied therapy among transgender people, its ocular effects remain largely unknown [9]. Previous studies of sex hormones and the tear system have focused on child-bearing age and postmenopausal cisgender women experiencing DED [1], [5], [9], [10]. While these cisgender-centered studies demonstrate a connection between sex hormones and tear maintenance, there exist very few studies that specifically investigate the association between GAHT for transgender patients and DED and related disorders. This study aimed to investigate the association between the incidence of initiation of GAHT for transgender patients and the incidence of disorders of the tear system.
Methods
This study is retrospective cohort study, utilizing the TriNetX database, which is a global network of healthcare organizations that provides access to electronic medical records (EMR) of over 128 million patients. The data for this study was extracted on July 9th, 2025, and was sourced from a collection of 106 international healthcare organizations as part of the Research Network. De-identified data was analyzed from transgender men and transgender women ages ≥18-years between the years 2004–2024.
TriNetX, LLC complies with the Health Insurance Portability and Accountability Act which is the U.S. federal law that protects the privacy and security of personal healthcare data and data privacy regulations for healthcare organizations. This study used only de-identified patient records and did not collect, use, or transmit any individually identifiable data. In this IRB-approved retrospective study, all patient information was de-identified, and patient consent was not required.
This study compared transgender patients with documented initiation of GAHT in TriNetX with transgender patients who had a diagnosis of gender identity disorder (GID) but no recorded GAHT exposure in TriNetX within the study period. Cohorts were first separated by sex as categorized by TriNetX internal classifications. International Classification of Diseases, 10th revision (ICD-10) codes indicating a prior diagnosis of GID were used to isolate transgender patients from this network [11], [12], [13], [14].
RxNorm and CPT codes that are commonly used for GAHT were isolated for testosterone for masculinizing hormone therapy, as well as estrogens and anti-androgens for feminizing hormone therapy. Additional codes were used to exclude alternate uses of these exogenous sex hormones, narrowing the use of these hormones to gender affirming care (Table 1). Onset of hormone therapy was required to occur after the recorded diagnosis of GID. Additionally, patients were excluded from all groups who had an ocular surface surgery or any tear disorder outcome prior to diagnosis of GID [15], including surgical procedures on the eye and ocular adnexa (1009727), cataract extraction status (Z98.4), disorders of the lacrimal system (H04), meibomian gland dysfunction of eyelid (H02.88), blepharitis (H01.0), chalazion (H00.1) (Table 1). For the intervention groups, transgender men and women with GAHT use, the index event was the start of hormone therapy; for the control groups, the index event was diagnosis of GID.
Table 1.
Cohort Criteria and Outcome Codes.
| Transgender Identification | |
|---|---|
| Transsexualism | ICD-10: F64.0 |
| Gender identity disorder, unspecified | ICD-10: F64.9 |
| Gender identity disorder of childhood | ICD-10: F64.2 |
| Dual role transvestism | ICD-10: F64.1 |
| Other gender identity disorders | ICD-10: F64.8 |
| Transgender Men | |
| Testosterone | RXNORM: 10379 |
| Androgens/anabolics | ATC: HS100 |
| Transgender Women | |
| Estrogens | ATC: G03C |
| Estrogens, esterified (USP) | RXNORM: 214549 |
| Estrogens | RXNORM: 4100 |
| Estrogens | ATC: HS300 |
| Estrogens | ATC: L02AA |
| Antiandrogens | ATC: G03H |
| Antiandrogens, plain | ATC: G03HA |
| Finasteride | RXNORM: 25025 |
| Spironolactone | RXNORM: 9997 |
| Dutasteride | RXNORM: 228790 |
| Flutamide | RXNORM: 4508 |
| Exclusionary Criteria | |
| Surgical procedures on the eye and ocular adnexa | CPT: 1009727 |
| Cataract extraction status | ICD-10: Z98.4 |
| Surgical procedures on the ocular adnexa | CPT: 1009944 |
| Disorders of lacrimal system | ICD-10: H04 |
| Meibomian gland dysfunction of eyelid | ICD-10: H02.88 |
| Blepharitis | ICD-10: H01.0 |
| Chalazion | ICD-10: H00.1 |
| Sjögren syndrome | ICD-10: M35.0 |
| Malignant neoplasm of prostate | ICD-10: C61 |
| Outcomes | |
| Disorders of lacrimal system | ICD-10: H04 |
| Blepharitis | ICD-10: H01.0 |
| Meibomian gland dysfunction of eyelid | ICD-10: H02.88 |
| Chalazion | ICD-10: H00.1 |
| Keratoconjunctivitis sicca, not specified as Sjögren's | ICD-10: H16.22 |
ICD-10: International Statistical Classification of Diseases and Related Health Problems, 10th Revision, 2019, World Health Organization, Geneva, Switzerland.
