36 Clinical Trials for Various Conditions
A prospective, open-label, single-site clinical trial designed to evaluate the repeatability and reproducibility of biomechanical imaging by the BOSS device. Subjects will undergo unilateral biomechanical mapping of the cornea and lens by three BOSS devices operated by three (3) different operators.
This study will assess the value of improved magnetic resonance imaging (MRI) techniques to study the lens of the human eye. Knowledge of how cataracts develop and progress has been hampered by the lack of human tissue available for study; MRI may provide an effective means for learning more about this eye disease. Normal volunteers between 18 and 70 years of age may be eligible for this study. Participants will undergo a medical history and complete eye examination, including vision assessment, eye pressure measurement, lens and retina examinations, and photography of the eye. MRI scans will be scheduled for a second visit. For this procedure, the volunteer's pupils are dilated and he or she then lies on a stretcher that is moved into a cylinder containing a magnetic field. A device similar to a welder's helmet is placed on the head. Attached to the device are an imaging probe and a small blinking light. The probe receives radio signals from the eye that a computer converts into images. During imaging, the participant gazes at the blinking light; this helps keep the eyes from blinking and wandering. Scan times vary from 2 to 10 minutes; the total time for the study is less than an hour.
Study of safety and efficacy of UNR844 in subjects with presbyopia.
Assessing DEXTENZA efficacy when placed within the upper eyelid canaliculus as opposed to the lower eyelid canaliculus.
The purpose of this research is to determine if a new investigational contact lens shape allows the eye to get more oxygen.
This study compares contact lens comfortable wear duration, and signs and symptoms of contact lens discomfort, test versus control.
Discomfort with contact lens wear is the biggest reason why people stop wearing contact lenses. The investigators believe that inflammation is one of the causes of discomfort, and by blocking the inflammation using lifitegrast, the investigators may be able to relieve some of that discomfort. This study will enroll 50 subjects with contact lens discomfort and will receive lifitegrast to use over a period of approximately 3 months.
Specific Aims 1. Develop risk assessment scores for SCL wearers 2. Test the scoring algorithm in SCL wearers who present with adverse events 3. Explore targeted patient education to reduce risk behaviors associated with SCL wear.
This study will evaluate a system developed to grade the severity of age-related cataract, a common cause of vision loss in older adults. Cataract research requires methods to simply and accurately determine the type and severity of cataracts in order to develop new, possibly non-surgical, treatments. Patients 50 years of age and older with one of the three major age-related cataract types (nuclear, cortical, and posterior subcapsular) may be eligible for this study. Participants will be recruited from among patients enrolled in other National Eye Institute protocols. Participants will have their eyes examined independently by two ophthalmologists with a biomicroscope, a magnifying device routinely used during eye examinations. The doctors will use the new grading system to record if a cataract is present, and if so, how severe it is. The examination includes measurement of visual acuity (vision chart test) and examination of the lens, retina, pupils and eye movements. Photographs of the eye will be taken using a special camera that flashes a bright light in the eye.
A clinical trial using Senofilcon A daily lenses in the treatment of moderate to severe dry eye. This a comparison between signs and symptoms prior to and during treatment.
The investigators plan to conduct an R61/33 hybrid type 2 implementation-effectiveness trial that includes 1) a one-year exploratory R61 phase that will enable the development of the intervention protocol needed for the R33 trial phase including concrete R61 phase milestones; 2) a four-year R33 phase that will include a concurrent implementation evaluation and a randomized control trial.
The goal of this clinical trial is to learn if a new contact lens device can record patterns in eye pressure for 24 hours in adults with glaucoma and in healthy participants. The main questions it aims to answer are: * Is the contact lens device able to detect patterns in eye pressure that happens naturally between nighttime and daytime? * Are the contact lens recording patterns similar when repeated one week later? * What eye problems do participants have when wearing contact lens for up to 24 hours? Researchers will compare if the recordings detected by the contact lens over 24 hours are similar to the patterns measured by an eye pressure measuring instrument used in a doctor's office. Participants will * Wear contact lens in one eye for up to 24 hours * Take recordings in that eye with smartphone camera every 15 minutes when awake * For those participants who are able to stay overnight at a hotel for the trial, researchers will measure the eye pressure in the other eye every 1 to 2 hours when awake with an eye pressure measuring instrument.
