Scleritis
Scleritis is a serious inflammatory condition affecting the white outer layer of the eye. Explore research studies for Scleritis near you.
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Found 12 Actively Recruiting clinical trials
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Healthy Volunteer
The primary efficacy endpoints are the standard deviation and coefficient of determination (R2) between predicted and actual values for the bilirubin regression model, and the grading accuracy for the jaundice severity classification model. The secondary efficacy endpoint is the mean percentage error between predicted and actual bilirubin values. There are no relevant safety risks. Statistical differences for categorical variables (e.g., jaundice grading evaluation indicators) will be analyzed using the chi-square test or Fisher's exact probability test. For continuous variables (e.g., bilirubin prediction evaluation indicators), t-tests (normal distribution) or non-parametric tests (non-normal distribution) will be used. The 95% confidence interval for jaundice grading accuracy will be calculated using the Wilson method. The study duration is estimated to be 3 months.
RECRUITING
BACKGROUNDS Nowadays, phacoemulsification for cataract treatment is the most common surgical procedure performed and anesthetics procedure has been shifted from retrobulbar or peribulbar anesthesia to topical anesthesia (TA). Phacoemulsification under TA proved to be a safe and low risk procedure with the incidence of adverse events requiring medical emergency team interventions to be 0.04%. However, it is not uncommon that patients can suffer from pain, anxiety and unpleasant visual sensation during this procedure. Complementary sedation has long been thought to alleviate the anxiety and pain of the patient during surgery with local anesthesia. Studies revealed that approximately one fourth of the patients underwent phacoemulsification under TA or retrobulbar anesthesia requested additional intravenous sedation of midazolam. \[8\] However, the intravenous sedation, such as midazolam, propofol, or etomidate, increase the risk of additional anesthetic complications of heart rate, blood pressure, body temperature, and nausea, \[9,10\] and therefore, anesthesia monitoring was mandatory during the surgery. Compared with intravenous sedation, oral sedation is less costly and less invasive. Studies with different oral sedation agents revealed different effects. In the study of 41 patients serving themselves as control, patients reported more pain and photophobia in the surgery with TA alone than the other with midazolam syrup and oral transmucosal fentanyl citrate. However, two studies comparing oral diazepam or triazolam with intravenous midazolam showed similar rates of anxiety and pain or noninferior satisfaction. Moreover, the randomized control trial containing 50 procedures in each groups revealed that patients received TA alone during phacoemulsification reported similar pain or anxiety level to those received complementary intravenous midazolam. Despite the abundant results from above, nearly 40% patients reported moderate to extremely anxiety during phacoemulsification under TA, and approximate 7% of patients rated themselves extreme anxiety or were diagnosed as anxiety. A simple comparison between with or without complementary sedation for general patients underwent phacoemulsification with TA is merely not enough. Further investigations to reduce the anxiety experienced during phacoemulsification with TA according to patients' characteristics is therefore mandatory. Previous studies had showed that patients with higher level of trait anxiety reported higher anxiety response for a stressful situation. Preoperative anxiety levels were also reported to be a significant predictor of pain experience during phacoemulsification with TA. The need for complementary sedation could be different in patients with different trait anxiety. Furthermore, different severity levels of anxiety and pain were experienced during the first and second eye surgery. Therefore, in this study, the investigators will investigate the trait anxiety of patients planned for phacoemulsification under TA and its effect on their anesthetic satisfaction with complementary oral sedation. The investigators will also analysis the anxiety and pain experienced in the first and second eye phacoemulsification in patients with different levels of trait anxiety. The investigators choose alprazolam as the oral sedative. It was reported to have a shorter half-life and less side effects of drowsiness and lightheadedness than diazepam used in previous studies.
