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Keratitis clinical trials

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NCT ID: NCT06364878 Recruiting - Clinical trials for Infectious Keratitis

Non-invasive Diagnostics of Microbial Keratitis

Start date: August 23, 2023
Phase:
Study type: Observational [Patient Registry]

Infectious keratitis is a significant cause of partial vision loss and blindness and places a large burden on eye care professionals. One of the main challenges for the ophthalmologist when presented with a case of suspected microbial keratitis is the determination of the subtype of keratitis. It must be determined whether the origin of the infection is bacterial, viral, fungal, or parasitic, in order to prescribe a correct, effective treatment aimed at the causative pathogen. In daily practice this can be challenging, and general treatments with antibiotics are prescribed. Some cases then experiences deterioration, resulting in more patients visits and further rounds of invasive treatments and progressive vision deterioration. This project is designed to break this cycle of nonspecific diagnosis, suboptimal treatment, and progressive worsening of vision with increased interventions. New, advanced diagnostics will be brought into the clinic to provide additional information which, if our hypothesis is correct, will result in more rapid and accurate diagnosis of the keratitis subtype. This will translate into earlier administration of a more targeted treatment, avoiding the repeated round of non-targeted treatment and progressive worsening of the patient's vision. This can directly reduce to number of clinic visits and specialist time required for treatment and follow-up of keratitis, knowledge of how the eye responds to various microbes by initiating a specific cascade of molecular inflammatory signals and changes in protein expression in the tear film. Using in vivo confocal microscopy (IVCM) we will document the cellular status of the cornea and identify microbes infecting the cornea in real-time. Secondly, tear samples will be obtained from patients with keratitis to evaluate and quantify the molecular cytokine signatures associated with specific microbial species, confirmed by microbiological culture. We will for the first time develop cytokine profiles for the various types of infection, identifying diagnostic cytokines which in the longer term can lead to development of rapid point-of-care biomarker diagnostics. The project aims are translated into the following hypotheses: H1: In vivo confocal microscopy imaging features detect microbial keratitis consistent with clinical assessment and outcome at a greater frequency than microbiological culture results. H2: Cytokine profiles (or a subset of molecules) in the eye are specific for viral, bacterial, fungal, or amoebic keratitis; and H3: A combination of in vivo confocal microscopy and molecular profiling of the tear film can yield a specific keratitis diagnosis closely matching the clinical progression and outcome of keratitis.

NCT ID: NCT06229379 Recruiting - Cataract Clinical Trials

The Effects of a Large Language Model on Clinical Questioning Skills

Start date: September 1, 2023
Phase: N/A
Study type: Interventional

The researchers have used the ophthalmology textbook, clinical guideline consensus, the Internet conversation data and knowledge base of Zhongshan Ophthalmology Center in the early stage, combined with artificial feedback reinforcement learning and other techniques to fine-tune and train the LLM, and developed "Digital Twin Patient", a localized large language model that has the ability to answer ophthalmology-related medical questions, and also constructed a combination of automated model evaluation and manual evaluation by medical experts. The evaluation system combining automated model evaluation and manual evaluation by medical experts was constructed at the same time. This project intends to integrate "Digital Twin Patient" into undergraduate ophthalmology apprenticeship, simulate the consultation process of real patients through the online interaction between students and "Digital Twin Patient", explore the effect of "Digital Twin Patient" consultation teaching, provide emerging technology tools for guiding medical students to actively learn a variety of ophthalmology cases, cultivate clinical thinking, and provide the possibility of creating a new mode of intelligent teaching.

NCT ID: NCT05888987 Recruiting - Clinical trials for Infectious Keratitis

Use of a New Method for the Microbiological Diagnosis of Severe Corneal Infection

ABCORFILM
Start date: July 7, 2023
Phase:
Study type: Observational

Microbial keratitis is a severe and often blindness-inducing pathology which represents today the first reason for long-term hospitalization (more than 5 days) in ophthalmology. Its diagnosis is clinical and leads to an immediate hospitalization in the presence of serious criteria (Mackie classification). The entire process of microbiological diagnosis requires several days before etiological confirmation and therefore delays the initiation of targeted therapy. Recently, new PCR systems allowing the detection of 18 to 27 pathogens in 75 minutes have been developed. Their use could thus be transposed to ophthalmology by adapting the microbiological diagnostic technique to samples currently taken by swabbing the cornea. The investigators will compare their diagnosis performance versus conventional methods on patients who suffered for a microbial keratitis with severity criteria.