Miebo (Perfluorohexyloctane) is a novel, non-aqueous, single entity, preservative free, ophthalmic drop. This drop was recently approved by the Food and Drug Administration (FDA) for the treatment of Meibomian Gland Disease (MGD). All published data on Miebo has been done in non-contact lens wearers. As contact lens dropout rates seem to be an ongoing problem for practitioners, we are performing this study utilizing this novel new drug with contact lens patients to determine if the drops assist comfort in typical soft contact lens wearing patients. If the study determines that Miebo assists in the overall comfort of contact lens patients this could be a possible way to help keep patients in their contact lenses longer.
Soft multifocal contact lenses are used for a variety of reasons in patient care. Multifocal contact lenses are most often used to correct presbyopic vision by providing a range of clear vision at both distance and near. Multifocal contact lenses correct vision at different distances by introducing a power gradient over the eye. They are designed using center near or center distance designs. For center near designs, the near addition is place in the center of the lens, and the power becomes more negative in the periphery. Conversely, for center distance designs, the distance prescription is placed in the center, and the power of the lens becomes more positive in the periphery in order to provide the near addition. Center near and distance designs have varying advantages and disadvantages for presbyopic vision correction, so a fitter may choose a specific design based on a patient's individual visual needs. Generally, it is thought that center near designs provide the most accommodative relief and superior near vision because the near addition is centered in the pupil and able to allow maximum near correction, even with miotic pupil size changes associated with accommodation. Plus lenses, or add powers, in spectacles are often used in the management of accommodative and binocular vision disorders. An add power, or plus lens, relieves accommodative demand. There is conflicting evidence on whether the add power in soft multifocal contact lenses can be used to manage accommodative and binocular vision disorders. Some case reports demonstrate benefits of multifocal contact lenses in accommodative insufficiency and convergence excess but the evidence is not clear and many previous studies utilize lenses that are not readily used anymore. Studies show that soft multifocal contact lenses alter accommodation in participants who wear lenses, but most studies use enter-distance lens designs, which is the most commonly used lens for myopia management. Most studies that have evaluated accommodative ability and function while wearing soft multifocal contact lenses have examined center distance lenses. Because center distance lenses are used for myopia management, the interest has been to determine if children maintain normal accommodative function while wearing the lenses. Accommodative function while wearing center near lenses has likely not been studied often because these lens designs are used most in presbyopic populations who have no or waning accommodative ability and are using the lenses, specifically, to account for that accommodative inability.-Knowing how spectacle lenses with add powers effectively treat some binocular vision and accommodative disorders and understanding how center near multifocal contact lenses correct presbyopic vision, it is reasonable to hypothesize that center near multifocal contact lenses may provide a greater therapeutic effect for accommodative and binocular vision disorders than center near designs because the central portion of the lens is the addition power, unlike the center-distance lens designs. This study will aim to determine how accommodative function varies with center distance and center near multifocal contact lenses.
To evaluate dry eye symptoms and contact lens wearing times after a single iLux treatment by evaluating change from baseline in OSDI scores, subjective CLDEQ8 and CL wearing time questionnaires, and meibomian gland secretion scores.
The purpose of this study is to evaluate the impact of community health screening, health education and nutritional intervention on risk factors for cardiovascular disease in a predominantly African American population. The health fair and intervention will take place in a church that typically improves their lifestyle by "giving up for Lent" certain foods or habits. Participation in this nutrition intervention is voluntary and each participant will sign an informed consent along with a waiver. On the waiver, the participant can agree to have all testing performed but can withdraw consent at any time or decide to have only some of the testing. It was hypothesized that a community-based health screening and nutritional intervention will have a positive impact on the participants by: 1. Measuring baseline risk factors 2. Educating them about their individual risk for heart disease 3. Providing education on healthy lifestyle 4. Providing a nutritional intervention for 40 days with home- delivered plant-based meals nutrition that has been shown to lower cardiac risk factors 5. Repeating the risk factor assessment at the end of the intervention, to demonstrate the degree of, if any, reduction in cardiac risk as assessed by the American College of Cardiology/American Heart Association (ACC/AHA) Atherosclerotic Cardiovascular Disease (ASCVD) Risk Calculator 6. Motivating at-risk subjects to seek continued appropriate medical care and to institute more permanent relevant lifestyle changes (e.g., diet, exercise, medication compliance).