RECRUITING
In the diagnostic approach of patients with ophthalmologic diseases, as well as for surgical purposes, the administration of mydriatic and cycloplegic drugs is indispensable. Among these, the combination of tropicamide and phenylephrine (TF) is commonly used. Studies evaluating the topical ocular administration of these medications have demonstrated an adequate risk-benefit balance; however, certain local and systemic safety aspects remain insufficiently evaluated. Justification: This study will help identify the at-risk population (clinical determinants) prior to the administration of drugs such as TF, provide additional information regarding the safety profile of this drug at the 8 mg/50 mg/mL concentration, and propose measures to reduce the occurrence of adverse drug reactions (ADRs) in at-risk populations. It also aims to develop safety barriers that allow for safer administration of the medication. Moreover, this research provides a first approximation and establishes the basis for future studies that may compare different TF concentrations. Hypothesis: There will be a positive association between clinical determinants and the occurrence of adverse drug reactions. Research Question: Is there an association between the clinical determinants of hospitalized patients and the occurrence of adverse drug reactions following the administration of tropicamide/phenylephrine? Objective: To evaluate the association between clinical determinants and the occurrence of adverse drug reactions in hospitalized patients who received tropicamide/phenylephrine 8 mg/50 mg/mL. Materials and Methods: An ambispective study will be conducted to identify ADRs associated with TF administration, as well as to characterize pathologies that may predispose patients to ADRs (clinical determinants, CD), through the use of a questionnaire, with the purpose of establishing an association between them. Data Analysis: Results will be analyzed using the Chi-square test for qualitative variables and the calculation of odds ratios (OR) with 95% confidence intervals. Quantitative variables will be analyzed using the Student's t-test for normally distributed data, or the Wilcoxon signed-rank test for data not normally distributed. Normality will be assessed with the Kolmogorov-Smirnov test (p \> 0.05). The association between CDs and ADRs will be evaluated through logistic regression analysis
RECRUITING
Healthy Volunteer
Background: Increasing demand for hospital eyecare and limited resources makes improved uptake of remote consultation essential. Unsupported workflows and the lack of an accurate visual acuity (VA) assessment are recognised factors limiting its uptake by ophthalmologists. Difficulties with accessing and trusting technology are widely reported barriers for patients. A novel implementation model of remote consultation with vision selftesting (using the DigiVis app in this study) which is co-designed with stakeholders could support and promote its use. Methods: This mixed methodology, highly pragmatic study will take place in three large NHS eye departments (in Cambridge, Peterborough and Manchester) with high levels of age, ethnic, cultural and socio-economic diversity. Qualitative and quantitative data from semi-structured interviews, ethnographic field notes in the community and the Planning and Evaluating Remote Consultation Services (PERCS) framework in hospital-based patient and staff focus groups will identify implementation challenges. An implementation model to mitigate these challenges will be co-designed with stakeholders and put into operation. Patients will be allocated to the intervention pathway at their clinician's discretion and with their implied agreement in accepting the appointment. Implementation and service outcomes will be assessed using the Practical, Robust, Implementation and Sustainability Model of the Reach Effectiveness Adoption Implementation Maintenance (PRISM RE-AIM) framework before, during and after 14 months of operation, enabling adaptation of the model. Online questionnaires of approximately 100 patients assigned to the intervention by their clinician, will enable quantitative analysis of change in patients' perceived attributes of the e-health innovation scores before and after its use. Online questionnaires will enable quantitative changes in the Normalisation Process (NoMAD) scores of approximately 100 staff before and after implementation of the co-deisgned model to be analysed by descriptive statistics. The optimised implementation model for the intervention, when scaled up, could reach over 3 million patients a year and alleviate some of the pressures on United Kingdom (UK) ophthalmology services. Dissemination of the model and toolkit via websites, publications and presentations to patients, clinicians, service managers and policy makers will supportthe adoption of remote consultations using self-assessment apps, like DigiVis. This could not only improve patient care in the NHS but improve access to eyecare and vision screening for rural communities internationally.
RECRUITING
There are more than 100,000 eye prosthesis wearers in France. Half of these patients are bothered by secretions or sandy sensations, or even chronic pain. Various anti-inflammatory treatments are proposed without scientific basis. A pilot study on a limited number of patients conducted in 2017 at the University Hospital of Rennes and published in 2019 showed the interest of Dexamethasone eye drops in these patients. However, this study was retrospective and not controlled. We therefore wish to propose a prospective, placebo-controlled, single-blind clinical study to define the value of anti-inflammatory treatment in patients with ocular prostheses. We propose to evaluate the efficacy of treatment with Hydrocortisone and Dexamethasone (in a cross-over design) in patients with ocular prostheses and significant functional discomfort.
