Clinical Research Directory

Emerging Indications for Hyperbaric Oxygen Treatment

This study will evaluate the effectiveness of hyperbaric oxygen therapy (HBOT) on treating emerging indications (i.e., conditions that have shown to potentially benefit from HBOT) using the Multicenter Registry for Hyperbaric Oxygen Treatment. The study team aims to collect ongoing data on how well HBOT treats these emerging indications, and to add these data to the growing HBO Registry. The research team hypothesizes that HBOT will result in improvements of the condition of the various emerging indications.

Air-Dried Human Amniotic Membrane Terminally Sterilized by Gamma Irradiation for Multidisciplinary Clinical Application

This prospective interventional clinical study aims to evaluate the safety and therapeutic efficacy of air-dried human amniotic membrane (hAM) sterilized using different doses of gamma irradiation for regenerative medical applications. Gamma irradiation is employed as a terminal sterilization method to ensure microbiological safety while preserving the structural integrity and biological properties of the membrane. Within the same clinical protocol, the gamma-sterilized hAM will be applied to two distinct patient cohorts: individuals with diabetic foot ulcers (DFU) and patients with corneal ulcers. In the DFU cohort, the membrane will be used as a biological dressing to promote wound closure, enhance granulation tissue formation, reduce infection risk, and accelerate epithelialization. In the corneal ulcer cohort, the membrane will be applied to support corneal surface reconstruction, promote epithelial healing, reduce inflammation, and prevent complications. Participants in both cohorts will be monitored for clinical outcomes including rate of wound healing, time to complete epithelialization, infection rate, pain reduction, corneal re-epithelialization, and overall tissue regeneration quality. Clinical outcomes will be compared among membranes sterilized at different gamma irradiation doses to determine the optimal dose that ensures effective sterilization while maintaining biological activity and therapeutic performance.

Development of a Mobile Terminal-Based Intelligent Detection System for Multiple Anterior Segment Diseases of the Eye

This is a multi-center, cross-sectional study evaluating a smartphone-based artificial intelligence (AI) system for anterior segment eye disease screening. The system is designed to identify 16 clinically important anterior segment conditions from images captured using a standard Android smartphone. A core design feature of the system is that all image analysis is performed entirely on the smartphone itself, without requiring internet connectivity or cloud-based server infrastructure. The study is motivated by a structural challenge in the deployment of medical AI: systems that depend on cloud infrastructure for inference are non-functional in settings without reliable internet access, which disproportionately excludes populations in low-resource regions where the burden of preventable eye disease is highest. This study evaluates whether an on-device AI system, designed with operational constraints as a primary engineering objective, can deliver clinically acceptable diagnostic performance while remaining operable under real-world connectivity limitations. The study comprises five evaluation components. First, the diagnostic performance of the AI system is benchmarked against board-certified ophthalmologists of varying seniority on a standardized set of smartphone-captured anterior segment images. Second, the usability of the system is evaluated among non-medical users who perform self-administered screening with minimal instruction, with per-screening time recorded across consecutive attempts to characterize the learning curve. Third, a head-to-head field trial directly compares the on-device AI system against a functionally equivalent cloud-based deployment of the same model architecture across key operational dimensions including screening duration, diagnostic performance, and user acceptability. Fourth, population-level screening is conducted among consecutively enrolled community residents at two low-resource sites, with per-disease sensitivity and specificity calculated against reference-standard slit-lamp examinations. Fifth, pre-specified health-economic and environmental analyses compare the two deployment modalities in terms of per-person screening cost, cost-effectiveness, per-inference electricity consumption, and projected carbon emissions at scale. The reference standard for all diagnostic comparisons is slit-lamp biomicroscopic examination performed by board-certified ophthalmologists. The study is designed and reported in accordance with the DECIDE-AI reporting guideline for early-stage clinical evaluation of AI-driven decision-support systems.

Comparing Two Surgical Methods to Prevent Pterygium Regrowth

This study compares two surgical techniques for preventing the regrowth of a pterygium, a non-cancerous growth on the eye. After surgically removing the pterygium, surgeons will cover the area with either a flap of nearby tissue that is rotated into place (Rotational Flap) or with a free graft of tissue taken from under the upper eyelid (Autograft). The main goal is to see which method is better at preventing the pterygium from growing back over a 6-month period. A total of 342 patients with a primary pterygium will be randomly assigned to one of the two surgical groups.

Comparison Of Keratometric Readings Pre and Post Pterygium Excision With Conjunctival Autograft Transplantation

Pterygium, often called "surfer's eye," is a common eye condition in which a raised, fleshy growth of tissue extends from the white part of the eye onto the clear cornea. This growth can cause redness, irritation, blurred vision, and, in advanced cases, changes in the curvature of the cornea leading to distorted vision (astigmatism). The condition is more frequent in people exposed to sunlight, dust, and dry environments. The standard treatment for symptomatic pterygium is surgical removal. However, simple removal has a high chance of recurrence. To reduce this risk, surgeons commonly use a technique called conjunctival autograft transplantation, where a small piece of the patient's own conjunctiva is placed over the area after excision. This method not only lowers the recurrence rate but may also improve vision by reducing corneal irregularities. This study is designed to measure the changes in corneal curvature (keratometric readings) before and after pterygium excision with conjunctival autograft transplantation. By comparing preoperative and postoperative measurements, the study aims to determine how much this surgery improves corneal shape and reduces astigmatism. The hypothesis is that pterygium excision with conjunctival autograft transplantation will lead to a significant improvement in keratometric readings and reduce irregular astigmatism, thereby improving visual quality. This research will provide local evidence of the effectiveness of this procedure and help guide treatment strategies for patients suffering from pterygium-related visual problems.

A Clinical Trial on Safety and Efficacy of CBT-001 in Patients With Pterygium

The objective is to evaluate the safety and efficacy of low dose and high dose CBT-001 eye drop dosed twice daily for 24 months compared to vehicle in reducing conjunctival hyperemia and preventing pterygium progression in eyes with pterygia.

Clinical Outcomes of Sutured Versus Sutureless Conjunctival Autograft in Primary Pterygium Excision

The goal of this study is to find out if a certain technique in pterygium excision surgery ,using no sutures, is better than the technique mostly used ,which uses sutures. Investigators aim to find out whether the no sutures technique provides better efficiency and patient satisfaction than the traditional approach. They predict that if this study provides evidence of the advantages of this technique over the one used, surgeons would be encouraged to use it instead. Because not only would the patient benefit, the surgeon also may save operative time and effort used in the technique which uses sutures.

Comparison of Recurrence Between Mini-SLET and Limbal-Conjunctival Autograft Techniques in Primary Pterygium

The surgical treatment options for pterygium, an abnormal growth on the eye's frontal surface can be treated with several surgical techniques. The rates of pterygium coming back varies depending on the surgical technique employed and other factors related to the patient and surgery. The objective of this study is to assess the efficacy and safety of incorporating a single amniotic membrane with stem cells in the treatment of primary pterygium, aiming to enhance surgical outcomes and minimize recurrence rates.