This clinical study seeks to evaluate the safety and efficacy of Pro-ocular™1% topical gel in patients with ocular Graft-versus-Host Disease who wear scleral lenses daily. This vehicle-controlled trial will evaluate the investigational drug's effect on signs and symptoms of ocular Graft-versus-Host Disease and on the hours of daily comfortable and serviceable scleral lens wear.
Scleral lenses, customized rigid contact lenses that land on the soft and spongy conjunctival tissue overlying the sclera, will be fitted on 15 subjects with normal ocular surfaces. The purpose of the study is to determine the amount of conjunctival compression caused by the devices and the length of time required for the shape to recover from compression.
The goal of this research is to determine if the Tangible Boost system adequately replenishes the Hydra-PEG coating on the surface of a rigid contact lens. Hydra-PEG is a coating for soft and rigid contact lens, primarily composed of polyethylene glycol-based hydrogel, which is covalently bound to the surface of a contact lens. The Hydra-PEG coating is intended to improve wettability and comfort with contact lenses and is currently FDA approved on a number of contact lenses. For patients with Stevens Johnson Syndrome (SJS) (SS), or Graft versus Host disease (GVHD), diminished efficacy of the Hydra-PEG coating can lead to significant decline in satisfaction with the lenses over time. This is a prospective study to evaluate the efficacy of Tangible Boost, a monthly conditioning solution, to replenish the Hydra-PEG coating on rigid gas permeable contact lenses for patients with SJS, GVHD, and SS. Outcomes from this patient population will be compared to patients with dry eye disease.
The most common reason for contact lens discontinuation is contact lens discomfort. The investigators believe that inflammation plays a role in contact lens discomfort and the use of lifitegrast 5% ophthalmic solution may reduce end of the day contact lens discomfort. This study will enroll 21 contact lens users who will be receiving lifitegrast 5% ophthalmic solution and monitor the contact lens discomfort for a 8 week period while.
The purpose of this prospective study is to evaluate the benefits of using the Bruder Moist Heat Compress in contact lens wearers who report reduced comfortable wear time. This will be done by assessing for improvement in ocular oil gland function and comfortable contact lens wearing time after one month of daily warm compress application. The efficacy of the Bruder Moist Heat Compress applied once will be compared to twice daily application as well as compared to warm compress application using a wash cloth.
This study will compare near clinical oculomotor parameters (heterophoria, vergence ranges, AC/A and accommodative findings) measured when lenses and/or prisms are introduced using three different instruments namely: (i) a standard manual phoropter, (ii) an electronic phoropter and (iii) a wearable adaptive refractor (VisionFit).
This study is a multi-site, 5-visit dispensing, bilateral double-arm parallel group design, double-masked clinical trial using an investigational contact lens and a marketed contact lens. The objective is to evaluate comfort of the contact lenses when worn on a daily wear modality.
This is a multi-site, dispensing, 4-visit, 2-arm parallel group, randomized, double-masked clinical trial using a Vistakon investigational contact lens (test) and a marketed monthly replacement contact lens (control). Each subject will be assigned randomly to either the test or control lens to evaluate the long term safety and efficacy of the investigational contact lens compared to the marketed contact lens over a period of six months of lens wear.
The purpose of this investigation is to evaluate the short-term, clinical performance of two silicone hydrogel daily disposable contact lenses.
This is a pilot evaluation to assess the feasibility of using novel imaging process to characterize lens edge and limbal epithelial thickness profile; lens movement with gaze and blink; and conjunctival microvasculature including fractal analysis of microvascular perfusion maps and blood flow velocity.
This phase II clinical trial studies how well bandage lenses work in treating patients with ocular graft versus host disease. Bandage lenses may be helpful in relieving eye symptoms and damage caused by eye graft versus host disease.
The objective of this study is to evaluate the safety and efficacy of a new investigational cleaning and disinfecting solution (Test) compared to Clear Care cleaning and disinfecting solution (Control) when used by contact lens wearers to clean and disinfect their contact lenses for approximately three months.
The objective of this study is to evaluate the ease of use of a modified, disposable contact lens and suction ring assembly.
This study is being conducted to evaluate Bausch \& Lomb PureVision Multi-Focal contact lenses compared to the Bausch \& Lomb SofLens59 contact lens when worn by adapted soft contact lens wearers on a daily wear basis.