RECRUITING
Topical steroids are the current standard of care for managing postoperative pain and inflammation following vitreoretinal surgery. However, topical treatments are limited by the potential for patient non-adherence and variation in drug concentrations due to the intermittent nature of application. A corticosteroid insert, placed following surgery, provides the advantages of reliable and continuous drug delivery without the need for patients to adhere to a treatment regimen. Recently, DEXTENZA®, a dexamethasone intracanalicular insert was FDA-approved for the treatment of inflammation and pain following ophthalmic surgery. DEXTENZA® is placed into the canaliculus via the lower punctum and is designed to release steroid medication for 30 days. The data is limited regarding the safety and efficacy of DEXTENZA® for postoperative management of vitreoretinal surgery. Herein, the aim of this study is to assess the management of pain and inflammation following retinal surgery when using a dexamethasone implant compared with topical steroids.
RECRUITING
Healthy Volunteer
This study employs a two-arm randomized controlled trial to evaluate whether artificial intelligence (AI)-generated plain language summaries (PLSs) can improve patient comprehension of ophthalmology notes. Eligible participants are recruited during their routine visits at the Jules Stein Eye Institute, and once screened using standardized clinical criteria, they are randomly assigned to either receive the standard ophthalmology note (SON) or the SON supplemented with an AI-generated PLS. The randomization process uses a computer-generated sequence with concealed allocation to ensure unbiased group assignment. The AI system used in this study is deployed locally on a secured UCLA intranet. It leverages a large language model (LLM) that has been customized and validated for generating plain language explanations of complex ophthalmologic information. All processing occurs on UCLA-approved, encrypted devices, and no data are transmitted externally. Before the PLS is provided to participants, each summary is reviewed by an ophthalmologist to verify accuracy and ensure that essential clinical details are correctly and clearly communicated. Data collection is performed using survey instruments. The survey includes a series of 5-point Likert scale items, open-ended questions, and structured response sections designed to assess comprehension of diagnosis, treatment plans, and follow-up instructions. Participants complete the survey immediately after their clinic visit, and a follow-up telephone interview is conducted approximately seven days later by trained research staff to capture additional feedback on clarity and retention of the information provided. The study does not employ audio or video recording; all responses are either directly recorded by research personnel or entered electronically into a secured database. Statistical analyses will be conducted using standard software packages to compare outcomes between the intervention and control groups. Primary analyses include independent t-tests or Mann-Whitney U tests for continuous variables, chi-square tests for categorical variables, and multivariable regression models to adjust for confounding variables such as age, education level, and baseline health literacy. The sample size was calculated to detect clinically meaningful differences in comprehension scores, with power analyses indicating a need for between 460 and 2030 participants depending on the effect size. Data security is maintained through rigorous measures. Electronic data are stored on encrypted, UCLA-secured laptops and in a secure Box repository. All data handling follows UCLA policies and IRB guidelines for data retention and destruction, with identifiable information destroyed using secure methods once it is no longer required. Quality control procedures include periodic audits of data entry, regular review meetings with study personnel, and cross-checks of survey responses against clinical records where applicable. An independent monitoring process is in place to ensure compliance with the study protocol and to address any deviations promptly. Overall, this study is designed to provide robust evidence on the feasibility and effectiveness of AI-generated PLSs in enhancing patient understanding of complex medical information. By integrating technical safeguards, rigorous statistical methods, and a streamlined data collection process, the research aims to deliver insights that may lead to improved patient communication strategies and more effective health care delivery across multiple specialties.
