Giant corneal keloid following Descemet stripping automated endothelial keratoplasty for the treatment of corneal decompensation secondary to trauma.

PURPOSE: This report aims to present a case of corneal keloid caused by chronic corneal insult after trauma and Descemet stripping automated endothelial keratoplasty (DSAEK). CASE PRESENTATION: A 35-year-old male with a history of vision loss in the right eye was referred to our hospital. The patient underwent Ahmed Glaucoma Valve Implantation to alleviate elevated intraocular pressure after ocular trauma to the same eye. One year following the procedure, the eye developed endothelial failure, leading to the performance of Descemet's Stripping Automated Endothelial Keratoplasty (DSAEK) with repositioning of the shunt tube. Upon initial examination, a well-circumscribed elevated white opaque lesion involving the central corneal surface of the RE was observed. Based on the patient's clinical history, slit lamp examination, and UBM findings, the diagnosis of corneal keloid was established. Superficial keratectomy was performed. Histopathological analysis confirmed the diagnosis of corneal keloid. Following the procedure, BCVA improved slightly. However, 3 months later, the patient underwent a penetrating keratoplasty for visual rehabilitation. CONCLUSION: Corneal keloids should be considered following any form of ocular trauma, particularly in cases involving ocular surgery. Diagnosing corneal keloids can sometimes be challenging due to the variety of potential differentials; however, by carefully evaluating the patient's medical history and clinical presentation, we can effectively narrow down the differential diagnosis of corneal conditions.

Corneal and Ocular Surface Contributions From Mexico: A Bibliometric Analysis From 1913 to 2022.

OBJECTIVE: This study aimed to investigate all recorded corneal and ocular surface research by Mexican authors. METHODS: The output data was extracted from SCOPUS to account for all publications regarding the corneal or ocular surface by Mexican authors. Data screening, extraction, and critical revision were performed by two of the authors to avoid duplication and ensure the authenticity of all papers. Performance analysis, science mapping, and network metrics were employed to retrieve trends in publication. RESULTS: A total of 1,091 indexed journal documents by 3965 authors were retrieved, covering the period the period from 1919 to 2022. In performance analysis, the document types included 881 articles, 20 book chapters, 17 conference papers, three editorials, 37 letters to the editor, nine notes, and 123 reviews. A total of 3,965 contributing authors made 6,081 author appearances. In terms of total citations per country, Mexican authors received a total of 7,087 citations, with an average article citation of 8.76 per author. CONCLUSION: This bibliometric analysis highlights impactful research contributions to corneal and ocular surface research from Mexican authors, identifies influential authors and institutions, and also emphasizes the need for increased interaction in the international arena.

Results of Lucia Keratoprosthesis Implantation in Severe Corneal Disease.: Results of Lucia KPro.

PURPOSE: Describe complications, functional success, and retention of the Lucia Keratoprosthesis (KPro). DESIGN: Retrospective interventional case series METHODS: The demographic data, baseline characteristics, complications, functional success, and retention were analyzed for Lucia KPro at Instituto de Oftalmologia Conde de Valenciana in Mexico City from 2021-2023. Multivariate regression analysis and Kaplan-Meier plots were performed to identify associations with functional failure. The main outcome measures were postoperative complications; functional success defined as best-corrected visual acuity (BCVA) ≥ 20/200 (LogMAR 1.0); and device retention rate. RESULTS: Forty-eight eyes of 48 patients (56.88% male) were studied. The mean age at implantation was 57.29 ± 15.63 years (range 27-91) with a mean follow-up of 20.5 ± 8.83 months (range: 3-40). Diagnostic indications for implantation included recurrent graft rejection (54.17%), autoimmune disease (20.83%), chemical injury (12.5%), and other (12.5%). At least one postoperative complication occurred in 75% of patients leading to 65 additional interventions (mean number of subsequent procedures: 1.35 ± 1.3, range 0-5). The preoperative BCVA was 2.40 ± 0.36 LogMAR. At the final follow-up, 62.5% had achieved functional success and 22.92% had a BCVA of 20/40 (LogMAR 0.3) or better. Glaucoma (adjusted OR: 469.74, 95% CI 5.02 - 43939.14, p=0.007) and retinal pathology before KPro (adjusted OR: 372.38, 95% CI 4.18 - 33162.11, p=0.009) were associated with functional failure. The device remained in place in 95.83% of recipients over the follow-up period. CONCLUSION: The Lucia KPro offers functional success in severe corneal diseases and excellent retention in the short to intermediate term.

