Cataract

Eye disease affects billions worldwide, causing vision problems that impact daily life and productivity. This research focuses on eye health in coastal Bangladesh, a region with high poverty, limited healthcare access, and environmental risks that increase eye disease prevalence. The study evaluates a community-based eye screening program using Artificial Intelligence (AI) to detect conditions like diabetic retinopathy, glaucoma, cataracts, and age-related macular degeneration, aiming to improve early diagnosis and care in underserved areas. The program offers a twelve-step eye screening process supported by AI-assisted fundus imaging, combined with partnerships among local organizations and healthcare providers. Screening includes community outreach, vision tests, blood pressure and glucose checks, optometrist evaluations, and selective AI imaging for higher-risk individuals based on age, diabetes, hypertension, or symptoms. Patients diagnosed with severe cataracts are offered surgery through local or regional services. The approach integrates data collection, AI analysis, clinical examinations, counseling, and referrals to support comprehensive eye care. Participants aged 35 and older from the Char Fasson sub-district undergo screening and follow-up over several months. The study collects demographic, clinical, and imaging data securely, with informed consent for storing fundus images. Researchers monitor the number of individuals screened and the prevalence of eye diseases. Safety and data privacy are maintained using encrypted systems and compliance with ethical standards. The program's feasibility, cost, and effectiveness in improving eye care accessibility are assessed throughout the study.

This research aims to compare surgical outcomes and parameters between cataract surgeries performed using a new 3D imaging system called the NGENUITY4 3D Visualization System and the current standard binocular microscope in patients with high myopia. The study focuses on how differences in depth of field between these two systems affect factors during surgery and the results, including potential complications. Participants will have high myopia and significant cataracts requiring surgery. Participants will be randomly assigned to one of two groups: one group will undergo cataract surgery using the standard binocular microscope, while the other group will have surgery using the Alcon NGENUITY4 3D Visualization System. During surgery with the NGENUITY system, the surgeon wears 3D glasses and views the operation on a 3D screen. Both groups receive standard cataract extraction with phacoemulsification and intraocular lens implantation. Throughout the surgery, researchers will measure how often and how far the microscope focus is adjusted, the distance needed to focus from the corneal surface to the lens capsule, total operation time, and ultrasound energy used. After surgery, participants will be followed for three months to monitor vision, eye pressure, and any complications. These assessments will occur on day 1, week 1, month 1, and month 3 after surgery to evaluate safety and effectiveness of the two visualization methods.

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 two commercially available trifocal toric intraocular lenses to compare their clinical outcomes and patient satisfaction in people undergoing cataract surgery. The main goal is to compare the distance-corrected intermediate visual acuity provided by these lenses. Additionally, the study aims to assess and compare the safety of the two trifocal toric intraocular lenses designed to correct astigmatism and improve vision at near, intermediate, and distance ranges. Participants will be randomly assigned to receive one of two types of trifocal toric intraocular lenses: Optiflex TRIO or AcrySof IQ PanOptix. Both lenses are single-piece, posterior chamber foldable intraocular lenses with advanced aspheric optics and a trifocal design intended to reduce dependence on glasses. The Optiflex TRIO features a refractive-diffractive trifocal toric optic with a square edge design, while the AcrySof IQ PanOptix has a diffractive trifocal optic with a toric component. Each participant will receive one of these lenses based on randomization during cataract surgery. During the study, participants will be monitored for visual acuity outcomes, focusing on binocular distance-corrected intermediate vision at six months after lens implantation. Researchers will also track patient satisfaction and safety throughout the study period. The study includes preoperative assessments such as corneal topography or keratometry to measure astigmatism and will involve follow-ups to evaluate visual performance and any adverse effects. The total duration of participation varies but includes at least a six-month follow-up for outcome measurement.

Researchers are conducting a prospective, randomized, multicenter study to compare three types of intraocular lens (IOL) implantations in adults with cataracts aged 40 years and older. The study is designed with two stages: an initial three-arm enrollment followed by a head-to-head comparison based on data from the first stage. The trial evaluates vision outcomes after cataract surgery using different Clareon lenses to better understand their effects on visual acuity and patient satisfaction. The study involves three treatment groups: bilateral Clareon PanOptix IOL implantation, bilateral Clareon PanOptix Pro IOL implantation, and a mixed approach with Clareon PanOptix Pro in one eye and Clareon Vivity in the other. Participants will receive their assigned lens implantations during cataract surgery. The study is masked so that subjects and vision assessors do not know which lenses are implanted to ensure unbiased evaluation. Participants will be monitored for at least three months after surgery, during which several visual acuity measurements will be taken, including corrected distance, intermediate, and near vision under different lighting conditions. Patient-reported outcomes about visual disturbances and satisfaction with the lenses will be collected through questionnaires. The study also measures contrast sensitivity, refractive outcomes, and pupil size. Safety and vision improvements will be regularly assessed throughout the follow-up period.

