Ocular Effects of Topical and Systemic Steroids
Steroids are invaluable agents in the treatment of a diverse spectrum of disorders; however, their use is not without risks. Topical, periocular, and systemic steroids may cause ocular complications, including cataracts, glaucoma, opportunistic infections of the eye, and delayed corneal healing. Less common ocular sequelae of steroids include exophthalmos; ocular muscle palsy; blue sclerae in children; refractive changes; pseudotumor cerebri; hypertensive retinopathy; and ptosis, chemosis, and lid swelling associated with moon fades. The prevention of ocular complications due to steroids is best managed by an ophthalmologist through routine examinations and intraocular pressure measurements.
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Association between systemic medication use and severity of dry eye signs and symptoms in the DRy eye assessment and management (DREAM) study
2024, Ocular SurfaceSome systemic medications are reported to be associated with dry eye disease (DED), yet their associations with the severity of DED signs and symptoms are not well studied. To evaluate these associations, we performed a secondary analysis of data from the DRy Eye Assessment and Management (DREAM) Study.
Participants (N = 535) were assessed for DED signs using tear break-up time (TBUT), Schirmer testing, corneal fluorescein staining, conjunctival lissamine green staining, meibomian gland dysfunction (MGD), and tear osmolarity and DED symptoms using the Ocular Surface Disease Index (OSDI). We derived a composite signs severity score from the 6 DED signs and categorized participant-reported systemic medications into antidepressants, antihistamines, aspirin, corticosteroids, diuretics, nonsteroidal anti-inflammatory drugs, proton pump inhibitors, statins, vitamin D3, and medications for diabetes mellitus, hypertension, hypothyroidism, migraine, and seizure. Generalized linear models were used to compare DED symptom and sign scores between medication users and non-users, with adjustment for factors associated with DED severity.
Compared to non-users, antihistamine users had lower TBUT (p = 0.01) and higher OSDI score (p = 0.02); aspirin users had lower TBUT (p = 0.02); corticosteroid users had lower TBUT (p = 0.02), lower Schirmer test scores (p = 0.03), higher cornea fluorescein staining (p = 0.01), higher composite severity score (p = 0.01), and higher OSDI score (p = 0.03); seizure medication users had higher composite severity score (p = 0.02); vitamin D3 users had lower TBUT (p = 0.001) and greater MGD (p = 0.03); and diuretic users had less MGD (p = 0.03).
Certain systemic medications may be associated with more severe DED. This may guide prescription practices in patients with DED.
Next generation therapeutics for retinal neurodegenerative diseases
2024, Journal of Controlled ReleaseNeurodegenerative diseases affecting the visual system encompass glaucoma, macular degeneration, retinopathies, and inherited genetic disorders such as retinitis pigmentosa. These ocular pathologies pose a serious burden of visual impairment and blindness worldwide. Current treatment modalities include small molecule drugs, biologics, or gene therapies, most of which are administered topically as eye drops or as injectables. However, the topical route of administration faces challenges in effectively reaching the posterior segment and achieving desired concentrations at the target site, while injections and implants risk severe complications, such as retinal detachment and endophthalmitis. This necessitates the development of innovative therapeutic strategies that can prolong drug release, deliver effective concentrations to the back of the eye with minimal systemic exposure, and improve patient compliance and safety. In this review, we introduce retinal degenerative diseases, followed by a discussion of the existing clinical standard of care. We then delve into detail about drug and gene delivery systems currently in preclinical and clinical development, including formulation and delivery advantages/drawbacks, with a special emphasis on potential for clinical translation.
Long-Term Follow-up of Patients With Uveitis Treated With Adalimumab: Response Rates and Reasons for Discontinuation of Therapy
2022, American Journal of OphthalmologyTo evaluate the effectiveness and reasons for discontinuation including the side effect profiles of adalimumab in a real-world setting.
Retrospective clinical cohort study.
A medical chart review of clinical practice in 2 tertiary eye care services in Rotterdam, the Netherlands, was performed Data were collected from May 1, 2004, through September 1, 2020. Patients with noninfectious uveitis treated with adalimumab (n = 341; 633 affected eyes) were included. The primary outcome was the effectiveness of adalimumab, measured by the number of patients achieving inactive disease, remission, and relapse-free survival. The secondary outcomes were the reasons for discontinuation, including side effects, and the number of patients who developed antibodies.
In total, 341 patients were treated with adalimumab between May 2004 and September 2020. The uveitis recurrence-free survival interval was 3.4 years (range, 0-13 years). Adalimumab had an acceptable side effect profile. A total of 178 patients achieved inactive disease while continuing adalimumab, and 51 patients maintained remission after discontinuing adalimumab. Reasons for discontinuation of adalimumab were no response, relapse, or reasons unrelated to the effectiveness of treatment. Adalimumab antibodies were present in 40 of 115 patients (35%). Antibodies were associated with lower adalimumab levels, and antibodies were observed more often in patients on adalimumab monotherapy (P < .01).
Adalimumab is effective for patients with noninfectious uveitis, with an acceptable side effect profile. Although relapses can occur, the majority of the patients achieved inactive disease or remission after cessation of adalimumab, without other systemic immunosuppressive medication.