Mitomycin Intravascular Chemoembolization for Corneal Neovascularization.

PURPOSE: The purpose of the study was to evaluate the efficacy of mitomycin C intravascular chemoembolization (MICE) for corneal neovascularization (CNV). METHODS: This is a prospective, nonrandomized, interventional study. Patients with stable CNV irrespective of the underlying etiology were enrolled in the study. 0.1% mitomycin C was injected intravascularly in CNV at the slit lamp under topical anesthesia. To evaluate the regression of vessels, the ImageJ software was used to trace and quantify vasculature by a pixel count in standardized clinical slit-lamp photographs. RESULTS: Eight eyes from 8 patients with corneal neovascularization and lipid keratopathy were studied. The mean age at treatment was 37 ± 12.75 (range 17-64) years. The median follow-up was 419.5 days (74-1166 days). Herpes simplex keratitis was the main underlying etiology (75%). The visual axis was compromised in 75%, and 100% had stromal scarring. The mean pixel count before MICE was 5983.41 ± 5004.96 pixels. After the treatment, the mean pixel count was 2060.38 ± 3142.96 pixels (delta: 3923.03, P = 0.029). No complications were recorded during the follow-up period. No recurrence of the CNV was observed at the last follow-up. Two eyes (25%) underwent a successful keratoplasty 4 months after MICE. CONCLUSIONS: MICE effectively reduced neovascularization with no immediate safety concerns, though its impact on vision and long-term safety requires further investigation with larger, longer term studies.

Familial fleck corneal dystrophy caused by complete deletion of the PIKFYVE gene.

BACKGROUND: Fleck corneal dystrophy (FCD) is a rare autosomal dominant disease that affects exclusively the corneal stroma. The disease is caused by heterozygous variants in PIKFYVE, a gene encoding a lipid kinase involved in multiple cellular pathways, primarily participating in membrane dynamics and signaling. This report describes a familial case of FCD caused by a complete deletion of the PIKFYVE gene. MATERIAL AND METHODS: A clinical ophthalmic examination was performed on the proband and family members. Genetic testing included next-generation sequencing (multigene panel), and chromosomal microarray analysis. A quantitative PCR assay was designed in order to segregate the deletion. RESULTS: A 19-year-old male, with no family or personal history of ocular disease, presented for evaluation due to an acute illness consisting of burning, foreign body sensation, and red eye. Slit lamp biomicroscopy revealed bilateral small pterygia and scattered bilateral white opacities in the corneal stroma, a very similar corneal phenotype was found in the 47-year-old father, who was asymptomatic. NGS detected a heterozygous deletion of the entire PIKFYVE coding sequence. CMA in DNA from the propositus indicated a 543 kb deletion in 2q33.3q34 spanning the entire PIKFYVE gene. The deletion was confirmed in the father. CONCLUSIONS: We add to the molecular spectrum of FCD by describing a familial case of a whole PIKFYVE gene deletion in affected subjects. Our findings support that normal expression of PIKFYVE is necessary for corneal keratocytes homeostasis and normal corneal appearance. We conclude that PIKFYVE haploinsufficiency is the molecular mechanism underlying this familial case of FCD.

Association between uric acid and referable diabetic retinopathy in patients with type 2 diabetes.

