Scleritis is an inflammatory condition affecting the white outer layer of the eye, often studied through clinical trials that explore various treatment options and their effectiveness. Trials commonly evaluate the safety and efficacy of medications a...
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Found 13 Actively Recruiting clinical trials
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Researchers are investigating the effects of an investigational cold treatment device called ETX-4143 on the eyes surface anatomy and inflammatory response in people with chronic ocular surface pain COSP. This study aims to understand changes to corneal surface nerves and inflammatory mediators after treatment, while also evaluating the safety of this cooling device. The study involves detailed imaging and tear sample analysis to learn more about the condition and treatment impact. The ETX-4143 Device is a handheld cooling tool containing a frozen mixture that cools metallic probes touching the eyes conjunctival surface without direct contact with the frozen mixture. Before treatment, local anesthesia and a corneal shield are applied to protect the eye. Participants will receive a 4-minute cold treatment to the worse eye using this device. This single-center study will treat 5 adults with chronic ocular surface pain and follow them for 12 weeks. Participants will be screened for chronic ocular surface pain and will complete weekly eye pain questionnaires for 12 weeks. Clinic visits at 2, 6, and 12 weeks after treatment will include corneal surface imaging and tear sample collection. Both eyes will be assessed with confocal microscopy and tear osmolarity tests, using the untreated eye as a control. The main measurement is corneal nerve imaging analysis over the 12-week period, alongside safety monitoring by the medical team.
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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 studying the relationship between clinical factors and the occurrence of adverse drug reactions in hospitalized patients who receive tropicamidephenylephrine 8 mg50 mgmL. 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 tropicamidephenylephrine 8 mg50 mgmL. 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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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.
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Researchers are studying the effects of two topical corticosteroid treatments, Hydrocortisone and Dexamethasone, in adults who wear ocular prostheses and experience significant discomfort from inflammatory secretions. This trial aims to determine the value of these anti-inflammatory treatments compared to a placebo in reducing symptoms and improving comfort for these patients. The study is a prospective, randomized, single-blind clinical trial designed to provide controlled evidence for treatment effectiveness. Participants will receive three different treatments in a cross-over design Hydrocortisone eye drops, Dexamethasone eye drops, and a tear substitute Povidone used as a placebo. Each treatment period lasts 14 days, separated by one-month wash-out phases. The treatments are administered as one drop four times a day. This design allows each participant to receive all treatments in sequence, helping compare their effects individually. During the study, participants will be evaluated at multiple time points before, during, and after each treatment phase. Researchers will use self-rating scales to measure secretion symptoms and assess conjunctival inflammation through clinical scores. They will also monitor secretion frequency, color, amount, and viscosity, as well as quality of life using a specific questionnaire adapted for prosthesis wearers. The total study duration per participant is about 3.5 months, including treatment and wash-out periods, with regular visits for assessments and monitoring.
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This clinical trial evaluates pain and inflammation control after vitreoretinal surgery, focusing on patients aged 18 and older undergoing pars plana vitrectomy for macular hole, epiretinal membrane removal, or vitreomacular traction. The study compares two treatments a corticosteroid insert and topical steroid eye drops, aiming to improve postoperative management. The rationale is that topical steroids rely on patient adherence and may vary in effectiveness, while the insert provides continuous drug delivery over 30 days. Participants are randomly assigned to one of two groups. One group receives the DEXTENZA4 intracanalicular dexamethasone insert placed via the lower eyelid canaliculus immediately after surgery, which releases medication automatically for up to 30 days. The other group uses prednisolone acetate 1% eye drops, applied four times daily for the first week after surgery. Both groups also receive standard topical antibiotic treatment. The study is conducted in a parallel design with single masking. During the study, participants are monitored at days 1, 3, 7, 14, and 21 after surgery. Researchers assess inflammation control, pain levels using a visual analog scale, inflammation by anterior segment OCT, visual acuity changes, rebound inflammation, rescue treatment use, and any adverse events. Postoperative communication may include telephone or electronic messaging. The primary outcome is inflammation control at day 14, with follow-up continuing through day 21. Total participation lasts about three weeks after surgery.