RECRUITING
The National Eye Institute (NEI) is conducting a study to evaluate and provide standard treatment to participants with various diagnosed and undiagnosed ocular conditions. Objective: The primary objective of this protocol is to collect data and specimens generated through clinical care procedures. Through this primary objective, the secondary objectives (establish a resource of patients with ocular conditions to facilitate recruitment into new research protocols at the NEI, gain additional knowledge about the course of specific ocular diseases and characterize the natural history of such diseases (to generate hypotheses for future clinical research studies), and evaluate the effects of standard of care treatments) may be achieved.
RECRUITING
STUDY OBJECTIVE:To evaluate the impact of predicted residual astigmatism in mixed dry eye patients regularly using Systane COMPLETE before cataract surgery. Hypothesis:Regular use of Systane COMPLETE in mixed dry eye subjects before cataract surgery may lead to more accurate astigmatism predictions. Objectives:To evaluate the Impact of predicted residual astigmatism in mixed dry eye patients regularly using Systane COMPLETE before cataract surgery. Inclusion Criteria The subjects aged 20-85 years, with normal cognitive function and capable of answering related questionnaires who require phacoemulsification and intraocular lens implantation under topical anaesthesia, are the eligible candidates. Exclusion Criteria Unable to answer the questions in the dry eye survey. Ocular trauma or ocular surgery in the planned surgical eye, active ocular infection, and obvious abnormalities in ocular surface or eyelid margins other than MGD cause decreased visual acuity other than cataracts. Dry eye signs: Corneal Fluorescein Staining CFS (+) to exclude any corneal abnormalities or epithelial defect. Systemic drug use, including tetracycline derivatives, antihistamines, and isotretinoin. Using dry eye medication at screening stage. Research Process V1 Screening (1-2 month before surgery) The subjects' demographic information will be collected. The pre-op assessments will be performed, and Informed Consent will be explained and endorsed during this visit. Systane COMPLETE MD1 bottle will be prescribed to all subjects who signed the ICF, with a dosing frequency of 1-2 drops q.i.d OU for 1-2 month. The LENSTAR 900 device (Haag-Streit Swiss) will be used to measure the biometry of the anterior cornea's keratometry at each visit. The measurement will be taken through five consecutive scans with only a few seconds of interval between each scan. The mean keratometry of these five scans will be used. Anterior corneal surface maps from Pentacam (OCULUS, Germany) will be used to identify patients with keratoconus or corneal irregularities at each visits. V2 Pre-operative (7 days before surgery) All participants will receive refractive examinations and take dry eye assessments. Repeat the same biometry measurement as the first visit. The final choice of the IOL for surgery is based on biometry measurements and Barrett Toric calculation. One eye per subject will be analysed. V3 Surgery day The participants will receive phacoemulsification and intraocular lens implantation. The participants with any intra-operative complication will be excluded from the study. To ensure compliance with the medication, it is required that the subjects return the used Systane COMPLETE bottle and medication diary at V3.
RECRUITING
STUDY OBJECTIVE: Compare the corneal astigmatism data before and after the use of Systane COMPLETE to evaluate its impact on predicting changes in postoperative residual astigmatism. Compare the effects of using or not using Systane COMPLETE on preoperative and postoperative Ocular Surface Disease Index (OSDI) scores and Non-Invasive Tear Break-Up Time (NITBUT). Background Cataract surgery is one of the most common and successful ophthalmic surgeries worldwide. However, cataract surgery can induce or exacerbate the severity of dry eye, leading to increased postoperative discomfort for patients. Additionally, undiagnosed preoperative dry eye can affect the accuracy of corneal astigmatism measurements, potentially impacting the astigmatic correction power of toric intraocular lenses used during surgery. While general moisturizing artificial tears have been shown to significantly reduce postoperative ocular discomfort and tear film instability, it is notable that up to 50% of patients undergoing refractive or cataract surgery exhibit abnormalities in the tear film lipid layer, meeting the diagnostic criteria for meibomian gland dysfunction (MGD). Given this, the application of lipid-containing nano-emulsion artificial tears before and after cataract surgery presents an unexplored opportunity to address two critical issues: reducing errors in corneal astigmatism measurements