Plasmatic uric acid (UA) has been inconsistently associated with diabetic retinopathy (DR). Specific sight-threatening stages of DR have not been studied for their association with UA. Cross-sectional, comparative study. Between 2014 and 2018 we recruited 210 Mexican individuals > 18 years-old with type 2 diabetes (T2D). Clinical, ophthalmological and biochemical assessment was performed with standardized funduscopic examination. Certified readers classified DR stages. The association between DR and UA was assessed by multiple logistic regression analysis, calculating odds ratios (OR) and 95% CI, after adjustment for covariates. Two hundred and ten patients were included, 41 (19.5%) had referable DR. Subjects with referable (severe or worse) DR had longer diabetes duration, 22 (15-28) vs 15 (8-20) years (P < 0.01); higher levels of UA, 6.5 (5.8-8.1) vs 5.4 (4.5-6.6) mg/dL (P < 0.01); higher systolic blood pressure, 130 (120-140) vs 120 (110-130) mmHg (P < 0.01); higher diastolic blood pressure, 78.4 ± 9.7 vs 75.4 ± 9.2 mmHg (P = 0.03); and lower glomerular filtration rate , 54.1 (41.5-69.6) vs 87.3 (66.8-108.3) mL/min/1.73m2 (P < 0.01) compared with those without referable DR. With multiple logistic regression, after adjustment, per each unit of change (mg/dL) in UA the probability of having referable DR increased 45% (OR = 1.45, 95% CI 1.12-1.87, P < 0.01). When UA was evaluated as dichotomous variable, those with levels ≥ 7.8 mg/dL had almost two times (OR = 2.81, 95% CI 1.00-7.9., P = 0.049) the probability of having referable DR compared with those with levels < 7.8 mg/dL. UA may contribute to the microvascular damage in retinal vessels and therefore hyperuricemia could be a therapeutic target to prevent DR progression.

Neurotrophic keratopathy: General features and new therapies.

Neurotrophic keratopathy is an uncommon degenerative corneal disorder characterized by compromised corneal sensory innervation resulting in the formation of epithelial defects and nonhealing corneal ulcers. Various treatment modalities are available to stabilize disease progression, improve patient well-being, and prevent vision loss. For eligible patients, medical and surgical reinnervation have emerged as pioneering therapies, holding promise for better management. We present a comprehensive review of the disorder, providing an update relevant to ophthalmologists on pathogenesis, diagnosis, treatment options, and novel therapies targeting pathophysiological pathways.

Risk Factors Associated with Diabetic Retinopathy with and without Macular Edema in Recently Diagnosed Patients with Type 2 Diabetes.

Purpose: To evaluate the risk factors associated with diabetic macular edema (DME) in patients with a recent type 2 diabetes mellitus (T2DM) diagnosis. Patients and Methods: We conducted a case-control study at a third-level hospital in Mexico City. We enrolled patients ≥18 years old, with T2DM less than five years of diagnosis, without disabling complications, and non-smokers. The control group was patients with diabetic retinopathy and without macular edema (DR-DME). Cases were patients with DR+DME. We measured fasting glucose, creatinine, lipid profile, urinary albumin/creatinine ratio (ACR), and HbA1c. An ophthalmological examination consisted of visual acuity measurement, digital three-field fundus photography with an automatic non-mydriatic camera, slit lamp, and Optical coherence tomography (OCT) examination. Results: 183 and 61 patients with DR-DME and DR+DME, respectively, were included in the analysis. The prevalence of mild DR was higher in the DR-DME group, but the frequencies of moderate and severe retinopathy were higher in the DR+DME group. Patients in the DR-DME group had better vision than those in the DR+DME group. Logistic regression analysis revealed that age (OR, 1.07), HbA1c (OR, 1.19), and Albumin-to-Creatinine Ratio (ACR) > 30 mg/g (OR, 3.37) were associated with an increased possibility of DME compared to DR-DME. Conclusion: Our study provides insights into the association between risk factors and DME. We found a statistically strong association between HbA1c levels, age, and ACR. Patients with poor metabolic control should undergo an extensive medical examination to screen for DME, which may be related to the chronicity of DM and renal damage.

