Clinical trials

This study aims to conduct a randomized controlled clinical trial to compare the efficacy of a new type of massage device - eyelid support plate and glass rod assisted eyelid massage in improving MGD related dry eye symptoms, and evaluate the comfort and efficiency of both treatments, providing evidence-based support for clinical work

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.

The Proactive Ophthalmic Examination Cohort of Older Adults is a prospective cohort study recruiting community-dwelling older adults aged 65 years or older. Through comprehensive assessment of demographic profiles, medical histories, and ocular structural and functional parameters, alongside systematic collection of ophthalmic and systemic clinical data and biological specimens, we will establish a multidimensional, high-quality ocular health database encompassing demographic characteristics, socioeconomic factors, lifestyle variables, ocular disease risk factors, subjective ocular symptoms, objective examination findings, and biospecimens. The study will investigate the onset and progression patterns of ocular diseases, associated risk factors, and mechanisms of ocular aging in older populations, while simultaneously providing normal-controlled clinical and genomic data for other clinical studies on eye diseases. Furthermore, leveraging algorithmic innovation and artificial intelligence technologies, we will develop a personalized risk prediction and monitoring platform for age-related eye diseases, enhancing early screening and diagnostic capabilities and advancing precision medicine for ocular health in older adults.

Diabetic macular edema (DME) is a common cause of central visual loss in diabetic patients and a global public health burden around the world. Most patients with DME and vision loss require pharmacological inhibition using anti-VEGF agents with multiple monitoring visits that require both visual acuity testing and optical coherence tomography (OCT) to determine if re-treatment is warranted as well as the recommended time interval to the next follow-up visit. However, this treatment regimen often requires monthly or every other month clinic visits, which places a substantial burden on ophthalmic clinics and patients. Recently, portable self-administered Home OCT devices have been developed that allow for home-based OCT scanning of retinal diseases, e.g., DME, although these devices do not include visual acuity determination. The investigators previously proposed to deliver Home OCT devices and Home visual acuity tester to patients\' homes to complete routine monitoring visits at home. However, there is a lack of evidence regarding the safety and efficacy of this novel monitoring regimen for DME patients, specifically whether its use could reduce the burden associated with frequent hospital visits without sacrificing visual acuity outcomes. This study aims to provide evidence to support use of a novel monitoring regimen for DME patients that could substantially reduce the burden associated with frequent hospital visits without sacrificing visual acuity outcomes.

The goal of this observational study is to evaluate the location of phacoemulsification tip measured by intraoperative OCT during cataract surgeries and its impact on early postoperative changes of cornea and visual acuity. The main question it aims to answer is: In patients with age-related cataracts undergoing phacoemulsification, does the location (supracapsular, iris-lens diaphragm, or endocapsular) of the phaco tip affect postoperative corneal changes and visual acuity at early postoperative stage? Eyes having phacoemulsification for cataracts will receive intraoperative OCT imaging to evaluate the location of the phaco tip during surgery, and corneal changes and visual acuity will be measured postoperatively.

This randomized, parallel-group, assessor-blinded educational study will evaluate whether one session of AI-assisted structured guidance improves the quality of narrative literature reviews written by medical postgraduate students. A total of 102 students enrolled in an academic writing course will be randomly assigned to either an AI-assisted structured guidance group or a free AI use group. Both groups may use AI tools under academic integrity requirements and will complete a narrative literature review according to the same course requirements. The guidance group will receive one structured guidance session approximately two weeks before final submission. The session will be based on the six dimensions of the Scale for the Assessment of Narrative Review Articles (SANRA). The primary outcome is the final SANRA total score of the submitted narrative literature review.

