Acanthamoeba keratitis is an uncommon but serious eye infection that primarily affects the cornea. Clinical trials investigating this condition broadly examine treatment evaluations and monitoring approaches to better manage the infection and its per...

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Found 31 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are evaluating the first use of a new imaging technology called 4D Microscope Integrated Optical Coherence Tomography (4D MIOCT) combined with a Zeiss Artevo 800 surgical microscope during eye surgeries. This study focuses on adult patients undergoing clinically indicated surgery for various eye diseases, aiming to assess how easy the system is to use, its safety, and how well it visualizes the eye's structures during both front and back segment procedures. The study involves using the investigational 4D MIOCT device integrated into the Zeiss Artevo 800 microscope to capture detailed images of the eye during surgery. This imaging is performed in the operating room as part of the standard surgical care, with no additional treatment or interventions added. Up to eight patients may be enrolled, and images will be taken of one or both eyes during surgery to observe normal and abnormal microanatomy, as well as track any injections under the retina. Participants will have their eye imaged during surgery, and researchers will collect related clinical data and previous eye care records for comparison. The images and data will be analyzed after surgery to explore new details captured by the 4D MIOCT system. Researchers will measure ease of use, surgical workflow impact, and the presence of normal and abnormal microanatomy based on the images. There is no extra risk beyond the usual surgery, and no new medications or procedures will be performed solely for research purposes.

Age: 18Years +All GendersPhase Not Applicable
1 location
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Actively Recruiting

Researchers are evaluating the safety and clinical activity of different doses of belantamab mafodotin combined with lenalidomide, dexamethasone, and nirogacestat in patients with newly diagnosed multiple myeloma who are not able to undergo a transplant. This phase 1/2, open-label study aims to find the recommended dose for future studies and to explore how to manage eye-related side effects. About 36 participants will be enrolled, with follow-up lasting up to 3 to 4 years after enrollment ends. Belantamab mafodotin is given intravenously every other 28-day cycle at doses ranging from 1.0 to 1.9 mg/kg. Lenalidomide is taken orally daily on days 1 to 21 of each 28-day cycle. Dexamethasone is given either orally or intravenously on days 1, 8, 15, and 22 of each cycle, with dose adjustments based on age. Nirogacestat is taken twice daily starting three days before the first dose and on the same days as belantamab mafodotin. The study has two parts: dose finding to establish the best dose, followed by dose expansion with random assignment to different dose modification guidelines for eye side effects. Participants will undergo regular assessments to monitor side effects, including eye exams, and overall response to treatment. Researchers will track dose-limiting toxicities, adverse events, ocular toxicity, and response rates over up to four years. Additional evaluations include measuring drug levels, disease progress, and survival. Participants must provide consent and will be closely monitored throughout the study period, which is expected to last approximately four years in total.

Age: 18Years +All GendersPhase 1Phase 2
2 locations
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Actively Recruiting

Researchers are studying the accuracy of measuring total corneal astigmatism compared to the actual corneal astigmatism under different regional measurement settings. This observational study focuses on patients who have undergone phacoemulsification surgery, with or without the implantation of toric intraocular lenses (IOLs), and have a certain degree of corneal astigmatism. The goal is to find the best region setting for measuring corneal astigmatism accurately. Participants with corneal astigmatism will have various eye measurements taken using specialized devices. These include total corneal astigmatism and anterior chamber depth measured by a Scheimpflug tomographer, pupil size assessed by the itrace and MONCV3 devices, and residual astigmatism evaluated through subjective refraction. The study observes these measurements at least one month after their cataract surgery. During the study, participants will undergo eye exams and tests to collect the necessary data. Researchers will analyze differences in vectorial measurements, pupil sizes, residual astigmatism, and anterior chamber depth to determine measurement accuracy. The study monitors these outcomes to optimize corneal astigmatism measurement methods. Participation duration varies depending on individual schedules and follow-up visits.

Age: 18Years +All Genders
1 location
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Actively Recruiting

Healthy Volunteer

Researchers are investigating the immediate effects of cigarette smoking on the cornea's structure and measurements in healthy adults aged 18 to 60 years. This prospective, controlled study compares smokers and non-smokers to see if short-term smoking causes measurable changes in corneal tomography and biometric parameters. The study includes 46 smokers and 46 non-smokers to better understand how acute smoking exposure might affect eye health. Participants are divided into two groups: active smokers and non-smokers. Both groups undergo initial full eye examinations and measurements using a Pentacam device focused on the right eye to avoid data overlap. After baseline measurements, participants spend 10 minutes outdoors under standard conditions; smokers smoke during this period while non-smokers do not. The same eye measurements are taken immediately after this exposure period to compare changes within and between the groups. Throughout the study, participants undergo detailed eye exams and Pentacam imaging to measure corneal thickness and densitometry at the pupil center before and after the smoking or non-smoking exposure. Researchers monitor changes in these parameters to assess the acute impact of smoking on eye structures. The study duration includes baseline assessment, the 10-minute exposure period, and immediate post-exposure measurements to capture short-term effects.

Age: 18Years - 60YearsAll Genders
1 location
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Actively Recruiting

Healthy Volunteer

Researchers are developing and managing the AnovaOS Network Powered Patient Registry to collect real-world patient data across various diseases globally. This registry aims to capture meaningful clinical information on diagnosis, infection course, treatments, and outcomes to enhance understanding and support future clinical trials and observational studies. The registry serves as a resource to better understand, prevent, diagnose, and treat diverse health conditions. Participants' data will be gathered through this registry, which can also be used to recruit individuals for clinical trials and observational studies on promising therapies. The registry collects ongoing information on patients' health status and treatments, enabling long-term monitoring and analysis. This observational study does not involve administering treatments but focuses on data collection and management. Participants will provide information through questionnaires or instruments, either personally or via an informed proxy, with an expected follow-up once per year. The research team will assess natural history, clinical effectiveness, safety, and quality of care over a period of five years. The registry includes patients with a wide range of conditions, and participation requires informed consent and the ability to complete follow-up data collection.