Importance and use of corneal biomechanics and its diagnostic utility.

The study of corneal biomechanics has become relevant in recent years due to its possible applications in the diagnosis, management, and treatment of various diseases such as glaucoma, keratorefractive surgery and different corneal diseases. The clinical biomechanical investigation has become of great importance in the setting of refractive surgery to identify patients at higher risk of developing iatrogenic ectasia. This review focuses on two of the technologies available for clinical use, the Ocular Response Analyzer (Reichert Ophthalmic Instruments, Buffalo, NY, USA) and the Corvis ST (Oculus Optikgergäte GmbH, Wetzlar, Germany). Both are non-contact tonometers that provided a clinical evaluation of corneal biomechanics. The fundamentals and main parameters of each device are described, as well as their use in eye surgery and the corneal biomechanical behavior in eye diseases. Finally, we will discuss the more recent Brillouin microscopy biomechanical analysis, and the integration Scheimpflug-based corneal tomography and biomechanical data with artificial intelligence to increase accuracy to detect risk of ectasia.

El estudio de la biomecánica corneal ha cobrado relevancia en los últimos años debido a sus posibles aplicaciones en el diagnóstico, el manejo y el tratamiento de diversas enfermedades, como glaucoma, cirugía queratorrefractiva y diferentes enfermedades corneales. La investigación de la biomecánica corneal es de mucha importancia en el contexto de cirugía refractiva, pues podría identificar pacientes en riesgo de desarrollar una ectasia corneal iatrogénica. Esta revisión se centra en dos de las tecnologías disponibles para uso clínico: el Ocular Response Analyzer (Reichert Ophthalmic Instruments, Buffalo, NY, EE. UU.) y el Corvis ST (Oculus Optikgergäte GmbH, Wetzlar, Alemania). Ambos son tonómetros de no contacto que proporcionan una evaluación clínica de la biomecánica corneal. Se describen los fundamentos y los principales parámetros de cada dispositivo, así como su uso en cirugía ocular y el comportamiento biomecánico corneal en las enfermedades oculares. Finalmente, se mencionan los dispositivos más recientes de análisis biomecánico, como la microscopía de Brillouin, así como la integración de los datos biomecánicos y topográficos basados en Scheimpflug con la inteligencia artificial para aumentar la precisión en la detección del riesgo de ectasias.

Cogan syndrome: a case report and review of the literature.

Cogan syndrome is a rare disease whose etiology is still undetermined. It typically affects men and women between the second and fourth decade of life. We report a case of Cogan syndrome with ocular and audio-vestibular involvement as a systemic manifestation in a 31-year-old woman.

Use of Amniotic Membrane Transplant and Deep Anterior Keratoplasty in a Patient with Bilateral Acanthamoeba Infectious Keratitis: A Case Report.

The aim of this study was to report a case with the use of amniotic membrane transplant and deep anterior keratoplasty in a patient with bilateral Acanthamoeba infectious keratitis as a treatment. A 20-year-old male presented with bilateral Acanthamoeba keratitis (AK) who was initially diagnosed with herpetic keratitis receiving full antiviral and corticosteroid topical treatment without any improvement. Corneal biopsy was performed to confirm the suspected diagnosis, and Acanthamoeba stromal cysts were identified in the sample. Treatment was initiated with 0.02% chlorhexidine, 0.1% propamidine isethionate, neomycin, and tropicamide/phenylephrine. Symptoms and clinical improvement were achieved between the 8th and 10th weeks, so corticosteroids were initiated. Treatment was continued until we observed a poor response in the left eye; therefore, an epithelial scraping and amniotic membrane placement were performed. Lately, the right eye underwent a deep anterior lamellar keratoplasty. A challenging case of bilateral AK managed with topical medications, amniotic membrane, and corneal keratoplasty. The earlier the disease is diagnosed, the better the outcome. If the diagnosis is delayed, the amoebas have penetrated deep into the corneal stroma, and successful therapy becomes difficult. A surgical option can be an early solution with a good prognosis for these cases.