RXNORM: Normalized names for clinical drugs. U.S. National Library of Medicine, RxNorm, 2025, National Institutes of Health, Bethesda, Maryland.
ATC: Anatomical Therapeutic Chemical Classification, 2025; World Health Organization Collaborating Centre for Drug Statistics Methodology, Geneva, Switzerland.
CPT: Current Procedural Terminology (CPT) 2025 Professional Edition, 2025, American Medical Association, Chicago, Illinois.
Patient cohorts underwent 1:1 propensity score matching for covariates including age, race, overweight/obesity status, and various known comorbidities for dry eye including vitamin A deficiency (E50), nicotine dependence (F17), hyperlipidemia (E78.5), insomnia (G47.0), major depressive disorder, recurrent (F33), diabetes mellitus (E08-E13), glaucoma (H40-H42), systemic lupus erythematosus (M32), essential (primary) hypertension (I10), thyrotoxicosis (hyperthyroidism) (E05), presence of spectacles and contact lenses (Z97.3), atherosclerosis (I70), and taking antidepressants (CN600) [16]. These covariates were isolated with CPT and ICD-10 codes prior to the index event for each cohort and utilized as covariates for matching (Table 2).
Table 2.
Baseline descriptive characteristics of transgender cohorts.
| Transgender Men |
Transgender Women |
|||||
|---|---|---|---|---|---|---|
| GAHT n (%) |
No GAHT n (%) |
p-value | GAHT n (%) |
No GAHT n (%) |
p-value | |
| Total number | 23,672 | 58,357 | – | 16,233 | 34,734 | – |
| Age at index, yrs. ± SD | 22.1 ± 7.6 | 24.3 ± 13.1 | <0.001*** | 27.1 ± 11.1 | 25.7 ± 12.9 | <0.001*** |
| Vitamin A deficiency | 0 (0.0) | 11 (<0.1) | 0.034* | 10 (0.1) | 10 (0) | 0.083 |
| Overweight/obesity | 2542 (10.7) | 4504 (7.8) | <0.001*** | 1414 (8.8) | 2065 (6.0) | <0.001*** |
| Nicotine dependence | 1216 (5.1) | 2028 (3.5) | <0.001*** | 1351 (8.4) | 1795 (5.2) | <0.001*** |
| Hyperlipidemia | 602 (2.5) | 1583 (2.7) | 0.139 | 759 (4.7) | 1018 (3.0) | <0.001*** |
| Insomnia | 1361 (5.8) | 2259 (3.9) | <0.001*** | 806 (5.0) | 988 (2.9) | <0.001*** |
| Major depressive disorder, recurrent |
3736 (15.8) | 5027 (8.7) | <0.001*** | 1912 (11.8) | 1933(5.6) | <0.001*** |
| Diabetes mellitus | 532 (2.2) | 1531 (2.6) | 0.001*** | 569 (3.5) | 997 (2.9) | <0.001*** |
| Glaucoma | 62 (0.3) | 201 (0.3) | 0.053 | 74 (0.5) | 106 (0.3) | <0.001*** |
| Systemic lupus erythematosus |
44 (0.2) | 87 (0.2) | 0.243 | 12 (0.1) | 30 (0.1) | 0.639 |
| Essential (primary) hypertension |
724 (3.1) | 2368 (4.1) | <0.001*** | 1162 (7.2) | 1764 (5.1) | <0.001*** |
| Thyrotoxicosis (hyperthyroidism) |
129 (0.5) | 201 (0.3) | <0.001*** | 56 (0.3) | 64 (0.2) | <0.001*** |
| Presence of spectacles and contact lenses |
77 (0.3) | 191 (0.3) | 0.932 | 45 (0.3) | 64 (0.2) | 0.036* |
| Atherosclerosis | 15 (0.1) | 149 (0.3) | <0.001*** | 34 (0.2) | 89 (0.3) | 0.305 |
| Taking antidepressants | 8589 (36.3) | 13,106 (22.6) | <0.001*** | 4457 (27.6) | 5595 (16.3) | <0.001*** |
GAHT, Gender affirming hormone therapy; SD, standard deviation.
Asterisks indicate statistically significant thresholds: *p < 0.05, **p < 0.01, and ***p < 0.001.