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Healthy Volunteer
Researchers are evaluating whether plain language summaries created by artificial intelligence can help adults better understand their eye doctors notes. This study focuses on patients receiving eye care at the Jules Stein Eye Institute and aims to improve communication between patients and healthcare providers by making medical information clearer. The trial compares usual medical notes to notes supplemented with AI-generated summaries that explain complex eye care information in simple, everyday language. Participants are randomly assigned to one of two groups one group receives the standard ophthalmology notes alone, while the other group receives these notes plus an AI-generated plain language summary reviewed by an ophthalmologist for accuracy. The AI system operates securely within UCLAs network and uses a customized large language model to generate clear explanations of medical details. No data is sent outside the secure environment, ensuring participant privacy. During the study, participants complete surveys immediately after their clinic visit to assess how well they understood their diagnosis, treatment, and follow-up plans. About one week later, they receive a follow-up phone call to further evaluate clarity and retention of information. Researchers also analyze patient comprehension scores and satisfaction, as well as time efficiency for ophthalmologists and other related outcomes. Data is securely stored and monitored throughout the trial, which is expected to last until June 2026.
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Healthy Volunteer
Rare Eye Diseases REDs affect the cornea, the transparent outer layer of the eye, disrupting its complex structure and leading to problems such as non-healing wounds, inflammation, scarring, and vision loss. This project aims to study seven different REDs, including genetic and autoimmune conditions, by analyzing gene and protein expression in patient tissues and fluids. It seeks to understand disease mechanisms and evaluate novel and repurposed drug targets to improve treatments for these rare conditions, which currently have limited effective options. The study involves recruiting adult participants with REDs and healthy controls. It collects blood, tear fluid, and conjunctival cell samples to analyze gene and protein levels linked to the diseases and the drugs being tested. Participants undergo ophthalmological exams, complete questionnaires about eye symptoms and pain, and provide biological samples through non-invasive procedures. The research compares expression patterns between patients and controls to identify biomarkers and correlations with clinical signs. Participants will attend an inclusion visit where clinical assessments, imaging, and sample collections occur. Researchers will monitor gene and protein expression levels to better understand REDs and the effects of potential treatments. The study involves no drug administration but focuses on validating targets for future therapies. Participation includes questionnaires, eye exams, and sample collection, with total involvement lasting the duration of study visits around the inclusion timepoint.
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Researchers are studying people with diagnosed, undiagnosed, or suspected eye diseases to better understand these conditions and how they are inherited. The study also includes first-degree relatives without symptoms who agree to provide blood samples for genetic testing. The goal is to collect clinical data and specimens from participants receiving standard eye care, helping to build resources for future research and evaluate current treatments. Participants may have between 1 and 12 visits annually for up to 5 years, depending on their eye condition. Each visit lasts about 4 hours and can include medical and family history reviews, physical and eye exams, eye photography, specialized eye movement and electrical tests, and imaging with dye injections. Samples from the eye surface, blood, skin, tears, urine, saliva, stool, or hair may be collected. Some children may have exams done under anesthesia. Treatments such as medications, eye drops, injections, laser therapy, or surgery may be given during these visits. During the study, participants undergo various assessments including eye exams, photography, and specialized tests like electroretinography and fluorescein angiography. Researchers monitor responses to standard treatments through these clinical evaluations. The study involves ongoing data collection and specimen gathering to understand the natural history of eye diseases and treatment effects. Participation may last up to 5 years, with regular follow-up visits tailored to the participants condition.
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Researchers are evaluating the impact of regularly using Systane COMPLETE in patients with mixed dry eye who are planning to undergo cataract surgery. The study aims to see if this treatment can improve the accuracy of predicting residual astigmatism after surgery. Participants are adults aged 20 to 85 years with normal cognitive function who require cataract surgery with intraocular lens implantation. Participants will use Systane COMPLETE eye drops, applying 1 to 2 drops four times daily in both eyes for 1 to 2 months before surgery. The study includes a screening visit 1 to 2 months before surgery where demographic information, preoperative assessments, and dry eye evaluations are performed. Measurements of the cornea will be taken using specialized devices to monitor the ocular surface and detect irregularities. Seven days before surgery, participants will have repeat eye exams and biometry measurements to guide lens selection. On surgery day, participants will undergo cataract surgery with intraocular lens implantation, and medication use will be monitored through returned bottles and diaries. During the study, participants will complete questionnaires such as the OSDI Dry Eye Questionnaire and undergo vision and corneal surface assessments. Measurements include biometry and corneal topography, as well as non-invasive tear break-up time tests. These evaluations will occur at screening and pre-operative visits to track changes in the ocular surface. Compliance with treatment will be checked at surgery. The study will last until the end of 2027, focusing on optimizing the ocular surface to improve surgical outcomes for dry eye patients undergoing cataract surgery.
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