This research aims to assess the safety of the Helix Surgical System when used alongside cataract surgery and to gather early evidence on its effectiveness in lowering intraocular pressure (IOP) in people with mild to moderate primary open-angle glaucoma (POAG) and cataracts. The study focuses on individuals diagnosed with these eye conditions to better understand the potential benefits and risks of this device. The Helix Surgical System is a handheld device designed to improve eye fluid drainage by viscodilating up to 360 degrees of Schlemm's canal and collector channels, and it also allows an intracanalicular scaffolding procedure to restore the eye's aqueous outflow system. Participants will undergo cataract surgery combined with the use of this system to evaluate its impact on IOP and medication use. Participants will be monitored over time with assessments including measurement of intraocular pressure at three months after surgery to determine if there is at least a 20% change from baseline. Researchers will also track changes in the average number of ocular hypotensive medications used. Safety and effectiveness will be evaluated through regular check-ups and eye exams during the study period, which is expected to last several months after the procedure.

Researchers are evaluating the effects of MELT-300 on procedural sedation in adults undergoing cataract extraction with lens replacement (CELR). This Phase 3 clinical trial aims to compare MELT-300 with a placebo and an active comparator, sublingual midazolam, to assess the contribution of ketamine in the combined drug product. The study focuses on the effectiveness and safety of MELT-300 during and after cataract surgery. Participants will be randomly assigned to one of three groups: MELT-300 (a sublingual tablet containing 3 mg midazolam and 50 mg ketamine), midazolam alone (3 mg sublingual tablet), or a placebo tablet. They will receive a single dose of the assigned medication approximately 30 minutes before surgery without food or water. The surgery will be performed under topical anesthesia, and the study medication effects will be assessed before, during, and after the procedure. Participants will be admitted on the day of surgery and monitored throughout. Researchers will assess sedation levels, the need for additional sedation or pain medication, and the ability to complete surgery. Safety will be tracked through adverse event monitoring, vital signs, and physical exams at baseline, during surgery, and up to three days after medication. The primary outcome measured is the percentage of participants achieving successful procedural sedation at various time points on the day of surgery.

Researchers are studying adaptive optics, a new imaging technology, to improve the diagnosis, treatment, and management of eye diseases affecting the retina. The study involves both people over age 12 with various eye diseases and healthy volunteers over age 12 to compare retinal images between diseased and normal eyes. The goal is to find better ways to detect retinal problems earlier than current methods allow. Participants will undergo eye exams including pupil dilation and adaptive optics imaging, where they look into a special instrument that captures high-resolution images of the retina. Some may also have additional tests like perimetry, color vision tests, and electroretinograms using numbing eye drops and special contact lenses. This observational study plans to enroll a total of 600 participants over five years, with 350 having eye diseases and 250 healthy volunteers. During the study visits, participants will provide medical and eye history and information about their medications. Researchers will assess the adaptive optics images qualitatively and quantitatively to compare normal and diseased retinal states. The study includes regular eye exams and imaging assessments, with the primary outcome focused on evaluating these adaptive optics images. Participation involves one or more visits, with detailed eye examinations and imaging procedures to monitor retinal health.

Researchers are evaluating a new handheld optical coherence tomography (OCT) device designed to automatically align with the eye to capture detailed retinal images. This pilot study aims to assess this advanced imaging technology in healthy adult volunteers, adult patients, and pediatric patients with eye and retinal diseases, addressing current challenges in imaging uncooperative patients, especially children. The study is observational and led by Duke University, focusing on improving imaging speed, alignment, and data quality for retinal assessment. The study uses a Swept Source OCT system with enhanced hand-held probe technology that auto-aligns to the patient’s eye and detects image quality in real time, automatically saving optimal images. Participants include 20 healthy adults, 20 adult patients, and 10 pediatric patients from ophthalmology clinics. Imaging will be performed during clinical visits, with up to four single imaging sessions over two years to capture detailed retinal structure and blood flow. Participants will undergo retinal imaging using the handheld OCT device during their clinical visits. Researchers will analyze images for retinal microanatomy abnormalities and retinal thickness at specific eye regions, collecting data securely for further analysis. The study will monitor outcomes over multiple sessions for up to two years, with no known risks reported from prior handheld OCT use. The total participation duration depends on the number of imaging sessions completed within the study timeframe.

Researchers are evaluating how anxiety traits affect pain, anxiety levels, and satisfaction with anesthesia in patients undergoing cataract surgery using topical anesthesia. The study explores the use of oral anti-anxiety medication, Xanax, compared to a placebo to improve comfort during this common surgery. The aim is to better understand how anxiety and sedation impact the surgical experience and patient satisfaction. Participants will be randomly assigned in a double-blind manner to receive either Xanax or a placebo 30 minutes before their cataract surgery. Anxiety levels will be assessed using the Beck Anxiety Inventory (BAI) and the State-Trait Anxiety Inventory (STAI) questionnaires before and after medication, as well as following surgery. The study focuses on cataract surgery performed with phacoemulsification and intraocular lens implantation under topical anesthesia. During the study, patients will complete anxiety questionnaires at recruitment, before surgery, and after surgery. Pain levels and satisfaction with anesthesia will be measured on the day of surgery and the following day. Researchers will monitor surgical procedures and anesthesia effects closely. The study lasts from recruitment through postoperative follow-up, including assessments up to 1 to 3 months after surgery to analyze anxiety and satisfaction outcomes.