Cranial Nerve Palsy

Researchers are evaluating outcomes of facial reanimation surgeries in patients with extensive, permanent, unilateral mid-facial paralysis from various causes. The study aims to compare facial disability and patient perceptions of facial appearance, well-being, and satisfaction among four groups undergoing different types of free gracilis muscle transfer surgeries. The investigation also compares surgeons' assessments with objective 3D analyses to determine the usefulness of 3D measures as outcome tools. This prospective observational study includes patients aged 18 to 75 scheduled for facial muscle reconstruction with one of four nerve innervation methods: trigeminal nerve graft, cross-face nerve graft, dual innervation, or midfacial modification involving nerve coaptation and selective neurolysis. Participants will be recruited from a single treatment center and followed at three visits: before surgery, and at 5 and 18 months after surgery to track changes in facial movement and patient well-being. At each visit, patients complete psychosocial questionnaires assessing the impact of paralysis and recovery, undergo 3D dynamic facial movement recordings, static 3D facial photography, and video recordings of facial animations. Data collected include facial impairment and disfigurement measures, patient-centered quality of life questionnaires, and comparisons of clinical scoring with 3D objective assessments. The total study duration for each participant is 18 months, focusing on long-term surgical outcomes.

Researchers are studying a new feedback-enabled magnetic device designed to temporarily manage blepharoptosis, a condition where the upper eyelid droops. The study aims to evaluate how well the device improves eyelid height, symmetry of blinks, and reduces symptoms like visual field obstruction, blurred vision, and discomfort on the eyelid and surrounding skin. The safety and effectiveness of this device will be compared with outcomes from patients who undergo surgery for the same condition. The device includes near-infrared sensors, a magnetic actuator, an iron sheet for attaching to the affected eyelid, and a biosignal module. During the study, participants will use the device for sessions lasting about 120 minutes each. Researchers will measure the distance the eyelid lifts and assess muscle activity related to eyelid movement. Both subjective sensations and any side effects will be monitored to evaluate the device’s performance. Participants will have their eyelid measurements taken before and after using the device, along with assessments of visual field changes and muscle activity. These evaluations occur shortly after device use and include checking for any skin irritation or discomfort. The study also includes follow-up examinations comparing device use with surgical treatment outcomes at one and six months. The total participation time for each device use session is about two hours, with longer-term follow-up for surgical cases.

Researchers are studying the safety and effectiveness of a single dose of nexiguran ziclumeran (NTLA-2001) compared to a placebo in people with hereditary transthyretin amyloidosis with polyneuropathy (ATTRv-PN). This phase 3, multinational, randomized, double-blind, placebo-controlled trial involves about 60 participants with this nerve disease and genetic condition affecting the peripheral nervous system. Participants will be randomly assigned to receive a single intravenous infusion of either nexiguran ziclumeran 55 mg or a placebo of normal saline. To give everyone a chance to receive the study drug, participants may switch to the other treatment group at either 12 or 18 months, depending on specific study criteria. The study is designed to compare the effects of the drug and placebo over time. During the study, participants will be monitored for nerve function using the Modified Neuropathy Impairment Score +7 (mNIS+7) over 18 months and blood levels of serum transthyretin at 29 days and 18 months. Quality of life, body mass index, and other health measures will also be evaluated. The study includes careful safety monitoring and will last up to 18 months with ongoing assessments to track participants' nerve health and overall well-being.

Researchers are investigating the feasibility of producing artificial vision in people who are blind by using a device called the Intracortical Visual Prosthesis (ICVP). This study aims to test the safety of the ICVP system and evaluate whether electrical stimulation of the brain's visual processing areas can create visual percepts. The study involves participants with no light perception or very limited vision who have been blind for at least one year and have a history of normal or near-normal vision in early life. The intervention involves implanting wireless floating microelectrode arrays (WFMAs) into the visual cortex on one side of the brain. These devices deliver wirelessly transmitted electrical stimulation intended to induce artificial vision. Each participant will have multiple WFMA devices implanted. After surgical recovery, participants will undergo weekly testing for one to three years to assess the ability of electrical stimulation to generate visual percepts and evaluate the device's safety and efficacy. Participants will attend regular testing sessions to measure visual perception responses to stimulation and monitor safety outcomes. Researchers will perform assessments from two weeks after surgery through the entire device use period, up to three years. The primary outcome is the safety of the WFMA-based cortical interface, while secondary measures evaluate its effectiveness at producing visual percepts. The study includes video and audio recordings, cognitive and spatial functioning tests, and MRI scans. Participant involvement may last up to three years, with ongoing monitoring throughout the study.

Researchers are studying transient diplopia, which is a brief episode of double vision, to understand its causes. This study focuses on distinguishing whether the diplopia is due to ischemic causes, which require urgent care, or other origins such as ophthalmological or non-ischemic neurological reasons. The goal is to develop a clinical score that helps doctors identify an ischemic cause quickly and accurately. Participants will undergo clinical, ophthalmological, and neurological evaluations. These include questionnaires about symptoms and vascular risk factors, brain imaging such as MRI and MRI angiography, heart monitoring with ECG and Holter, echocardiography, and various blood tests. Eye exams include visual field tests, optical coherence tomography, and retinography. The study observes adults who have experienced transient diplopia within the last 8 days. During the study, participants will be followed for 3 months to monitor the cause of their initial diplopia and any new ischemic events, including transient diplopia attacks, ischemic strokes, or transient ischemic attacks affecting vision or other functions. The main outcome is identifying whether the diplopia had an ischemic cause. Safety and ongoing health are monitored through these assessments over the follow-up period.