Glaucoma is a group of irreversible, progressive optic neuropathies that can lead to severe visual field defects and even blindness, affecting nearly 95 million people worldwide. Based on anterior chamber angle structure, glaucoma is classified into primary angle-closure glaucoma (PACG) and primary open-angle glaucoma (POAG). Although POAG is more common, PACG is more severe and more likely to cause blindness if not managed appropriately. Globally, PACG accounts for approximately 25% of all glaucoma cases but is responsible for roughly 50% of glaucoma-related blindness. Generally, the term "glaucoma" implies optic nerve damage; however, glaucomatous optic neuropathy may be absent in subacute and acute angle-closure glaucoma. Therefore, according to international consensus, primary angle-closure disease is categorized as PACD-encompassing primary angle-closure suspect (PACS), primary angle closure (PAC), and PACG-based on the extent of angle closure, intraocular pressure elevation, and optic nerve damage. With advances in ophthalmic imaging, an increasing array of diagnostic modalities has been applied to glaucoma diagnosis. Optical coherence tomography (OCT), which utilizes low-coherence light to display cross-sectional images of the retina in vivo, represents a rapid, non-invasive, and continuously evolving imaging method. Building upon OCT, OCTA has emerged as a novel imaging technique that allows non-invasive visualization and assessment of blood flow in individual retinal layers \[5\]. Existing OCT and OCTA research on glaucoma primarily focuses on the optic disc and macula of glaucoma patients, providing evidence of changes in the retinal nerve fiber layer, macular ganglion cell thickness, optic nerve head structure, and peripapillary and macular vasculature. Other studies have examined choroidal vascular architecture and thickness in glaucoma; previous findings from our research group also indicate that choroidal vascular density is significantly lower in eyes with POAG and PACG compared to normal eyes, while choroidal stromal area is significantly greater in PACG than in POAG eyes and normal controls. Further investigation into choroidal and retinal alterations in glaucoma is warranted. Consequently, the OCT and OCTA fundus characteristics of patients with PACD and POAG remain an area with unexplored unknowns. This study utilizes OCT and OCTA to observe the choroidal and retinal tissue structure and vascular hemodynamics in patients with PACD and POAG, aiming to comprehensively investigate structural changes in the glaucomatous fundus, broaden new research directions, and explore and supplement the understanding of glaucoma pathogenesis.

This study uses a prospective, up-and-down sequential allocation method to determine the median effective dose (ED50) and 95% effective dose (ED95) of alfentanil combined with propofol for successful laryngeal mask airway (LMA) insertion in children aged 7-12 undergoing elective day surgery.

This is a multi-centre, open-label, parallel-group randomized controlled trial with the following objectives: Firstly, the investigators aim to evaluate the efficacy of web-based visual and perceptual training therapy on visual function in children with postoperative congenital ectopia lentis. Secondly, the investigators target to investigate the in stereoacuity, quality of life scores, and treatment compliance following visual and perceptual training intervention. Thirdly, to explore the safety profile of visual and perceptual training therapy software in this specific patient population. Lastly, this study aims to provide evidence-based recommendations for visual rehabilitation training strategies in children with postoperative congenital ectopia lentis in the Chinese population.

The pathogenesis of keratoconus remains unclear, and its natural course has yet to be fully understood. For non-progressive patients and post-surgical cases, clinical management primarily involves follow-up observation, with significant challenges in visual rehabilitation. This study aims to establish a prospective keratoconus cohort to identify risk factors, natural progression, and the efficacy of interventions. Additionally, it seeks to explore changes in ocular biometric parameters and other pathophysiological characteristics in keratoconus patients, investigate the relationship between keratoconus and systemic diseases or comorbidities, and assess refractive interventions and visual rehabilitation strategies for keratoconus patients.

This is a self-controlled randomized clinical trial to investigate the effect of capsular tension ring (CTR) implantation on intraocular lens (IOL) position in cataract patients with retinitis pigmentosa(RP). Each patient will receive CTR implantation in one eye, with the fellow eye serving as control. Postoperative outcomes, including visual acuity, IOL position, and postoperative complications will be compared between eyes.

This project proposes to conduct a prospective, multicenter registry study in rural China to evaluate, under real-world conditions, the implementation effectiveness of an integrated child eye health service model centered at the county level and coordinated across county, township, village, and school tiers. The target population will include all children and adolescents within participating counties, and the primary exposure will be the annual coverage and implementation intensity of this service model. The study will focus on its impact on clinical outcomes such as refractive error correction rates and referral rates following eye disease screening, while also examining annual trends in disparities in access to different eye care services. Through long-term and systematic observation, the project aims to clarify the sustained effects of this eye health service model on improving the management of pediatric eye diseases, enhancing visual function, and promoting health equity, thereby providing evidence-based support for optimizing the rural child eye care system in China.