Comparison of mini-simple limbal epithelial transplantation and conjunctival-limbal autograft for the treatment of primary pterygium: a randomised controlled trial.

PURPOSE: The purpose of this double-masked, parallel randomised controlled trial was to compare the recurrence rate and other outcomes between conjunctival-limbal autograft (CLAu) and mini-simple limbal epithelial transplantation (mini-SLET) after excision of pterygium. METHODS: Eligibility criteria for participants was the presence of a primary nasal pterygium extending equally to or greater than two millimetres on the cornea on its horizontal axis from the nasal limbus. The participants were allocated into two groups (CLAu and mini-SLET) using simple randomisation with a table of random numbers. Participants and the outcome assessor were masked to the intervention. The study protocol is listed and available on https://clinicaltrials.gov (Identifier: NCT03363282). RESULTS: A total of 61 eyes were enrolled in the study, 33 underwent CLAu (group 1) and 28 mini-SLET (group 2), all eyes were analysed in each group. At 2, 3, 6 and 12 months the CLAu group exhibited a recurrence of 0%, 6.1%, 8.1% and 8.1%, while the mini-SLET exhibited a recurrence of 0%, 17.9%, 50% and 53.5% (p<0.05). There were no intraoperative or postoperative complications in either of the two groups. CONCLUSION: The findings of this study suggest that mini-SLET has a higher recurrence rate and provides no advantage over CLAu in the treatment of primary pterygium.

Ophthalmic findings in patients with autosomal recessive lamellar ichthyosis due to TGM1 mutations in an isolated population.

PURPOSE: To describe the ocular clinical characteristics of a group of Mexican patients with lamellar ichthyosis (LI) arising from TGM1 pathogenic variants. METHODS: Ophthalmological exploration, pedigree analysis and genetic screening were performed in patients with an established clinical diagnosis of lamellar ichthyosis from families located in a small community in the Southeast of Mexico. RESULTS: Nine patients with LI in five families were identified. There were six affected females. All patients (9/9) demonstrated eye lid abnormalities with eight patients showing lid margin abnormalities. Madarosis was present in only three individuals and corneal scarring was documented in two. All nine individuals carried biallelic TGM1 variants, either homozygously or as compound heterozygous. CONCLUSION: Ocular anomalies are common in individuals with TGM1-related LI. The occurrence of a variety of private or rare mutations hampers the identification of a genotype-phenotype correlation for ocular anomalies in this disorder.

Adjuvant Topical Interferon Alpha 2b for the Treatment of Monkeypox Ocular Manifestations.

PURPOSE: The aim of this study was to report a case of ocular Mpox that responded favorably to treatment with topical interferon and oral doxycycline. METHODS: This is a case report of a previously healthy 24-year-old woman who developed a pustular rash, headache, fever, arthralgia, sore throat, and asthenia 3 weeks before attending to our clinic. Her main complaint at the moment of the visit was pain, photophobia, foreign body sensation, blurred vision, red eye, and discharge on the left eye. The slit-lamp examination of the left eye showed severe conjunctival hyperemia associated with tarsal follicles, 360 degrees ciliary injection, diffuse corneal epithelial edema with white linear epithelial infiltrates, pigmented and nonpigmented keratic precipitates, and two 1-mm peripheral corneal ulcers with white infiltrates, associated with positive fluorescein staining. Anterior chamber cellularity and flare were mildly present. RESULTS: Mpox with ocular manifestations diagnosis was confirmed by real-time quantitative reverse transcription polymerase chain reaction assay (qRT-PCR) testing; samples were taken from corneal, conjunctival, and nasopharynx swab as well as a skin scab. Topical interferon alpha 2b 1 MIU/mL every 6 hours for 1 month and oral doxycycline 100 mg BID were administered along with other medications with consequent decrease of inflammation and malaise symptoms 1 week later, associated with uncorrected visual acuity improvement. CONCLUSIONS: Alternative and efficacious treatment options for Mpox ocular manifestations are needed to prevent further disease progression and sequelae in countries with no access to the gold-standard therapy. Topical interferon alpha 2b and oral doxycycline have shown adequate response as shown with this patient.

