Keratoconus

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.

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.

Researchers are evaluating the potential of a new technique called Brillouin microscopy to diagnose corneal conditions such as keratoconus and ectasia. The study compares the biomechanical properties of corneas in people with keratoconus, those with post-LASIK ectasia, and individuals with normal corneas. This observational study aims to better understand differences in corneal tissue using this advanced imaging method. Participants include volunteers with normal corneas, patients diagnosed with various stages of keratoconus, individuals who had LASIK surgery with or without complications, people scheduled for PRK or LASIK surgery, and patients with Fuch's endothelial corneal dystrophy. The study involves axial scans of the cornea using Brillouin imaging to assess and compare corneal biomechanics across these groups. Specific inclusion and exclusion criteria apply to each group based on diagnosis, prior surgeries, and other eye health factors. During the study, participants undergo corneal imaging to measure the cornea's elastic modulus, reflecting its biomechanical properties. Researchers monitor these properties over time to evaluate the diagnostic capabilities of Brillouin microscopy. Participants will be assessed for corneal health through topography, pachymetry, and clinical evaluations, with the study lasting several years to gather comprehensive data. The research team also excludes individuals unable to understand imaging instructions or with certain eye conditions to ensure accurate measurements.

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.

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.

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.

This research aims to analyze the factors influencing high-order aberrations following Small Incision Lenticule Extraction (SMILE) surgery, focusing on patients with lenticule retained. High-order aberrations are key indicators used to assess visual quality after refractive surgery. While previous studies have explored complications related to these aberrations, there is limited high-quality research on patients with covert residual lenticule, which complicates clinical decisions about additional surgery. The study compares high-order aberrations between patients with and without peripheral residual lenticule to provide a detailed evaluation of postoperative visual quality. It involves two groups: the lenticule retained group and the non-lenticule retained group. This observational study does not involve treatment interventions but collects data to understand the relationship between residual lenticule and visual outcomes. Participants will be followed up with assessments of higher-order aberrations at 90 days post-surgery. The study includes clinical evaluations and wavefront analysis to measure visual quality objectively. The findings aim to guide improvements in SMILE surgical techniques and postoperative care. The total participation involves initial assessment and follow-up visits as per the study plan.

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.

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.

Researchers are evaluating a multifunctional ophthalmic measuring device designed for eye examinations. This clinical investigation aims to refine the device's design by adjusting light source intensity, camera settings, and acquisition time to cover a wide range of patients. The study will also assess the safety and clinical performance of the device for measuring parameters related to conditions such as accommodation disorder, keratoconus, dry eye, and refractive errors. The investigation involves a single visit for each of the 378 participants, who will undergo measurements using the investigational device. The device will capture images and parameters of the anterior and posterior chambers of the eye, including axial biometry and physiological features of the anterior chamber. These measurements are collected during the visit to evaluate the device's ability to successfully acquire the intended data. Participants will be assessed during one visit at the study center, where various eye measurements will be taken using the device. Researchers will monitor the frequency of successful measurements to determine the device's clinical performance. Participants must be able to sit upright in front of the device for the evaluation. Safety and effectiveness will be recorded, and the study is expected to end in August 2025.