This project proposes to establish a prospective, multicenter, randomized, controlled clinical study to compare the safety and efficacy of Intralesional Rituximab Injection versus Involved Site Radiation Therapy for the treatment of primary ocular adnexal MALT lymphoma. The aim is to provide high-level clinical evidence for the treatment of ocular adnexal MALT lymphoma and to offer patients treatment options that have fewer complications and comparable therapeutic effects.

To evaluate the preliminary safety of monocular and single subretinal injection of ZVS106e injection in the treatment of patients with hereditary retinal degeneration (ABCA4-IRDS) caused by ABCA4 biallelic mutations.

The goal of this observational study is to learn about the 6-month effects of Levator Resection combined with Fascial Sheath Suspension surgery in patients who undergo this procedure to treat congenital ptosis. The main questions it aims to answer are: Does this combined surgery improve best-corrected visual acuity, stereopsis, and other visual function indicators in patients with congenital ptosis within 6 months after the operation? Does this surgery lead to an improvement in patient-reported quality of life during the same period? Patients already scheduled to undergo this combined surgery as part of their regular medical care for congenital ptosis will complete a series of standardized ophthalmological examinations and a quality of life questionnaire before surgery and at 1, 3, and 6 months post-operation.

The goal of this clinical trial is to compare the effect of behavioral intervention (Baduanjin alone or laughter exercise plus artificial tears) versus artificial tears in patients with dry eye disease. The main questions it aims to answer are: * Does the Baduanjin improve the Ocular Surface Disease Index score of patients with dry eye disease? * Does the laughter exercise plus artificial tears improve the Ocular Surface Disease Index score of patients with dry eye disease? Researchers will compare behavioral intervention (Baduanjin alone or laughter exercise plus artificial tears) versus artificial tears to see if behavioral intervention works to treat dry eye disease. Participants will： * Do the Baduanjin 5 times per week, or do laughter exercise plus artifical tears 4 times per day, or use artificial tears alone 4 times per day for 12 weeks * Visit the clinic once right before the intervention and the 4, 8, 12, 16, 24, 36, and 48 weeks after starting the intervention for checkups and tests * Use the app developed by our study to record the behavioral intervention and/or use of eye drops.

The goal of this clinical trial is to evaluate the effect of intraoperative kappa-angle compensation on postoperative visual quality in patients undergoing small incision lenticule extraction (SMILE) using the VisuMax 800 platform. The study will enroll patients with myopia and a kappa-angle offset \< 0.2 mm. The main questions it aims to answer are: Does intraoperative kappa-angle compensation reduce postoperative higher-order aberrations after SMILE? Does kappa-angle compensation improve postoperative visual quality and refractive outcomes compared with no compensation? Researchers will compare SMILE with intraoperative kappa-angle compensation to SMILE without compensation to determine whether compensation leads to better optical quality and visual performance. Participants will: Undergo SMILE surgery with or without intraoperative kappa-angle compensation Complete scheduled postoperative examinations at 1 week, 1 month, 3 months, and 6 months after surgery Receive measurements of visual acuity, refraction, higher-order aberrations, contrast sensitivity, and safety outcomes

The goal of this clinical trial is to compare two intraoperative kappa-angle compensation strategies during small incision lenticule extraction (SMILE) using the VisuMax 800 platform in patients with relatively large kappa-angle offsets. Angle kappa represents the difference between the visual axis and the pupil center. In patients with a large offset, pupil-centered treatment may lead to decentration of the optical zone, which can induce higher-order aberrations and affect postoperative visual quality. The VisuMax 800 system allows intraoperative adjustment of the treatment center based on the measured offset, making different compensation strategies possible. The main questions this study aims to answer are: Does low kappa-angle compensation (50%) result in lower postoperative higher-order aberrations than high compensation (100%)? Does the compensation strategy influence visual acuity, refractive outcomes, contrast sensitivity, and subjective visual quality after SMILE? Are the measurements obtained from different diagnostic devices consistent when evaluating kappa-related parameters? Researchers will compare SMILE with low compensation to SMILE with high compensation to determine which strategy provides better optical quality and visual performance. Participants will: Undergo SMILE surgery using either low or high kappa-angle compensation Complete scheduled postoperative examinations at 1 month, 3 months, and 6 months Receive measurements of visual acuity, refraction, higher-order aberrations, contrast sensitivity, and patient-reported visual outcomes Be monitored for safety outcomes and adverse events during follow-up

