Corneal Melting Syndrome involves progressive thinning and degradation of the corneal tissue, which can lead to vision challenges. Clinical trials for this condition explore treatment evaluations aimed at slowing or halting corneal deterioration, alo...
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Found 29 Actively Recruiting clinical trials
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.
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.
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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.
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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.
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Phacoemulsification is a common cataract surgery performed under topical anesthesia, which is generally safe but can cause pain, anxiety, and discomfort for some patients. This research evaluates the effect of oral anti-anxiety medication, specifically Alprazolam, on improving patient satisfaction during second eye cataract surgery. The study aims to clarify whether oral sedation can reduce pain, anxiety, and side effects like nausea and dizziness compared to no sedation during phacoemulsification. Patients will receive either a single oral dose of Alprazolam or a placebo tablet 30 minutes before surgery. The dose of Alprazolam is 0.5 mg for most patients, with a reduced 0.25 mg dose for those over 65 years or with liver disease. The study compares these groups to assess how oral sedation affects anxiety, pain, and surgical satisfaction. This is an extension study involving patients undergoing surgery on their second eye with topical anesthesia. During the trial, participants will complete questionnaires assessing pain, anxiety, and overall satisfaction before and after surgery. Researchers will monitor intraoperative discomfort and postoperative anxiety levels. Data from approximately 250 patients will be collected and analyzed for these outcomes. This study runs from March 2025 to December 2027, focusing on improving cataract surgery experiences safely and conveniently.
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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.
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This research aims to compare different treatments for persistent epithelial defects (PED), which are corneal ulcers that do not heal within two weeks despite standard care. These ulcers result from missing substances in tears that normally help corneal healing, and the condition can worsen in diseases like diabetes. The study will evaluate whether autologous platelet-rich plasma (PRP) with a bandage contact lens heals PED faster than preservative-free lubricant with a bandage contact lens or eye patch with ocular lubricant ointment. Participants will be randomly assigned to one of three treatment groups: PRP eye drops with a bandage contact lens every 1 to 3 hours, preservative-free lubricant eye drops with a bandage contact lens every 1 to 3 hours, or an eye patch with ocular lubricant ointment applied every 24 hours. Treatments will continue until the corneal defect fully heals. If the ulcer worsens to corneal thinning or perforation, appropriate medical care will be provided. During the study, healing time will be closely monitored with assessments up to three months, including corneal sensitivity, visual acuity, ocular pain, surface symptoms, and quality of life. Researchers will also track adverse events, recurrences, and treatment failures. Weekly evaluations or sooner if needed will help measure progress, ensuring participant safety and thorough monitoring throughout the treatment period.
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Researchers are studying the relationship between clinical factors and the occurrence of adverse drug reactions in hospitalized patients who receive tropicamide/phenylephrine 8 mg/50 mg/mL. This study aims to identify which clinical determinants may increase the risk of these reactions and provide safety information for this commonly used ophthalmic drug combination. It also seeks to establish safety measures for patients undergoing eye examinations or surgery where these drugs are used. The study involves hospitalized patients scheduled for surgery who will receive two drops of tropicamide/phenylephrine 8 mg/50 mg/mL. Vital signs will be measured before administration and then at several time points afterward, including 5, 15, 30 minutes, and 1, 2, and 3 hours post-administration. Data will be collected using questionnaires and analyzed to find associations between clinical factors and adverse reactions. Participants will be monitored closely through vital sign checks and questionnaires during the study period. Researchers will evaluate adverse drug reactions and clinical determinants to understand their connection. The main outcome is to assess vital signs at set intervals following drug administration and identify any adverse reactions. The study is observational and aims to enhance the safety profile of this medication in hospitalized patients.
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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.
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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.
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