Corneal Endothelial Dysfunction

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 effectiveness of Lacripep 4 M Ophthalmic Solution in people with Stage 1 neurotrophic keratitis (NK), a condition affecting the cornea. This Phase 2 study compares Lacripep to a vehicle ophthalmic solution to see how each affects the eye surface, vision, corneal sensitivity, and quality of life. The trial involves about 54 participants and includes detailed eye image assessments by a central reading center to ensure objective results. Participants will first undergo a 2-week run-in period using the vehicle ophthalmic solution openly. Then, at the baseline visit, they are randomly assigned to receive either Lacripep 4 M or the vehicle solution. Both treatments are applied three times daily to both eyes for 8 weeks, with clinic visits at weeks 2, 4, and 8. After this, all participants enter a 4-week open-label phase where everyone receives Lacripep, allowing comparison of shorter and longer treatment durations. During the study, participants will have regular clinic visits for eye exams and assessments to monitor safety and effects on vision and corneal health. Researchers will measure the primary efficacy from baseline to week 8 and continue safety monitoring through week 12. The study includes checks on visual acuity, corneal sensitivity, and intraocular pressure, along with quality-of-life evaluations. Overall participation lasts about 12 weeks, including both masked and open-label treatment phases.

Researchers are evaluating the safety and effectiveness of STSP-0902 ophthalmic solution in adults with neurotrophic keratitis (NK), a condition affecting the cornea. This Phase II, double-blind, placebo-controlled study will enroll 48 patients diagnosed with Mackie Stage 2 or 3 NK in one or both eyes. The goal is to better understand how this eye drop treatment impacts corneal healing and eye health compared to placebo. Participants will be randomly assigned to one of three dosing groups: low dose given three times daily, low dose given six times daily, or high dose given three times daily. Each group will include both patients receiving the active drug and those receiving a placebo. Treatments will be applied topically to the affected eye(s) for 8 weeks. If the eye is not healed after this period, patients may receive standard care during follow-up. During the study, participants will undergo various eye exams including slit-lamp exams, optical coherence tomography, and intraocular pressure measurements from screening through week 10. Researchers will monitor symptoms, vital signs, lab tests, and heart activity. Corneal healing, sensitivity, vision quality, tear secretion, and presence of antibodies against the drug will also be assessed. The total participation time includes the 8-week treatment and follow-up periods ending around week 10.

Researchers are evaluating KB801, a special virus-based treatment designed to deliver human nerve growth factor to the corneas of people with Stage 2 or 3 neurotrophic keratitis, a condition that affects corneal healing. This Phase 1/2 study is designed to assess the safety, tolerability, and early signs of effectiveness of KB801 compared to a placebo. The study is double-masked and placebo-controlled, involving participants with persistent corneal epithelial defects that have not improved. Participants will be randomly assigned to receive either KB801 or a placebo, applied topically to the affected eye once daily for 8 weeks. After completing treatment, they will return for a follow-up visit two weeks later to check on safety and the stability of corneal healing. Further safety monitoring will take place every three months for about one year while participants remain in the study. Throughout the trial, participants will undergo regular assessments to monitor safety, including tracking any adverse events. Researchers will evaluate healing of the corneal defects using specific measurements over 8 to 10 weeks. Safety follow-up visits extend through approximately one year to observe the durability of treatment effects and overall tolerability. Participants can expect regular visits for examinations and safety monitoring during this time.

Researchers are evaluating the safety and effectiveness of NEXAGON4 (lufepirsen ophthalmic gel) in people with persistent corneal epithelial defects (PCED), a condition where the corneal surface does not heal properly. This randomized, double-masked, vehicle-controlled study aims to understand how well NEXAGON works in treating PCED and its durability after treatment. This Phase 2 trial is sponsored by Glaukos Corporation and is conducted at multiple centers. Participants will be randomly assigned to receive one of three treatments applied topically to the eye once a week for 4 to 8 weeks: a high dose of lufepirsen, a low dose of lufepirsen (available only at EU sites), or a vehicle gel without the active drug. After the treatment period, a 4-week follow-up will monitor the condition. If the corneal defect does not heal or the healing is not maintained for 28 days, participants may enter an open-label treatment phase with NEXAGON for an additional 8 weeks. During the study, participants will undergo screening to confirm eligibility, receive weekly treatment applications, and be monitored for safety and healing progress. Researchers will assess corneal re-epithelialization and its durability as the main outcome. The total study participation includes the screening, up to 8 weeks of treatment, 4 weeks of follow-up, and possibly an 8-week open-label extension. Safety, efficacy, and healing durability will be closely observed throughout these periods.

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.

Researchers are evaluating the safety and effectiveness of cenegermin ophthalmic solution compared with a vehicle solution in treating Persistent Corneal Epithelial Defect (PCED). This phase 3, randomized, double-masked, vehicle-controlled study aims to determine whether cenegermin can induce complete healing of the corneal epithelium after 4 weeks of treatment. The trial is sponsored by Dompé Farmaceutici S.p.A and involves multiple centers. Participants will be randomly assigned to receive either the active drug cenegermin or a vehicle solution applied topically to the affected eye. The study includes three main periods: an 8-week initial treatment phase, followed by an 8-week extension treatment phase, and then a 24-week follow-up phase to monitor ongoing effects and safety. Throughout the study, participants will undergo assessments to measure the healing of the corneal epithelium, including the proportion achieving complete healing at weeks 4 and 8. Researchers will also track changes in the size of the epithelial defect and record any adverse events or reasons for discontinuation. The total study duration for each participant is 40 weeks, with regular evaluations during treatment and follow-up periods.