The goal of this clinical trial is to learn if laser blended vision (LBV) works better than traditional monovision LASIK to correct presbyopia in adults aged 40 to 55 years. Presbyopia is an age-related condition that makes it hard to see things up close. The study will also evaluate the safety of both procedures. The main questions it aims to answer are: Does LBV improve distance, intermediate, and near vision at the same time after surgery? Is LBV as safe as traditional monovision LASIK? Researchers will compare laser blended vision to traditional monovision LASIK to see if LBV provides better overall vision after surgery. Participants will: Be randomly assigned to receive either laser blended vision or traditional monovision LASIK Have standard eye examinations before surgery Undergo LASIK surgery using the assigned method Return for follow-up visits at 1 week, 1 month, 3 months, and 6 months after surgery Complete vision tests and questionnaires about visual quality and satisfaction

The goal of this clinical trial is to learn if Anrikefon works as well as nalbuphine to control postoperative pain in adults undergoing ophthalmic surgery under general anesthesia. It will also learn about the safety and recovery outcomes of using Anrikefon. The main questions it aims to answer are: * Does Anrikefon provide pain relief that is not inferior to nalbuphine after ophthalmic surgery? * Does Anrikefon cause fewer central side effects, such as sedation or dizziness, compared with nalbuphine? * Does Anrikefon help patients recover and get discharged faster after day-surgery procedures? Researchers will compare Anrikefon to nalbuphine to see if Anrikefon can offer effective and safer perioperative analgesia for ophthalmic day-surgery patients. Participants will: * Receive either an intravenous dose of Anrikefon or nalbuphine during surgery. * Be monitored for pain scores, side effects, and recovery parameters after surgery. * Complete follow-up assessments.

The burden of myopia among Chinese children and adolescents is severe and trending toward younger ages, making control of myopia progression a public health priority. Current mainstream strategies include optical interventions, pharmacologic therapy, and environmental measures. Among these strategies, spectacle designs based on optical defocus-such as defocus-incorporated multiple-segment (DIMS) lenses-have demonstrated efficacy; however, the effect of such designs may attenuate over time because of "defocus adaptation." To address this limitation, D.D.C dual-control spectacles employ a densely staggered microlens layout, a gradient-defocus architecture, and an added peripheral "fogging zone" to disrupt the spatial distribution of defocus cues and reduce contrast, thereby delaying adaptation and enhancing myopia-control efficacy. The present study therefore proposes a 24-month prospective randomized controlled trial in Guangzhou, enrolling eligible myopic adolescents. The trial will first compare 12-month outcomes between D.D.C-A lenses and single-vision lenses, followed by a crossover and alternating-wear phase, to systematically evaluate the safety and efficacy of the D.D.C technology in slowing myopia progression.

This is a single-blind, single-center, parallel-group randomized controlled trial with the following objectives: First, researchers aim to compare the clinical efficacy of 2mm and 2.5mm post-limbal needle insertion in YAMANE technique for patients with congenital ectopia lentis. Second, the goal is to investigate the mean absolute refractive prediction error, IOL tilt and decentration, uncorrected visual acuity (UCVA), best-corrected visual acuity (BCVA), and corneal endothelial cell count at 3 months postoperatively. Third, it intends to explore the incidence of postoperative complications of the two needle insertion positions in this specific surgical method. Finally, this study aims to provide evidence for ophthalmic clinical practice, explore the optimal needle insertion point, and offer more precise and safe surgical plans for patients requiring sutureless transscleral IOL fixation.