This observational study investigates the effects of Levator Resection combined with Fascial Sheath Suspension surgery on patients with congenital ptosis. It aims to evaluate whether this combined surgery improves best-corrected visual acuity, stereopsis, and other visual function measures within six months after the operation. The study also explores whether patients experience an improvement in quality of life during the same period. Patients scheduled for this combined surgery as part of their regular medical care will be followed prospectively. They will undergo standardized ophthalmological examinations and complete a quality of life questionnaire before surgery and again at 1, 3, and 6 months after the procedure. This design allows researchers to observe changes over time in both visual function and psychological wellbeing. Participants will be involved in evaluations that include vision tests and quality of life assessments at multiple time points spanning from before surgery to six months after. The primary outcome measured is stereoacuity, assessed from enrollment through the six-month post-surgery period. The study is led by the Zhongshan Ophthalmic Center at Sun Yat-sen University and includes patients aged 3 to 60 years with congenital ptosis.

Researchers are evaluating the efficacy and safety of a new drug called STN1013800 ophthalmic solution for treating acquired blepharoptosis in Chinese patients. This condition involves drooping of the upper eyelid, and currently, there are no approved medicines for this in China. This is a Phase III randomized, double-masked, placebo-controlled study designed to compare STN1013800 with a placebo solution. Participants will receive either 0.1% STN1013800 ophthalmic solution or a placebo once daily for 42 days, based on prior clinical trial results. The study includes a screening period lasting 3 to 7 days to confirm eligibility. The interventions involve applying the assigned eye drops daily, with the study treatment and placebo groups monitored in parallel. During the study, participants will undergo multiple assessments including margin reflex distance-1 (MRD-1) measurements and Leicester Peripheral Field Test (LPFT) scores at several time points (Day 1 Hour 6, Day 14 Hour 2, and Day 42). Researchers will track changes from baseline in eyelid position and visual function to evaluate treatment effects. Safety and adherence will also be monitored throughout the 42-day treatment period.

Researchers are evaluating a new handheld optical coherence tomography (OCT) device designed to automatically align with the eye to capture detailed retinal images. This pilot study aims to assess this advanced imaging technology in healthy adult volunteers, adult patients, and pediatric patients with eye and retinal diseases, addressing current challenges in imaging uncooperative patients, especially children. The study is observational and led by Duke University, focusing on improving imaging speed, alignment, and data quality for retinal assessment. The study uses a Swept Source OCT system with enhanced hand-held probe technology that auto-aligns to the patient’s eye and detects image quality in real time, automatically saving optimal images. Participants include 20 healthy adults, 20 adult patients, and 10 pediatric patients from ophthalmology clinics. Imaging will be performed during clinical visits, with up to four single imaging sessions over two years to capture detailed retinal structure and blood flow. Participants will undergo retinal imaging using the handheld OCT device during their clinical visits. Researchers will analyze images for retinal microanatomy abnormalities and retinal thickness at specific eye regions, collecting data securely for further analysis. The study will monitor outcomes over multiple sessions for up to two years, with no known risks reported from prior handheld OCT use. The total participation duration depends on the number of imaging sessions completed within the study timeframe.

Researchers are studying individual differences in eye movement patterns during active visual search, focusing on how attentional and inhibitory functions contribute to these variations. This research aims to better understand why some people fixate on a single location longer than others before moving their eyes, using behavioral tasks to measure these cognitive processes. Participants will complete three tasks while their eye movements are tracked. The first is a visual search task where they find a target among distractors. The second assesses attention by detecting briefly-presented peripheral targets. The third task evaluates inhibitory control by having participants attempt to stop programmed eye movements. Eye-tracking technology records behavioral performance and eye movements throughout. During the study, participants will perform these tasks seated with their heads stabilized. Researchers will measure fixation duration, fixation count, reaction times, attention thresholds, and responses to distractions. Data from these tasks will provide insights into eye movement variability, with no masking or placebo involved. The study runs from September 2024 to May 2026, enrolling healthy adults aged 18 to 65 years.

This research aims to compare two surgical techniques, anterior and posterior white line advancement, for correcting primary aponeurotic ptosis in adults. The study seeks to determine if the anterior approach improves eyelid position, measured by Marginal Reflex Distance 1 (MRD1), better at 6 months than the posterior approach. It also evaluates differences in eyelid symmetry, contour, vision, and patient satisfaction between the two methods. Participants will be randomly assigned to one of two groups: one receiving the anterior approach involving a skin crease incision to access and advance the levator aponeurosis, and the other receiving the posterior approach, which uses a conjunctival incision without a skin cut. Both surgeries involve advancing the white line to the anterior tarsus using sutures. The study includes follow-up visits at 7 days, 2 months, and 6 months after surgery. During these visits, researchers will measure eyelid position and symmetry, evaluate eyelid contour using both software and masked evaluators, and test vision and tear film stability. Patients will also complete surveys on dry eye symptoms, scar quality, satisfaction, and psychosocial function. Surgical time and complications will be monitored. All images and data will be securely stored, and outcome assessors will be blinded to the group assignments for certain evaluations.