Clinical Research Directory

Diabetic Nephropathy, Glycemic Control and Pseudophakic Macular Edema After Cataract Surgery

This retrospective cohort study examines whether the kidney complications of diabetes (diabetic nephropathy) and blood-sugar control before surgery help predict swelling of the central retina, called pseudophakic macular edema (PME), after cataract surgery in people with type 2 diabetes. PME is a common cause of blurred vision after otherwise successful cataract surgery, and people with diabetes are at higher risk. Doctors currently estimate this risk mainly from the HbA1c blood-sugar level and the stage of diabetic eye disease (retinopathy). It is not yet known whether diabetic kidney disease, measured by the urine albumin-to-creatinine ratio (UACR) and estimated kidney function (eGFR), adds independent information about who will develop PME. Using medical records already collected during routine care at Thammasat University Hospital, the investigators will measure central retinal thickness on optical coherence tomography (OCT) scans before uncomplicated phacoemulsification cataract surgery with a lens implant, and again 1 and 3 months afterward. PME is defined as at least a 30% increase in central macular thickness. Patients with and without baseline diabetic nephropathy will be compared, and statistical modeling will identify the best preoperative HbA1c threshold for predicting PME. The results are intended to improve preoperative risk counseling and to help identify diabetic patients who may need closer monitoring after cataract surgery. Because only existing records are used, the study involves no additional visits, tests, or risks for patients.

Postoperative CCT in FECD vs. Non-FECD

This single-centre, prospective, controlled, non-interventional observational clinical study aims to characterize early postoperative corneal thickness behaviour after routine phacoemulsification cataract surgery in eyes with Fuchs endothelial corneal dystrophy (FECD) compared with non-FECD controls, using exclusively standard-of-care perioperative assessments. To compare central corneal thickness (CCT) six weeks postoperatively between FECD and non-FECD eyes, adjusting for baseline (preoperative) CCT. All participants undergo routine phacoemulsification cataract surgery and routine perioperative assessments. Data are collected from the standard-of-care documentation at the following time points: 1. Preoperative baseline visit (routine cataract work-up) 2. Study specific postoperative follow-up at approximately 6 weeks. Each participant will attend a study-specific follow-up visit at 6 weeks postoperatively and contributes study-specific follow-up data up to this time point. The routine clinical parameters assessed (as available per standard practice) include: (A) Medical history / baseline characteristics and documentation of ocular/systemic comorbidities and topical medication. (B) Best-corrected visual acuity (BCVA) (logMAR). (C) Intraocular pressure (IOP) measured by Goldmann applanation tonometry (GAT). (D) Slit-lamp examination (including assessment of corneal clarity/edema and anterior segment findings) with fundoscopy as routinely documented. (E) Central corneal thickness (CCT) measurement using routine clinical devices. All measurements will be performed at a consistent time of day for each patient. (F) Anterior segment optical coherence tomography (AS-OCT) using Casia2. (G) Anterior segment Scheimpflug tomography (Pentacam Oculus AXL). (H) Endothelial cell assessment or Endothelial Cell Count (ECC) examined with NIDEK® CEM-530 Specular Microscope: * Cell Density (CD) or Cell Count. Expressed as Cells/mm² * Coefficient of Variation (CV), represents the degree of variation in cell size (Polymegethism) * Percentage (%) of six-sided (hexagon) cells (HEX) * Standard Deviation (SD) of the average cell area.

Randomized Controlled Trial of the STEIN Protocol: A Neuroplastic Pain Education and Guided Breathing Intervention During Awake Cataract Surgery

This randomized controlled trial evaluates whether a standardized perioperative neuroplastic intervention: the STEIN Protocol (Strategies and Techniques for Enhancing Integration and Neuroplasticity), consisting of pain neuroscience education, guided imagery, and paced breathing, reduces intraoperative analgesic and anxiolytic requirements. Secondary outcomes include patient-reported pain, anxiety, satisfaction, and postoperative recovery following cataract surgery. Reduced intraoperative sedative and analgesic requirements may reflect improved patient comfort and autonomic regulation while minimizing medication-related adverse effects.

