Myopia (Nearsightedness)

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 studying QLM3004, an eye drop medication, to see if it can slow down the worsening of myopia (nearsightedness) in children aged 6 to 12 years. This Phase 3 clinical trial compares three different doses of QLM3004 against a placebo over a treatment period of 96 weeks. The study includes two phases: the first focuses on confirming safety and effectiveness, and the second is an observation period after stopping the treatment, which does not affect the study's main results. Participants receive one of four treatments: low, medium, or high doses of QLM3004 eye drops or a placebo solution. Each dose is applied as one drop in each eye at bedtime daily during the 96-week treatment phase. After treatment ends, children enter a follow-up observation period to monitor their condition without receiving the study medication. During the study, children will have their vision tested regularly using cycloplegic autorefraction to measure changes in their spherical equivalent, which reflects the degree of myopia. Researchers will evaluate safety and monitor any side effects throughout the treatment and observation phases. Participation involves regular visits for assessments over nearly two years to track how the medication affects myopia progression and eye health.

Researchers are evaluating the clinical effectiveness and refractive stability of two procedures, SMILE and SMILE Xtra, in people with myopia. The study compares Small Incision Lenticule Extraction (SMILE) alone versus SMILE combined with Corneal Cross-linking (SMILE Xtra) to see which approach better manages myopia. This research is being conducted by Shanghai Zhongshan Hospital and focuses on adults aged 18 to 50 years with high myopia. Participants will be assigned to receive either the SMILE procedure or the SMILE Xtra procedure. SMILE involves the removal of a small lenticule from the cornea, while SMILE Xtra adds corneal cross-linking to this process to potentially improve stability. The study is non-randomized and does not use masking. Treatments are performed as procedures, and patients will be followed over time to assess outcomes. During the study, participants will have their visual acuity measured at multiple time points: 1 week, 1 month, 6 months, 12 months, 24 months, and 36 months after the procedure. Researchers will monitor how well vision is corrected and how stable the refractive changes remain. The total duration of follow-up is three years, allowing careful assessment of long-term results. Safety and vision quality will be closely observed throughout the study period.

This research aims to compare the effectiveness and remaining refractive error of two types of phakic toric intraocular lenses in patients with moderate to high myopia and astigmatism. The study also evaluates and compares the safety of the EYECRYLTM Phakic Toric lens versus the Visian4 Toric Implantable Contact Lens in this patient group. Phakic intraocular lenses are clear lenses surgically placed in the eye without removing the natural lens, helping to improve uncorrected vision by focusing light correctly on the retina. Participants will be randomly assigned to receive one of two treatments: the Eyecryl Phakic Toric intraocular lens or the Visian4 Toric Implantable Contact Lens. Both lenses are designed to correct myopia and astigmatism and are implanted either in the anterior or posterior chamber of the eye. The study involves surgical placement of these lenses to assess their performance and safety over time. During the study, participants will attend all scheduled follow-up visits to monitor visual outcomes and safety. Researchers will measure the mean residual refractive error six months after lens implantation as the primary outcome. Safety assessments and other evaluations will also be conducted to track the lenses' effects. The study started in October 2021 and is expected to continue until February 2027, with ongoing monitoring of participants' vision and eye health.

Researchers are conducting a randomized controlled trial to compare the clinical effectiveness, biomechanical stability, and optical quality of two procedures for treating myopia: Small Incision Lenticule Extraction (SMILE) and SMILE combined with Corneal Cross-linking (SMILE Xtra). The study aims to understand which procedure better addresses myopia in patients aged 18 to 50 years. This research is sponsored by Shanghai Zhongshan Hospital and focuses on evaluating visual outcomes over a long period. Participants will be randomly assigned to receive either the SMILE procedure or the SMILE Xtra procedure. These are both eye surgeries designed to correct myopia, with SMILE Xtra including an additional cross-linking step intended to improve corneal stability. The study will follow patients for up to 36 months after treatment to assess how well their vision improves and how stable the results remain over time. Throughout the study, participants will have their visual acuity measured at multiple timepoints: 1 week, 1 month, 3 months, 6 months, 12 months, 24 months, and 36 months after surgery. This will help researchers monitor the effectiveness and safety of each procedure. Patients will also be evaluated for any complications or changes in eye health. The total participation duration can last up to three years, with regular follow-up visits to assess and compare outcomes.