A randomized clinical trial of triamcinolone acetonide injection for suppression of inflammation after blepharoptosis surgery
2022, Journal of Plastic, Reconstructive and Aesthetic SurgeryCitation Excerpt :This was also probably because we used the minimum dose, and the site of the injection was relatively far from the globe of the eye.20 Atrophy, infection, and skin depigmentation are also reported, but were not identified in our series.32, 33 Despite these concerns, our series was free of complications and our protocol was safe in this early period.
This study aimed to determine the effectiveness of triamcinolone acetonide in suppressing inflammation after blepharoptosis surgery. The study was designed as prospective, randomized, two medical centers’ clinical trial. Thirty-two patients with involutional blepharoptosis of the same degree in both eyelids underwent bilateral transcutaneous levator advancement. At the end of the surgery, 4 mg/0.1 ml of triamcinolone acetonide was injected into a randomly selected upper eyelid. The fellow eyelid was not injected and was used as control. Facial photographs were taken on day 1, week 1, month 1, and month 3, and the degree of inflammation, the margin reflex distance 1 (MRD-1), and levator function (LF) between the two eyelids of each patient were compared. The primary outcome was the selection of the less inflamed eyelid decided by the majority of three individuals unrelated to the study. MRD-1 and LF were analyzed for secondary outcomes. As a result, the injected eyelid was judged to be the less inflamed eyelid in all cases. The MRD-1 in the postoperative period less than 1 month was significantly larger in the injected eyelids than the control eyelids (P<0.03). The postsurgical MRD-1 at month 3, the postsurgical LF at all postsurgical examination times were not statistically different. Adverse complications by the injection, including ptosis, levator dysfunction, increase of the intraocular pressure, and visual disturbance were not observed. In conclusion, a triamcinolone acetonide injection after ptosis surgery is both safe and effective in reducing the early postsurgical inflammation and helpful in an earlier return to a daily routine for the patients.
Down regulation of inflammatory cytokines by the bioactive resveratrol-loaded chitoniosomes in induced ocular inflammation model
2021, Journal of Drug Delivery Science and TechnologyResveratrol (RSV); a natural polyphenol possess anti-inflammatory property through reduction of proinflammatory cytokines tumor-necrosis factor-alpha (TNFα) and interleukin (IL)-6 which play a key role in eye inflammation. Ocular inflammation results in irreversible tissues damage and impaired vision if left untreated. Surface coating of niosomes with chitosan can enhance their efficacy. Therefore the aim was to develop RSV-loaded chitosan-coated niosomes (Chitoniosomes) for topical ocular delivery. Chitoniosomes were formulated by ethanol-injection method. The selected formula (RSV.CsNiPolx) was composed of Span 60, Poloxamer407 and Cholesterol (3.5:3.5:3) coated with 0.6% w/v Chitosan. RSV.CsNiPolx showed particle size 363.1nm, PDI (0.21), zeta potential (+17.9), 90.3% entrapment efficiency, mucoadhesive efficiency with a sustained-release profile (56%) after 6 h. TEM showed circular shape niosomes surrounded by a relatively faded coat. The formula kept stable at 4 °C for 6 months storage. Good ocular tolerance of Chitoniosomes formulation without any inflammatory response to the rabbit eyes was confirmed by histological examination. Invivo antiinflammatory effects after 3 days treatment revealed reduced gene expressions of TNFα and IL-6, down to 49% and 55% respectively, in treated groups compared to control group. In conclusion, the results offer a promising nanoplatforms for topical application of the natural bioactive resveratrol in ocular inflammation.
Phase 3 Randomized Study of Efficacy and Safety of a Dexamethasone Intracanalicular Insert in Patients With Allergic Conjunctivitis
2021, American Journal of OphthalmologyThe purpose of this study was to evaluate the efficacy and safety of a dexamethasone intracanalicular ocular insert for the treatment of allergic conjunctivitis.
Multicenter, randomized, double-masked, placebo-controlled, Phase 3 clinical trial.
Subjects with allergic conjunctivitis were randomized 1:1 to receive a dexamethasone insert or a placebo insert in both eyes and were evaluated using a modified version of the conjunctival allergen challenge (CAC) model. After inserts were placed in office, a series of 4 closely spaced post-insertion CACs were conducted at weeks 1, 2, and 4 across approximately 30 days. Primary efficacy endpoints, assessed at week-1 CAC-day 8, were reported by subjects of ocular itching at 3, 5, and 7 minutes post CAC and investigator-evaluated conjunctival redness at 7, 15, and 20 minutes post CAC.
For the primary endpoints, dexamethasone inserts showed statistically significantly lower mean ocular itching scores than placebo at all time points (P <.001), with differences favoring dexamethasone inserts over placebo (0.86, 0.98, and 0.96 units at 3, 5, and 7 minutes, respectively) and statistically significantly lower conjunctival redness scores at 20 minutes (P <.05) but not at 7 or 15 minutes (P ≥.05). Results also showed statistically significantly less itching and conjunctival redness at 31 and 29 of 33 other time points, respectively (P <.05). There were no serious adverse events; 1 subject had elevated intraocular pressure in both eyes.
Data presented in this study demonstrate the potential for a single, physician-administered dexamethasone intracanalicular insert to provide relief of ocular itching for up to 4 weeks in subjects with allergic conjunctivitis, while maintaining a favorable safety profile.