Age: 18Years +All Genders
1 location
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Actively Recruiting

Researchers are evaluating a deep learning algorithm designed to identify multiple corneal diseases using anterior segment images. The study aims to validate this algorithm by measuring its accuracy through sensitivity, specificity, positive predictive value, negative predictive value, and area under the curve. The study is observational and focuses on improving screening methods for corneal diseases. The intervention involves applying the artificial intelligence algorithm to diagnose corneal diseases from slit-lamp images. The algorithm analyzes key regions in the images, including the sclera, pupil, and lens, to detect disease presence. There are no treatment groups since this is a diagnostic study. Participants provide slit-lamp images that must meet quality standards, ensuring over 90% of the image area is clear for reading and discrimination. Researchers assess the algorithm's performance by comparing its diagnoses with clinical standards within one week. Outcome measures include the area under the curve, sensitivity, and specificity. The study is conducted under the oversight of Tianjin Eye Hospital and does not involve healthy volunteers.

All Genders
1 location
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Actively Recruiting

Healthy Volunteer

This research aims to develop and test a practical model for remote eye care consultation using vision self-testing. It focuses on overcoming barriers faced by patients, clinicians, and the healthcare system when adopting remote consultations, especially issues related to technology trust and visual acuity assessments. The study is observational and involves collaboration between patients, the public, and NHS staff to create a sustainable and inclusive solution. The study uses an innovative approach with the DigiVis app for vision self-testing during remote consultations. It takes place in three diverse NHS eye departments and involves co-designing the implementation model with stakeholders. Patients are assigned to the remote consultation pathway by their clinicians. The model will be evaluated before, during, and after 14 months of operation, including questionnaires completed online by both patients and staff to assess their experiences and attitudes. Participants will complete online questionnaires before and after their remote consultation to measure their views on the e-health technology, while staff will complete surveys to assess how well the technology is integrated into routine practice. The main outcomes include changes in patient perceptions and staff normalization of the technology over 30 months. The study will also collect qualitative data from interviews and focus groups to understand challenges and support model improvements. The overall participation duration can last up to 30 months including follow-up assessments.

Age: 4Years +All Genders
2 locations
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Actively Recruiting

Researchers are studying complex ocular infections, including endophthalmitis and corneal abscesses, to improve the methods used for microbiological diagnosis. These infections are challenging to diagnose because of small sample volumes and difficult access to the eye. New molecular tools like metagenomic sequencing and multiplex polymerase chain reaction (PCR) are being evaluated to optimize diagnosis accuracy and speed. The study involves patients with complex ocular infections. For endophthalmitis, next-generation sequencing (NGS) and culture methods will be used to analyze ocular samples. For corneal abscesses, multiplex PCR will be added to the diagnostic process to potentially shorten the time to diagnosis. These molecular techniques are being assessed alongside standard methods to understand their impact on diagnosis. Participants will provide ocular samples which will be tested with the new molecular techniques and traditional culture methods. Researchers will measure the positivity rates of samples within two weeks, and evaluate microbiological diagnosis accuracy, time to diagnosis, visual acuity, cure rates, and any changes in anti-infectious treatment during an 18-month follow-up. The study is observational and aims to improve diagnosis for better management of these infections.

Age: 18Years +All Genders
1 location
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Actively Recruiting

Healthy Volunteer

Researchers are collecting Optical Coherence Tomography (OCT) data to study both normal and diseased eyes, including conditions such as retinal disease, glaucoma, and corneal disease. This observational study aims to gather detailed imaging information to better understand these eye conditions using the A10900 OCT device. Participants will undergo OCT imaging with the A10900 device, which captures detailed pictures of the eye's structures. The study includes groups with retinal disease, glaucoma, corneal disease, and healthy eyes. Each participant will have OCT scans taken to collect data relevant to their specific eye condition or normal eye status. During the study, participants will have their eyes scanned with OCT and may undergo vision tests like best-corrected visual acuity (BCVA). Researchers will count the number of OCT scans performed over one year to measure outcomes. Participants will be monitored for their ability to tolerate imaging and comply with study procedures. The study includes healthy volunteers and people with various eye diseases, with ongoing safety and imaging quality assessments.

Age: 22Years +All Genders
4 locations
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Actively Recruiting

This research aims to follow patients with corneal diseases, particularly corneal ectasia such as keratoconus, to analyze the quality of surgical treatments and diagnosis over the long term. Keratoconus causes the cornea to become steeper, thinner, and irregular, leading to irreversible vision loss. Surgical interventions like corneal cross-linking are performed if the disease progresses, making long-term monitoring essential to detect early disease changes and confirm treatment stability. Participants may undergo diagnostic tests including corneal topography and tomography for detailed assessment. The study focuses on observing the natural course and treatment outcomes over 15 years, including postoperative follow-ups. Various eye examinations and measurements are performed, such as anterior optical coherence tomography, Scheimpflug-based tomography, biomechanical assessments, optical biometry, confocal microscopy, and endothelium cell counts. During the study, participants will have regular evaluations of their corneal condition and treatment effects. Researchers collect data on factors like age, sex, family history, previous surgeries, and medications. The main outcomes measured are follow-up intervals and postoperative follow-up intervals over 15 years, as well as assessment of treatment quality. Participants can expect ongoing monitoring to understand disease progression and treatment success throughout the study period.

Age: 18Years - 65YearsAll Genders
1 location

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