The prevalence of various risk factors for developing disorders of the tear system within 10 years following the index event were assessed for each cohort, allowing ample time for medication-related ocular manifestations to present following GAHT onset [16]. The primary outcomes included the following ICD-10 codes: disorders of the lacrimal system (H04); meibomian gland dysfunction of eyelid (H02.88); and keratoconjunctivitis sicca, not specified as Sjögren's (H16.22). The secondary outcomes included the following associated pathologies: chalazion (H00.1); and blepharitis (H01.0). Outcomes were assessed individually, as combined tear system disorders only, and as combined tear system with associated pathologies, allowing for detailed analyses of the impact of each outcome and summative impact. The incidences of these outcomes were assessed after propensity score matching by Kaplan-Meier analysis comparing the intervention and control groups within each transgender men or women cohorts.
Before matching, baseline characteristics for each group were compared using standardized mean differences. Continuous variables were compared using the non-paired t-test. To assess for significant differences of baseline characteristics between groups, proportions were compared using the Z-test. Propensity score matching was used to balance the cohorts and the baseline characteristics. For outcome comparisons, groups undergoing GAHT were the reference compared with the groups not on GAHT. Outcomes were assessed 1 day after the start of GAHT, or GID diagnosis for those not on hormone therapy, and up to 10 years after. Cohorts were compared using a log-rank test. Statistical analyses were done within the TriNetX platform, including the calculation of hazard ratios (HRs) and their 95% confidence intervals (CI) in a Cox proportional hazards model. Statistical significance was P-value<0.05.
Results
Inclusion criterion yielded 82,029 transgender men and 50,967 transgender women. Among the transgender men, there were 23,672 who utilized testosterone and 58,357 without testosterone. Among the transgender women, there were 16,233 who utilized both estrogens and antiandrogens, and 34,734 without these hormones.
Before matching, there were significant differences between transgender men with and without GAHT use in age at index (22.1vs24.3 years, respectively, p < 0.001) and in the rates of overweight/obesity (10.7%vs7.8%,p < 0.001), nicotine dependence (5.1%vs3.5%,p < 0.001), insomnia (5.8%vs3.9%,p < 0.001), major depressive disorder (15.8%vs8.7%,p < 0.001), diabetes mellitus (2.2%vs2.6%,p = 0.001), essential hypertension (3.1%vs4.1%,p < 0.001), thyrotoxicosis (0.5%vs0.3%,p < 0.001), atherosclerosis (0.1%vs0.3%,p < 0.001), and antidepressant use (36.3%vs22.6%,p < 0.001) (Table 2).
Comparing transgender women with and without GAHT use, there were significant differences in age at index (27.1vs25.7 years, respectively, p < 0.001) and in the rates of overweight/obesity (8.8%vs6.0%,p < 0.001), nicotine dependence (8.4%vs5.2%,p < 0.001), hyperlipidemia (4.7%vs3.0%,p < 0.001), insomnia (5.0%vs2.9%,p < 0.001), major depressive disorder (11.8%vs5.6%,p < 0.001), diabetes mellitus (3.5%vs2.9%,p < 0.001), glaucoma (0.5%vs0.3%,p = 0.008), essential hypertension (7.2%vs5.1%,p < 0.001), thyrotoxicosis (0.3%vs0.2%,p = 0.001), presence of spectacles and contact lenses (0.3%vs0.2%,p = 0.036), and antidepressant use (27.6%vs16.3%,p < 0.001) (Table 2).
Following propensity score matching, 23,623 transgender men and 15,933 transgender women were isolated for analysis in each respective hormone therapy cohort, with an equal number in the corresponding matched control groups. There was a loss of 49 transgender men and 300 transgender women from analysis following propensity score matching because no adequately matched counterparts were available. Among transgender men, there was no difference between cohorts for all outcomes including lacrimal system disorder (0.65%vs0.67%,p = 0.427), meibomian gland dysfunction (0.14%vs0.10%,p = 0.687), or keratoconjunctivitis sicca not specified as Sjogren's (<0.01%vs < 0.01%,p = 0.685). Additionally, there was no difference between the intervention or control groups for combined tear disorders only (0.75%vs0.72%,p = 0.527) and combined tear disorders with associated pathologies (0.90%vs0.90%,p = 0.425) (Table 3).
Table 3.
