Age-Related Farsightedness (Presbyopia)

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.

Researchers are evaluating a new algorithm-assisted subjective refraction software designed specifically for children aged 6 to 12 years. This study aims to compare the accuracy of two versions of this software, each used with Vision-S™ and Vision-R™ phoropters, against the conventional subjective refraction method performed manually with the Vision-R™ phoropter. The research focuses on improving the standardization and accuracy of refraction assessments in children. The study has two phases: Phase A will validate the first version of the Kids refraction software (vA) and Phase B will evaluate the second version (vB), which includes additional steps to help manage the child's attention and cooperation. Participants will undergo subjective refraction tests using both software versions with Vision-R™ or Vision-S™ devices, as well as conventional subjective refraction with Vision-R™. Measurements will be taken under non-cycloplegic conditions, with some assessments also performed under cycloplegic conditions. Participants will have their visual acuity and refraction results assessed multiple times, including Sphere, Cylinder, and Axis measurements, starting from Day 1 and continuing up to 7.5 months. The study includes comparisons between non-cycloplegic and cycloplegic refraction results using various devices. Researchers will monitor visual acuity throughout the study to evaluate the software's performance. The total duration of participation for each child will be approximately 7.5 months.

Researchers are evaluating self-reported quality of vision and quality of life in physicians and medical students undergoing LASIK, SMILE, and PRK eye surgeries. The study focuses on understanding how these procedures affect vision and daily life over a 12-month period. Participants must meet specific medical and ophthalmic criteria to be considered suitable candidates for these refractive surgeries. Participants will have a thorough eye exam including slit lamp and dilated fundoscopic examinations, as well as computerized videokeratography before enrollment. Those eligible will undergo bilateral simultaneous LASIK, SMILE, or PRK surgery. The Quality of Vision Questionnaire is used to assess outcomes before surgery and at 3 and 12 months post-operation. Standard post-operative care includes topical antibiotics and anti-inflammatory eye drops as appropriate. Participants will attend visits before surgery, on the day of surgery, and at 1 day, 1 month, 3 months, and 12 months afterward, with additional visits as needed. The study measures include self-reported vision quality and quality of life, predictability of vision correction, changes in visual acuity, and contrast sensitivity. Follow-up is conducted under the care of the treating physician to monitor safety and progress for up to one year.

Researchers are evaluating the wearing experience of the A.M.L. series of lenses in children with myopia aged 6 to 12 years. The study aims to find out how quickly and effectively children adapt to these lenses and the proportion who adapt within 4 to 6 days. This research responds to the rising prevalence of myopia in children and focuses on comfort, adaptation, and user satisfaction beyond just vision correction. In this one-arm, interventional study, 40 myopic children will wear the A.M.L. series of lenses continuously for two weeks. Participants will have scheduled visits to assess their adaptation and comfort at day 4 to 6, at one week, and at two weeks. The study focuses solely on this device without a comparison group. During the study, participants will be monitored for adaptation by checking if they experience any symptoms while wearing the lenses. Visual comfort, wearing time, and overall satisfaction will be evaluated using questionnaires at multiple time points. The main outcome is the proportion of children who adapt within 4 to 6 days without symptoms. The total participation lasts two weeks with follow-up visits to track progress and user experience.

Researchers are evaluating the clinical use of advanced eye imaging tools such as optical coherence tomography (OCT), retinal function imager (RFI), slit-lamp biomicroscopy (SLB), and pattern electroretinogram (PERG) in both diseased eyes and healthy controls. The study includes people with various eye-related conditions including multiple sclerosis, dry eye syndromes, diabetic retinopathy, presbyopia, myopia, and dementia. The study aims to better understand eye conditions through detailed imaging and functional assessments. The study has two phases. The first phase is observational, where participants undergo imaging and eye examinations without treatment. The second phase is interventional, where participants take an over-the-counter medical food called Ocufolin daily for six months with a gradually increasing dose. Participants in the interventional phase take one capsule each morning for one week, two capsules each morning for the second week, and three capsules each morning for the remaining four and a half months. Participants will be followed and assessed for up to two years. Eye structure and function will be measured using OCT, optical coherence tomography angiography (OCTA), functional slit-lamp biomicroscopy (FSLB), and retinal function imager (RFI). Measurements include retinal microstructure, retinal and conjunctival blood flow, corneal thickness, and tear film thickness. The study includes regular imaging and visual acuity testing, with the goal of understanding changes in eye health and vascular function over time.