and alleviating dry eye symptoms induced by cataract surgery. This remains a topic worthy of investigation, as no existing studies have thoroughly examined these aspects. Methods This study is an extension of the "Optimizing the Ocular Surface with Systane COMPLETE in Patients with Dry Eye Planning for Cataract Surgery" trial (Research Ethics Committee Approval Number: 202311109MIPD), hereinafter referred to as the OOSSCC trial. The original OOSSCC trial began recruitment in May 2024 and focuses on analyzing patients with dry eye symptoms scheduled for cataract surgery. The trial evaluates the changes in corneal anterior surface astigmatism measurements, Ocular Surface Disease Index (OSDI) scores, and Non-Invasive Tear Break-Up Time (NITBUT) before and after one month of preoperative treatment with Systane COMPLETE.This trial will extend the study period to one month post-surgery and will be divided into two parts: Experimental group: This part extends the use of Systane COMPLETE for participants in the original OOSSCC trial to one month post-surgery. The aim is to compare corneal data before and after using the trial drug to determine which time point provides more accurate predictions of postoperative residual astigmatism. The anticipated results may serve as a reference for preoperative management to reduce corneal astigmatism prediction errors in cataract surgery patients with an OSDI score greater than 12. Additionally, this study aims to assess differences in corneal astigmatism prediction accuracy among patients with varying NITBUT levels. control group: This part involves recruiting additional cataract patients who meet the same age and dry eye inclusion criteria as the original OOSSCC trial group to serve as a control group. It will compare the effects of using Systane COMPLETE on preoperative dry eye symptoms and postoperative dry eye symptoms. The anticipated results may provide recommendations for managing postoperative dry eye symptoms in cataract surgery patients with an OSDI score greater than 12. Anticipated Results It is expected that for cataract patients with preoperative dry eye symptoms, particularly those with meibomian gland dysfunction, the study will improve the effectiveness of postoperative astigmatism correction while reducing discomfort caused by dry eye symptoms after surgery. Hypothesis: Viscous artificial tears have been proven to alter preoperative corneal measurements in patients planning to undergo cataract surgery. This study aims to analyze the impact of lipid-containing nano-emulsion artificial tears on predicting residual astigmatism after cataract surgery. mpact on Meibomian Gland Dysfunction and Dry Eye Symptoms:Meibomian gland dysfunction is the most common cause of evaporative dry eye. Cataract surgery alters the structure and function of the meibomian glands and reduces the thickness of the tear film lipid layer. However, no studies have yet reported the effectiveness of this type of artificial tear in alleviating dry eye symptoms induced by cataract surgery. Objectives: Compare the corneal astigmatism data before and after the use of Systane COMPLETE to evaluate its impact on predicting changes in postoperative residual astigmatism. Compare the effects of using or not using Systane COMPLETE on preoperative and postoperative Ocular Surface Disease Index (OSDI) scores and Non-Invasive Tear Break-Up Time (NITBUT). Inclusion Criteria (experimental group) Cataract patients who participated in the "Optimizing the Ocular Surface with Systane COMPLETE in Patients with Dry Eye Planning for Cataract Surgery" trial (Research Ethics Committee Approval Number: 202311109MIPD) and did not withdraw from the trial midway. Exclusion Criteria (experimental group) Patients unwilling to participate in this trial after surgery. Inclusion Criteria (control group) Cataract patients aged between 20 and 85 years. Patients with normal cognitive function who are able to complete the dry eye questionnaire (with responses recorded by the research team) and are willing to undergo phacoemulsification and intraocular lens implantation under topical anesthesia. Exclusion Criteria (control group) Unable to answer the questions in the dry eye survey. Ocular trauma or ocular surgery in the planned surgical eye, active ocular infection, and obvious abnormalities in ocular surface or eyelid margins other than MGD cause decreased visual acuity other than cataracts. Dry eye signs: Corneal Fluorescein Staining CFS (+) to exclude any corneal abnormalities or epithelial defect. Systemic drug use, including tetracycline derivatives, antihistamines, and isotretinoin. Using dry eye medication at screening stage. Sample Size This study plans to enroll a total of 140 participants, with 70 participants in the trial group and 70 in the control group.
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