Hazard ratio of individual and collated outcomes between propensity score-matched cohorts.
| Group | Patients in Cohort | Patients with diagnosis, n (%) | Hazard ratio (95% CI) | p-value | ||
|---|---|---|---|---|---|---|
| Lacrimal system disorder | Transgender men | GAHT | 23,623 | 154 (0.65) | 0.854 (0.684–1.066) | 0.427 |
| No GAHT | 23,623 | 159 (0.67) | ||||
| Transgender women | GAHT | 15,933 | 107 (0.67) | 0.817 (0.633–1.055) | 0.292 | |
| No GAHT | 15,933 | 135 (0.85) | ||||
| Meibomian gland dysfunction | Transgender men | GAHT | 23,623 | 34 (0.14) | 1.328 (0.777–2.271) | 0.687 |
| No GAHT | 23,623 | 22 (0.10) | ||||
| Transgender women | GAHT | 15,933 | 27 (0.17) | 1.199 (0.690–2.085) | 0.255 | |
| No GAHT | 15,933 | 24 (0.15) | ||||
| Keratoconjunctivitis Sicca | Transgender men | GAHT | 23,623 | ≤10a | 0.851 (0.275–2.640) | 0.685 |
| No GAHT | 23,623 | ≤10a | ||||
| Transgender women | GAHT | 15,933 | ≤10a | 0.486 (0.121–1.949) | 0.576 | |
| No GAHT | 15,933 | ≤10a | ||||
| Blepharitis | Transgender men | GAHT | 23,623 | 36 (0.15) | 0.928 (0.582–1.479) | 0.621 |
| No GAHT | 23,623 | 35 (0.15) | ||||
| Transgender women | GAHT | 15,933 | 28 (0.18) | 1.153 (0.670–1.984) | 0.411 | |
| No GAHT | 15,933 | 25 (0.16) | ||||
| Chalazion | Transgender men | GAHT | 23,623 | 20 (0.09) | 0.879 (0.473–1.636) | 0.697 |
| No GAHT | 23,623 | 20 (0.09) | ||||
| Transgender women | GAHT | 15,933 | 14 (0.09) | 0.877 (0.427–1.804) | 0.895 | |
| No GAHT | 15,933 | 16 (0.10) | ||||
| Combined tear system disorders onlyb | Transgender men | GAHT | 23,623 | 176 (0.75) | 0.904 (0.732–1.117) | 0.527 |
| No GAHT | 23,623 | 171 (0.72) | ||||
| Transgender women | GAHT | 15,933 | 122 (0.77) | 0.831 (0.654–1.057) | 0.168 | |
| No GAHT | 15,933 | 151 (0.95) | ||||
| Combined tear system disorders + associated pathologiesc | Transgender men | GAHT | 23,623 | 213 (0.90) | 0.885 (0.732–1.071) | 0.425 |
| No GAHT | 23,623 | 212 (0.90) | ||||
| Transgender women | GAHT | 15,933 | 149 (0.94) | 0.820 (0.660–1.018) | 0.088 | |
| No GAHT | 15,933 | 186 (1.17) | ||||
GAHT: Gender affirming hormone therapy; CI, confidence interval.
TriNetX reports 10 as their minimum number of outcomes for patient privacy.
Includes: Lacrimal system disorders, meibomian gland dysfunction, keratoconjunctivitis sicca.
Includes: Lacrimal system disorders, meibomian gland dysfunction, keratoconjunctivitis sicca, blepharitis, chalazion.
Similarly, among transgender women, there was no difference between the groups for all outcomes including lacrimal system disorder (0.67%vs0.85%, p = 0.292), meibomian gland dysfunction (0.17%vs0.15%,p = 0.255), keratoconjunctivitis sicca not specified as Sjogren's (<0.01%vs < 0.01%,p = 0.576), and combined tear system disorders only (0.77%vs0.95%,p = 0.168) (Table 3). There was also no difference between interventional and control groups for combined tear system disorders with associated pathologies, (0.94%vs1.17%,p = 0.088), with a hazard ratio of 0.82 (95% CI,0.660–1.018).
Discussion
This study investigated the impact of GAHT on the incidence of disorders of the tear system in a large-scale transgender population. In this study, we quantified the effects of feminizing or masculinizing GAHT on tear film parameters in comparison to transgender patients without documented GAHT exposure in TriNetX during the study window. We found no significant association of GAHT and EMR-documented dry eye or other ocular tear film abnormalities.
Prior to propensity score matching, there were significant differences in demographics and comorbidities between the intervention and control groups. Transgender men and women on GAHT tended to have higher rates of depression, nicotine dependance, insomnia, obesity, and antidepressant use. Those who initiate hormone therapy may represent a subset with more severe gender dysphoria or psychological distress, which has been associated with higher baseline rates of depression and substance use disorders compared to those who do not pursue medical transition, reflecting the unmet care needs and minority stress of this population [17], [18]. While these findings are statistically significant, most of the demographics and comorbidities are low prevalence in relation to the entire cohort size. This may reflect the relatively young average age of patients in this study, including subjects who have yet to develop these conditions, or may be a direct manifestation of social barriers that transgender individuals are known to face in accessing healthcare [9], [19], [20].