This research aims to verify the accuracy of the EpiMaster application software's predictions for post-operative results in patients undergoing PTK-PRK refractive treatments. The study focuses on people with myopic or myopic and astigmatic refractive errors and compares predicted outcomes with actual clinical data after surgery. This observational study does not use the EpiMaster software during treatment but collects data to assess its prediction capabilities. Participants will receive PTK-PRK refractive treatment following routine clinical practice using the CZM MEL 90 Excimer Laser. The study does not involve any experimental procedures or interventions beyond standard care. The aim is to gather postoperative data to evaluate how well the software predicts the refractive outcomes, considering epithelial remodeling. During the study, participants will undergo follow-up visits and examinations as part of their routine care and data collection. Researchers will measure the difference between the spherical equivalent (SE) measured after surgery and the SE predicted by the EpiMaster software, with the primary outcome assessed at six months post-treatment. Participants need to agree to attend all follow-ups and understand the study information before enrolling. The study is expected to continue until mid-2027.

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.

Researchers are evaluating the comfort, vision, and satisfaction of the TOTAL30 Multifocal Toric contact lenses in adults who have previously worn reusable silicone hydrogel toric contact lenses and are now presbyopic. The study focuses on presbyopic adults aged 18 to 40 who have astigmatism and are transitioning to these new contact lenses. The trial aims to determine whether these lenses provide good visual acuity, comfort, and willingness to continue use after one month of wear. Participants will be refit with the TOTAL30 Multifocal Toric contact lenses, which are monthly silicone hydrogel lenses designed to provide comfort throughout the day. The study involves wearing the lenses daily for at least 13 hours, without overnight use, and includes assessments at Day 1, Day 14, and Day 29 via text message to track comfort and vision. The study is prospective and focuses on those currently using reusable silicone hydrogel toric lenses, with astigmatism between 0.75 and 2.50 diopters in each eye. During the study, participants will undergo evaluations including visual acuity testing and completion of the Contact Lens Dry Eye 8 questionnaire to measure comfort levels. Researchers will collect comfort ratings on Days 1, 14, and 29 and monitor how well participants adapt to the lenses. The main outcome is visual acuity after one month of wear, along with comfort and dryness scores. The total participation period includes one month of lens wear and monitoring, with the study ending in September 2026.

Researchers are evaluating whether providing free near and distance glasses to older adults in Hyderabad, India, aged 60 years and above, with under- or uncorrected vision problems can improve their quality of life and slow cognitive decline. This mixed-method study combines a randomized controlled trial (RCT) with a qualitative component to understand the cultural context and lived experiences of participants with reduced vision. The study also aims to assess the impact of vision correction on reducing falls, depression, social isolation, and physical activity over a period of 36 months. Participants are randomly assigned to one of two groups. Those in the intervention group receive free spectacles for near and/or distance vision at the start of the study, with options to choose from 20 frames. They will have annual eye exams and refractions to adjust or replace glasses as needed. The control group receives prescriptions and free glasses only at the end of the study. Cataract surgery is provided at no cost for those recommended during follow-ups. Annual assessments continue for three years, including home visits for participants unable to attend clinic visits. During the study, participants undergo evaluations of cognitive function, quality of life, visual functioning, physical activity, depression, social interactions, cost of care, and number of falls. Researchers use various questionnaires and cognitive tests at baseline and every 12 months until 36 months. The study also tracks compliance with spectacle use and cataract surgery outcomes. Safety and follow-up data, including reasons for any loss to follow-up, are carefully recorded to support comprehensive analysis of the intervention's effects.

Researchers are evaluating the comfort and vision provided by the TOTAL30 Multifocal contact lenses during extended wear in adults aged 40 and older who currently wear soft multifocal lenses. This single-arm, observational study aims to understand how well these lenses perform over long wear times, focusing on subjective comfort and vision quality. The study also uses surveys and visual acuity tests to explore the real-world experience of lens wear in people with myopia, presbyopia, and astigmatism. Participants will wear the TOTAL30 Multifocal lenses and provide feedback on their comfort and vision at 10, 12, 14, and 16 hours of wear on Days 1, 7, 14, and 30. The study involves three site visits to assess vision using logMAR visual acuity tests at distance and near. In addition to these visits, participants will complete at-home surveys that collect real-time data on lens comfort and vision, including the CLDEQ-8 survey for subjective comfort evaluation. Throughout the study, participants are expected to wear the lenses for 13 hours daily and up to 16 hours on days when surveys are collected. Researchers will monitor patient-reported comfort and vision quality over the 30-day period. The study includes regular assessments through questionnaires and vision tests to measure outcomes related to lens comfort and visual performance. Participants must have a smartphone to receive survey notifications and must attend all scheduled visits and respond promptly to surveys.