Visual impairment associated with diabetic retinopathy and macular edema: a hospital-based study.

BACKGROUND: Data on visual impairment (VI) in patients with diabetes are necessary in order to guide economic and human resources for reducing its prevalence. OBJECTIVE: To estimate the prevalence of diabetic retinopathy-related VI in patients with type 2 diabetes in a hospital-based setting. MATERIAL AND METHODS: Cross-sectional study carried out from 2014 to 2019 in an ophthalmology outpatient clinic. Any VI was defined as corrected pin-hole visual acuity in the better eye of ≥ 0.24 logMAR. The presence of diabetic retinopathy (DR), diabetic macular edema (DME) and cataract was evaluated. RESULTS: A total of 840 patients were included; median diabetes duration was 15 years. The prevalence of VI was 30%. DR was found in 62% of patients (30% had sight-threatening DR [STDR]), 17% had referable DME, and 3%, cataracts. The odds ratio for moderate or worse VI was 9.02 for STDR (p < 0.001), 5.89 for referable DME (p = 0.001), and 2.51 for cataract (p = 0.006). CONCLUSION: Thirty percent of participants had some degree of VI. Moderate or worse VI showed a strong association with STDR and referable DME.

ANTECEDENTES: Los datos sobre discapacidad visual (DV) en pacientes con diabetes son necesarios para orientar los recursos económicos y humanos que disminuyan su prevalencia. OBJETIVO: Estimar la prevalencia de DV relacionada con retinopatía diabética en pacientes con diabetes tipo 2 en un entorno hospitalario. MATERIAL Y MÉTODOS: Estudio transversal realizado de 2014 a 2019 en una consulta externa de oftalmología. Cualquier DV se definió como agudeza visual corregida con agujero estenopeico en el ojo con mejor visión (≥ 0.24 logMAR). Se evaluó la presencia de retinopatía diabética, edema macular diabético (EMD) y cataratas. RESULTADOS: Se incluyeron 840 pacientes; la mediana de duración de la diabetes fue de 15 años. La prevalencia de DV fue de 30 %. Se encontró retinopatía diabética en 62 % (30 % tenía retinopatía diabética que amenazaba la visión [RDAV]); 17 %, EMD y 3 %, cataratas. La razón de momios para DV moderada o de mayor gravedad fue de 9.02 para RDAV (p < 0.001), 5.89 para EMD referible (p = 0.001) y 2.51 para catarata (p = 0.006). CONCLUSIÓN: Treinta por ciento de los participantes tenía algún grado de DV. La DV moderada o de mayor gravedad mostró una fuerte asociación con RDAV y EMD referible.

Discapacidad visual asociada a retinopatía diabética y edema macular: un estudio de base hospitalaria / Visual impairment associated with diabetic retinopathy and macular edema: a hospital-based study