After the adjustments for confounders, there was no difference in incidence of tear system disorders or associated pathologies between those on GAHT and those not on GAHT among both transgender men and transgender women groups. This finding was unexpected, given prior evidence supporting a protective effect of testosterone against dry eye and the higher prevalence of dry eye symptoms reported in cisgender women using hormonal contraceptives [6].
One possible explanation for this finding is the route of hormone administration (ROA). Transgender women primarily utilize transdermal estradiol (43%) and intramuscular injections (31%), while transgender men almost exclusively utilize intramuscular or subcutaneous testosterone injections [21], [22]. Alternatively, cisgender women most commonly use the oral form of hormonal contraceptives, accounting for over 50% among those on hormonal contraception [23]. Compared to oral formulations, transdermal and injectable routes typically maintain more stable serum hormone levels over time [24], which may reduce hormonal fluctuations associated with tear film instability [25], [26].
These differences in route of administration may account for the observed lack of increased risk of tear system disorders in transgender individuals on GAHT. However, ROA data for the patients on GAHT was not accessible for analysis, so further investigation regarding various effects of each ROA with serial serum hormone levels would clarify if delivery method influences the risk of tear disorders.
This study has several strengths, including a larger cohort size than many transgender-focused studies with small sample sizes [6], [27], allowing evaluation of underreported tear-system outcomes. Furthermore, matching on measured baseline characteristics helped reduce observed differences between cohorts and supported more balanced comparisons.
Limitations of this study included the use of EMR-based data, which may under-capture the true prevalence of tear-system disease and lacks objective lacrimal function testing. Patients with more severe cases of dry eyes are expected to be more likely to seek medical attention [28], [29], suggesting that clinically meaningful cases may still be represented [13]. ICD-10 codes and medication records may also lead to misclassification based on GAHT exposure or patient identity. Although requiring documented masculinizing therapy in recorded females and feminizing therapy in recorded males was intended to make hormone exposure specific to GAHT purposes, it does not eliminate the risk of misclassification, and patients may even receive therapy outside of participating healthcare organizations [30].
Additional limitations include imprecise GAHT exposure tracking, including the inability to assess hormone therapy duration, consistency, or route of administration. Finally, exposed patients were indexed at GAHT initiation, whereas controls were indexed at GID diagnosis, creating possible time-zero bias not fully addressed by matching.
Conclusion
In summary, this study found no association between documented GAHT and increased risk of tear disorders such as keratoconjunctivitis sicca, lacrimal gland dysfunction, or meibomian gland disease. These findings provide reassurance for transgender people considering masculinizing or feminizing hormone therapy, while also highlighting the need for future studies with more detailed hormone exposure data and objective tear-function testing. Overall, this study adds to the limited ophthalmic literature on GAHT, offering insight into the broader ocular safety profile of hormone therapy in transgender care.
CRediT authorship contribution statement
Keith E. Arnold: Writing – review & editing, Writing – original draft, Software, Resources, Methodology, Funding acquisition, Formal analysis. Michael J. Foster: Writing – review & editing, Software, Methodology, Formal analysis. Tomasz A. Tabernacki: Writing – review & editing, Software, Methodology, Formal analysis. Chase A. Turner: Writing – review & editing, Software, Methodology, Formal analysis. Peter A. Netland: Writing – review & editing, Supervision, Resources, Project administration, Funding acquisition, Formal analysis. Kirtishri Mishra: Writing – review & editing, Supervision, Project administration, Formal analysis.
Ethics statement
Case Western Reserve University waived the need for ethics approval and patient consent for the collection, analysis and publication of the retrospectively obtained and anonymized data for this non-interventional study. The study received ethical approval from the Case Western Reserve University Institutional Review Board IRB.
Funding
Medical students were supported by the Ray A. and Robert L. Kroc Summer Research Fellowship and Award. This Summer Research program was supported by the Clinical and Translational Science Collaborative of Northern Ohio. This project was supported by the Clinical and Translational Science Collaborative of Northern Ohio, which is funded by the National Institutes of Health, National Center for Advancing Translational Sciences, Clinical and Translational Science Award grant, UM1TR004528. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.
Declaration of competing interest
The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
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