Cataracts are the leading cause of blindness worldwide, and phacoemulsification combined with intraocular lens implantation has become the most mainstream surgical approach. With advancements in surgical techniques and equipment, this procedure has evolved from a simple vision-restoring surgery into the era of refractive surgery. Patients now have higher expectations for postoperative visual quality, particularly the recovery of early vision, which directly impacts their satisfaction. Intraoperative surgical details have a direct influence on postoperative visual acuity. Thanks to intraoperative optical coherence tomography (iOCT) technology, surgeons have gradually recognized that factors such as surgical incisions and intraoperative anterior chamber collapse can affect the survival of corneal endothelial cells after surgery, which is directly related to early postoperative vision and patient satisfaction. Swept-source intraoperative OCT (SS-iOCT) has further improved imaging range and clarity, helping us discover that the depth of intraoperative ultrasound energy use (such as cumulative dissipated energy) correlates with postoperative corneal endothelial cell loss. This suggests that compared to performing phacoemulsification at the capsular opening plane or in the anterior chamber, intracapsular phacoemulsification may reduce postoperative corneal endothelial cell loss, potentially leading to better early postoperative vision, which is crucial for patient satisfaction. However, evidence is still lacking. Therefore, this study aims to compare the effects of intracapsular versus extracapsular phacoemulsification on early postoperative vision, as well as long-term visual acuity, corneal endothelial cells, corneal changes, and the incidence of intraoperative and postoperative complications.

The macula is a pigmented area at the center of the retina, and responsible for the central, high-resolution color vision. Age-related macular degeneration (AMD) is a disease of the macula and is the leading cause of irreversible vision impairment and blindness worldwide. The yellow pigment at the macula is referred to as macular pigment. There is now strong evidence showing that macular pigment (MP), which is composed of the dietary carotenoids lutein (L), meso-zeaxanthin (MZ), and zeaxanthin (Z) is protective against AMD and vision loss. MP is a powerful antioxidant and also filters short-wavelength (blue) light at the macula. The AREDS2 study concluded that supplementation of L and Z is beneficial for patients with non-advanced age-related macular degeneration (AMD). The CREST and other studies had reported that dietary supplementation of these carotenoids could enhance contrast sensitivity among the Caucasian population, whereas little information is known about the effect of dietary supplementation of carotenoids on contrast sensitivity among Chinese. Thus in this study, we aim to investigate whether supplementation of a formulation containing 10 mg L, 10 mg MZ, and 2mg Z on contrast sensitivity in Chinese subjects free of retinal disease. This study is a single-center, double-blinded, placebo-controlled, randomized clinical trial conducted at Zhongshan Ophthalmic Center (ZOC), Sun Yat-sen University, Guangzhou, China. Participants in the intervention group received oral supplementation of 10 mg L, 10 mg MZ, and 2mg Z in a formula base oil suspension as one soft gel capsule in the morning per day. Participants in the control group receive one soft gel capsule of placebo oil per day. The intervention and placebo supplements are identical in external appearance, and the two treatments are therefore indistinguishable from each other. The duration of the study intervention is 12 months, and study visits are conducted at baseline, 3 months, 6 months, and 12 months. The primary outcome measure is the change in contrast sensitivity (CS) at 6 cycles per degree (cpd) over the study course: Y=CS4-CS1, where CS1 is CS at 6 cpd at baseline, CS4 is the CS at 6cpd at the 12-month follow-up. The secondary outcomes of this study include CS at other cpds and at other study visits, best-corrected visual acuity, subjective visual function, and skin carotenoid levels at each study visit.

This is a single-blind, single-center, parallel-group randomized controlled trial with the following objectives: First, researchers aim to compare the clinical efficacy of 2mm and 2.5mm post-limbal needle insertion in sutureless transscleral IOL fixation for patients with congenital ectopia lentis. Second, the goal is to investigate the mean absolute refractive prediction error, IOL tilt and decentration, uncorrected visual acuity (UCVA), best-corrected visual acuity (BCVA), and corneal endothelial cell count at 3 months postoperatively. Third, it intends to explore the incidence of postoperative complications of the two needle insertion positions in this specific surgical method. Finally, this study aims to provide evidence for ophthalmic clinical practice, explore the optimal needle insertion point, and offer more precise and safe surgical plans for patients requiring sutureless transscleral IOL fixation.