Resumen Antecedentes: Los datos sobre discapacidad visual (DV) en pacientes con diabetes son necesarios para orientar los recursos económicos y humanos que disminuyan su prevalencia. Objetivo: Estimar la prevalencia de DV relacionada con retinopatía diabética en pacientes con diabetes tipo 2 en un entorno hospitalario. Material y métodos: Estudio transversal realizado de 2014 a 2019 en una consulta externa de oftalmología. Cualquier DV se definió como agudeza visual corregida con agujero estenopeico en el ojo con mejor visión (≥ 0.24 logMAR). Se evaluó la presencia de retinopatía diabética, edema macular diabético (EMD) y cataratas. Resultados: Se incluyeron 840 pacientes; la mediana de duración de la diabetes fue de 15 años. La prevalencia de DV fue de 30 %. Se encontró retinopatía diabética en 62 % (30 % tenía retinopatía diabética que amenazaba la visión [RDAV]); 17 %, EMD y 3 %, cataratas. La razón de momios para DV moderada o de mayor gravedad fue de 9.02 para RDAV (p < 0.001), 5.89 para EMD referible (p = 0.001) y 2.51 para catarata (p = 0.006). Conclusión: Treinta por ciento de los participantes tenía algún grado de DV. La DV moderada o de mayor gravedad mostró una fuerte asociación con RDAV y EMD referible.

Abstract Background: Data on visual impairment (VI) in patients with diabetes are necessary in order to guide economic and human resources for reducing its prevalence. Objective: To estimate the prevalence of diabetic retinopathy-related VI in patients with type 2 diabetes in a hospital-based setting. Material and methods: Cross-sectional study carried out from 2014 to 2019 in an ophthalmology outpatient clinic. Any VI was defined as corrected pin-hole visual acuity in the better eye of ≥ 0.24 logMAR. The presence of diabetic retinopathy (DR), diabetic macular edema (DME) and cataract was evaluated. Results: A total of 840 patients were included; median diabetes duration was 15 years. The prevalence of VI was 30 %. DR was found in 62 % of patients (30 % had sight-threatening DR [STDR]), 17 % had referable DME, and 3 %, cataracts. The odds ratio for moderate or worse VI was 9.02 for STDR (p < 0.001), 5.89 for referable DME (p = 0.001), and 2.51 for cataract (p = 0.006). Conclusion: Thirty percent of participants had some degree of VI. Moderate or worse VI showed a strong association with STDR and referable DME.

Subconjunctival Sirolimus-Loaded Liposomes for the Treatment of Moderate-to-Severe Dry Eye Disease.

Purpose: To determine the effectiveness of subconjunctival application of a novel sirolimus liposomal formulation for the treatment of dry eye. Methods: A randomized, triple-blind, Phase II clinical trial. Thirty-eight eyes of 19 patients were included. Nine patients (18 eyes) assigned to the sham group (Sham) and 10 patients (20 eyes) to sirolimus-loaded liposomes group (Sirolimus). The treatment group received three doses of subconjunctival liposome-encapsulated sirolimus and the sham group received three doses of liposomal suspension without sirolimus. Subjective (Ocular Surface Disease Index, OSDI) and measured (corrected distance visual acuity, conjunctival hyperemia, tear osmolarity, Schirmer's test, corneal/conjunctival staining and matrix metalloproteinase-9) variables were measured. Results: Sirolimus-entrapped liposomes-treated group OSDI scores changed from 62.19 (± 6.07) to 37.8 (± 17.81) (p=0.0024), and conjunctival hyperemia from 2.0 (± 0.68) to 0.83 (± 0.61) (p<0.0001); Sham group with OSDI scores from 60.02 (± 14.2) to 36.02 (± 20.70) (p=0.01), and conjunctival hyperemia from 1.33 (± 0.68) to 0.94 (± 0.87) (p=0.048). All the other evaluated outcomes only showed significant differences in the sirolimus group: corneal/conjunctival staining score (p=0.0015), lipid layer interferometry (p=0.006), and inferior meibomian gland dropout (p=0.038). No local or systemic adverse effects regarding the medication itself were reported, and the administration route was well accepted. Conclusion: Our findings suggest that sub-conjunctival sirolimus-loaded liposomes are effective in reducing both signs and symptoms of dry eye in patients with poorly controlled moderate-to-severe DED, while avoiding other topical administration adverse effects. Further investigation with a larger sample size is required to determine long-term effects.