NCT ID: NCT05888883 Recruiting - Microbial Keratitis Clinical Trials

Microbial Keratitis Sampling for Biomarker Discovery

Start date: August 1, 2023
Phase:
Study type: Observational

The goal of this observational study is to identify prognostic and/or diagnostic signatures (biomarkers) related to microbial keratitis outcomes. We will compare tear and ocular swab samples from participants currently suffering from microbial keratitis to healthy control participants. The primary study objective is to undertake analysis (proteomics and metabolomics) of microbial keratitis patient (and healthy control) ocular samples collected throughout the patient treatment course to better understand the ocular microenvironment and to identify candidate biomarkers for future targeted screening and validation studies. The secondary study objective is to define the microorganisms in patients with microbial keratitis through a better understanding of the ocular surface micro/mycobiome (the resident bacteria and fungi) in health and disease Participants will have their tears collected via capillary tube during their treatment course, and swabs of their conjunctiva collected at their first and final appointments.

NCT ID: NCT05720715 Recruiting - Clinical trials for Outcomes of Cyclosporine Eye Drops in Herpetic Keratitis

Clinical Outcomes of Cyclosporine Eye Drops in Management of Herpetic Keratitis

Start date: January 1, 2022
Phase: Phase 4
Study type: Interventional

Objective: To compare the additive effect of topical cyclosporine A 0.05% eye drops to prednisolone eye drops, with topical prednisolone acetate 1% eye drops alone in treatment of herpetic stromal keratitis. Methods: Patients diagnosed with herpetic stromal keratitis are randomly divided into 2 groups; Group A: receive cyclosporine eye drops together with prednisolone eye drops. Group B: receive topical prednisolone with placebo eye drops (tear replacement). The 2 groups receive systemic acyclovir therapeutic dose 400 mg five times daily, which then tapered to twice daily prophylactic dose after one month of treatment. Follow up for patients is scheduled as a weekly visit for a duration of 2 months.

NCT ID: NCT05620264 Recruiting - Keratitis Bacterial Clinical Trials

Validation of Interleukins and Other Cytokines Together With OCT Imaging for Rapid Infectious Keratitis Assessment

VICTORIA
Start date: March 21, 2022
Phase:
Study type: Observational [Patient Registry]

As conventional corneal scraping with bacterial culturing has several disadvantages such as long duration until diagnosis, invasiveness and lacks alternatives, there is demand for a novel non-invasive, rapid test in keratitis management. First aim of this study will be to evaluate the influence of TNF-alpha on Gram+ and Gram- bacteria causing keratitis. Second aim of this study will be to develop an algorithm, that should help to distinguish between different pathogens causing keratitis.

NCT ID: NCT05566717 Recruiting - Clinical trials for Diabetic Retinopathy

An Investigator-Initiated Study to Assess the Association of Diabetic Retinopathy Severity Scale (DRSS) With Level of Decreased Corneal Sensitivity

Assess
Start date: July 1, 2022
Phase:
Study type: Observational

Evaluate the association between level of decreased corneal sensitivity and diabetic retinopathy severity scale

NCT ID: NCT05552261 Recruiting - Clinical trials for Neurotrophic Keratitis

DEFENDO Long Term Follow-up Study in Stage 1 NK Patients

DEFENDO
Start date: December 20, 2022
Phase:
Study type: Observational

The primary objectives are to evaluate the long-term safety and efficacy of OXERVATEâ„¢ 0.002% (20 mcg/mL) cenegermin-bkbj ophthalmic solution in Stage 1 Neurotrophic Keratitis (NK) patients who enrolled in the DEFENDO Study.

NCT ID: NCT05432336 Recruiting - Keratitis Clinical Trials

Complex Ocular Infection, Optimization of Microbiological Diagnosis

ICODIA
Start date: November 21, 2023
Phase:
Study type: Observational

The purpose of this study is to evaluate the impact of different technique to optimize the microbiological diagnosis of the COI. - Metagenomic for the endophtalmitis - Multiplex polymerase chain reaction for corneal abscesses

NCT ID: NCT05268718 Recruiting - Clinical trials for Keratitis, Ulcerative

Au-Ag-Cu2O NG With PTT Anti Drug-resistant Microbial Keratitis

Start date: August 1, 2021
Phase: Early Phase 1
Study type: Interventional

This clinical study was conducted to evaluate the efficacy and safety of gold-silver cuprous oxide composite nanogels combined with photothermal therapy system in the treatment of severe drug-resistant bacterial keratitis ineffective by traditional antibiotic treatment in human eyes, and to provide translational applications. Based on the clinical evidence, a more effective and safe innovative treatment plan for corneal diseases has been developed.