Researchers are studying children aged 5 to under 12 years with myopia to evaluate the effects of nightly low-concentration atropine eyedrops and specially designed spectacle lenses on slowing the progression of myopia. The study aims to assess these treatments during peak eye growth years, as previous trials have shown inconsistent results in non-Asian children. This phase 3 randomized clinical trial uses a 2x2 factorial design to compare atropine eyedrops, spectacle lenses with highly aspherical lenslets, their combination, and placebo treatments. Children first complete a run-in phase to show they can follow nightly artificial tear eyedrop use and wear spectacles consistently. Then, they are randomly assigned to one of four groups: 0.05% atropine eyedrops with standard single vision lenses, placebo eyedrops with single vision lenses, placebo eyedrops with highly aspherical lenslets, or atropine eyedrops with highly aspherical lenslets. Treatments are given nightly and spectacle lenses are worn during the 24-month treatment period. After this, children return for a 30-month visit following 6 months of no treatment except single vision spectacles. Participants visit the clinic every six months for 24 months, with a final visit at 30 months. At each visit, researchers measure changes in axial length of the eye (primary outcome) and refractive error (secondary outcome) to assess myopia progression. Throughout the trial, adherence to eyedrops and spectacle wear is monitored. Safety is checked regularly, including pregnancy tests for participants who have started menstruation. This study lasts about 30 months, including treatment, follow-up, and observation periods.

Researchers are evaluating the effectiveness and safety of low-level 650nm red-light irradiation in controlling and preventing myopia in children and adolescents aged 7 to 18 years. This real-world study includes children who are already myopic as well as those with normal vision or mild farsightedness. The study is conducted across multiple hospitals and aims to gather data over three years with follow-ups at six months, one year, and two years. The intervention involves the use of a headworn device that delivers 650nm low-intensity red light to the eyes. This device has been approved for safety and is used by children in everyday settings, not just within the study. The study observes children who are already receiving this red-light treatment, without providing additional interventions, and excludes participants using certain medications like atropine due to safety concerns. Participants will be monitored through regular assessments including measurements of eye axial length and spherical equivalent error at baseline and follow-up visits. Additional eye health measures such as choroid thickness, keratometry, lens thickness, anterior chamber depth, and corneal thickness will also be tracked. The study collects data on these outcomes to understand the red-light treatment's role in myopia control over the study period.

This research aims to evaluate the safety and effectiveness of the Bausch + Lomb Myopia Control Lens in correcting myopia (nearsightedness) and slowing its progression in children aged 8 to 12 years. The study is a multi-center, randomized, parallel, bilateral, investigator-masked trial comparing this new lens to an active comparator lens, the CooperVision MiSight, to better understand options for managing myopia in this age group. Participants will be randomly assigned to wear either the Bausch + Lomb Myopia Control Soft Hydrophilic lens or the CooperVision MiSight one-day soft contact lens. Both interventions are designed for controlling myopia progression. The study involves wearing the assigned lenses daily for a minimum of 10 hours at least six days per week over a 24-month period. The trial is conducted with masking to reduce bias and ensure objective assessment. Children enrolled in the study will undergo various eye tests including measurements of axial length and spherical equivalent refractive error at baseline and after 1 and 2 years to track changes. Researchers will also monitor visual acuity and eye health throughout the study. The total participation duration is 24 months, with scheduled visits for evaluations and safety monitoring to assess the lenses' impact on myopia progression and eye health.

Researchers are evaluating a new form of LASIK called Ray Tracing Guided LASIK by comparing it to three other types of corneal refractive surgery: KeratoLenticule Extraction (KLEx) using the Zeiss Visumax 800 Laser, Wavefront Optimized LASIK (WFO LASIK) using the Alcon EX500 Laser, and Topography Guided LASIK (Contoura LASIK) also using the Alcon EX500 Laser. The study focuses on patients with myopia or myopia with astigmatism and aims to compare visual outcomes across these different technologies in a prospective, randomized design. This study is conducted in three phases, each including at least 44 participants who undergo surgery for refractive correction. In each phase, patients will have one eye treated with Ray Tracing Guided LASIK and the other eye treated with one of the three comparator procedures. The surgeries use specific laser devices and technologies tailored to each method. Participants will receive routine postoperative care and medications as per standard practices. Participants will attend follow-up visits at 1 day, 1 week, 1 month, 3 months, 6 months, and 12 months after surgery. At several visits, including screening and postoperative timepoints, patients will complete questionnaires about their experience. Researchers will measure uncorrected visual acuity at 3, 6, and 12 months as the main outcome. Additional assessments include predictability of vision correction. Retreatments are allowed only after all study visits are completed or the subject has left the study.