Evaluation of Visual Outcomes, Complications, and Neuroadaptation Following Bilateral Implantation of enVista Envy Trifocal Intraocular Lenses

The enVista Envy intraocular lens (IOL) manufactured by Bausch + Lomb is a new multifocal intraocular lens based on diffractive optics. It was registered with the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products in September 2025. The lens also bears the CE mark, indicating that it is approved for marketing and use within the European Union. Its innovative design is based on a smooth, continuous transition between diffractive rings, allowing patients to achieve excellent visual quality at far, intermediate, and near distances while reducing the incidence and severity of unwanted photic phenomena such as glare and halos. Thanks to this technology, patients may achieve better uncorrected visual acuity, reduced dependence on spectacles, and faster neuroadaptation. The Second Department of Ophthalmology is the first center in Poland to be offered participation in a clinical study evaluating the safety and effectiveness of the enVista Envy IOL. The planned study will provide the first clinical experience with this lens in Poland and contribute to expanding knowledge regarding modern intraocular lens technologies. Twenty patients will be selected according to predefined inclusion and exclusion criteria. Preoperative assessment will include a comprehensive ophthalmic examination and IOL power calculation. Cataract surgery will be performed using bimanual MICS (Micro-Incision Cataract Surgery) phacoemulsification. Surgery in the fellow eye will be performed one month after the first procedure. Before surgery and during follow-up visits at 1, 3, and 6 months postoperatively, the following assessments will be performed: routine ophthalmic examination, intraocular pressure (IOP) measurement, visual evoked potentials (VEP), monocular and binocular uncorrected distance visual acuity (UDVA), distance best-corrected visual acuity (DBCVA) at 4 meters, intermediate visual acuity (66 cm) and near visual acuity (40 cm), both corrected and uncorrected, monocularly and binocularly (logMAR charts), binocular contrast sensitivity testing, and defocus curve assessment. Intraoperative and postoperative complications, quality of vision (using the standardized Quality of Vision Questionnaire \[QoV\] and the Near Activity Vision Questionnaire \[NAVQ\]), speed of neuroadaptation, spectacle independence, and the occurrence of photic phenomena such as glare and halos will also be analyzed.

Can Tailored Surgical Incisions Reduce Refractive Error and Dependence on Glasses After Cataract Surgery?

Astigmatism is a common cause of continued dependence on glasses after cataract surgery and may lead to patient dissatisfaction with surgical outcomes. As the corneal curvature is the main source for astigmatism after cataract surgery, our aim is to investigate whether postoperative astigmatism can be reduced by tailoring the location of surgical incisions according to the curvature of the cornea. We also wish to investigate whether this in turn reduces the need for glasses following cataract surgery. In the planned study, one group of patients with cataracts and concurrent corneal astigmatism will undergo surgery using customized incision placement, while a control group will be operated on using standard incision placement without consideration of corneal astigmatism. Astigmatism will be measured before surgery and again at 3 and 12 weeks postoperatively. We will also assess how tailored incisions affect corneal biomechanics and shape, as well as measure visual quality and the need for glasses during daily activities before and after surgery. Approximately 160,000 cataract procedures are performed annually in Sweden. Around 40% of these patients (64,000 individuals) have astigmatism greater than 1 diopter and could potentially achieve improved surgical outcomes based on the results of this study. The method is cost-effective and associated with a low risk of complications compared to other approaches for reducing astigmatism.

Vision Center Determinants of Cataract Follow-Up in Rural India

Cataract remains the leading cause of avoidable blindness in India despite substantial expansion of surgical services over the past two decades. While surgical coverage has improved, optimal visual outcomes depend on effective post-operative follow-up, which remains inconsistent across decentralized Vision Center-based systems, particularly in rural and semi-urban settings. Routine program data show wide variation in post-operative cataract follow-up compliance among Vision Centers operating within similar organizational and geographic contexts, suggesting the influence of facility-level determinants. This phased mixed-methods implementation study aims to identify facility-level factors influencing post-operative cataract follow-up compliance and to develop an evidence-based framework to strengthen follow-up systems. Phase 1 will involve retrospective analysis of three years of integrated Health Management Information System- Vision Centre Management Information System (HMIS-VCMIS) data from approximately 120 Vision Centers to establish empirical benchmarks and classify centers as high- or low-performing. Structured facility assessments and qualitative interviews with Vision Center staff, program managers, and post-operative patients will be conducted to identify operational practices, workflows, and contextual factors associated with follow-up performance. Phase 2 will focus on co-design, pilot testing, and early implementation of a Follow-Up Strengthening Intervention Framework in selected low-performing Vision Centers. The intervention will include standardized counselling workflows, follow-up tracking and reminder systems, role clarification, supervisory feedback mechanisms, and peer-learning support from high-performing centers. Changes in follow-up compliance will be monitored using routine data over a 12-month implementation period, alongside process evaluation to assess feasibility, fidelity, and acceptability. Findings from this study will generate practical evidence to strengthen post-operative cataract follow-up systems and inform scalable quality improvement strategies within decentralized Vision Center networks.