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Ocular Motility Disorders clinical trials

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NCT ID: NCT05948046 Recruiting - Myopia Clinical Trials

The Health-Related Quality of Life of the Patients With Symptomatic Convergence Insufficiency

Start date: June 1, 2022
Phase:
Study type: Observational

This trial is an observational cohort study. Patients aged 8-15 years with symptomatic convergence insufficiency and 150 patients with symptomatic convergence insufficiency who had not received visual training were selected from the Tianjin Eye Hospital Optometry Center and received 1 course of visual training treatment. Self-assessment and other assessments were combined, and the patient and guardian questionnaires were collected. The EQ-5D-Y and CHU9D scales were used to evaluate Chinese patients' health-related quality of life with symptomatic convergence insufficiency. The feasibility of the EQ-5D-Y and CHU9D scales in assessing the health-related quality of life of Chinese patients with symptomatic convergence insufficiency was analyzed. To assess the effectiveness of visual training on visual symptoms and improvement of quality of life in patients with symptomatic convergence insufficiency

NCT ID: NCT05877560 Recruiting - Clinical trials for Convergence Insufficiency

Non-invasive Brain Stimulation for Treating Symptomatic Convergence Insufficiency

NIBSCI
Start date: November 1, 2023
Phase: N/A
Study type: Interventional

The goal of this randomized controlled trial is to test the effectiveness of non-invasive brain stimulation in treating adults with symptomatic convergence insufficiency compared to vergence/accommodative therapy. The main questions it aims to answer are: 1. Can non-invasive brain stimulation shorten the treatment time of office-based vergence/accommodative therapy for convergence insufficiency? 2. Is non-invasive brain stimulation alone just as effective as office-based vergence/accommodative therapy in treating convergence insufficiency? The investigators hypothesize that non-invasive brain stimulation will shorten the treatment time from 12 weeks to 8 weeks of office-based vergence/accommodative therapy and that non-invasive brain stimulation alone would be equally effective as office-based vergence/accommodative therapy in improving symptomatic convergence insufficiency. Participants will be randomized into one of three treatment groups: 1. Non-invasive brain stimulation with office-based vergence/accommodative therapy. 2. Sham stimulation with office-based vergence/accommodative therapy. 3. Non-invasive brain stimulation only. Researchers will compare baseline measurements of near point of convergence (NPC) and positive fusional vergence (PFV) to post-treatment measurements for each group.

NCT ID: NCT05761106 Recruiting - Clinical trials for Temporomandibular Disorder

Effect of Exercises on Convergence Insufficiency in Individuals With Temporomandibular Disorders

Start date: February 1, 2023
Phase: N/A
Study type: Interventional

Temporomandibular Disorder is a disorder that involves the muscles of mastication, the temporomandibular joint (TMJ), and associated structures. Convergence insufficiency (CI) is characterized by the inability of the eyes to perform the eye adduction movement together, to focus on a nearby object. Studies show that there is a relationship between the presence of TMD and its signs and symptoms in patients with convergence insufficiency. Given this, the research question of this clinical trial is whether the effect of oculomotor therapy would be effective in improving the signs and symptoms of Temporomandibular Disorder. The design of this research is a Clinical Trial, Randomized and Blind. It will be divided into two moments: evaluation and intervention. The evaluations will be carried out using the Diagnostic Criteria for Temporomandibular Disorders: Fonseca Anamnestic Index (IAF), Clinical Protocol and Assessment Instruments (DC/TMD), Mandibular function Impairment Questionnaire (MFIQ), Numerical Pain Scale (END), Convergence Test, Meersseman Test and Convergence insufficiency symptom Survey (CISS). Individuals will be randomized into 2 groups: Group A (Treatment for Temporomandibular Disorder) and Group B (Treatment Oculomotor plus Treatment for Temporomandibular Disorder). Both groups will receive physiotherapeutic treatment for 12 weeks. Patients will be reassessed shortly after treatment, 3 and 6 months later. For data analysis, the statistical significance considered will be p<0.05.

NCT ID: NCT05603962 Recruiting - Clinical trials for Convergence Insufficiency

The Effectiveness of Visual Training in Convergence Insufficiency Patients

Start date: March 6, 2023
Phase: N/A
Study type: Interventional

Convergence insufficiency (CI) is one of the most common binocular vision disorders. The prevalence of CI ranges from 3% to 6% in school-aged children. CI symptoms include visual fatigue, headache, blurred vision, and diplopia and could be caused while using near-distance viewing. These symptoms might become more severe with increasing need to perform near-distance tasks. Long-term visual symptoms could result in a negative impact on learning behaviors and work performance in patients. Nowadays, visual training is the main type of management for CI patients clinically; however, the existing training protocol required patients to make several visits to the clinic for visual training, which might increase the burden for patients and result in higher failures in training. Therefore, this study will use a simple training method by utilizing prisms for CI patients to train at home, then compare visual symptoms and binocular vision after the training. In stage I of this study, investigators will recruit 60 symptomatic CI participants aged 9 to 30 years old to do a 6-week visual training with the prisms (15 min/time, 3 times/week). The post-training outcomes will be collected at week 4 and week 6. In stage II, all of the participants will be randomly divided into the "stop training group" and the "continue training group." The participants in the "continue training group" will have the same 6-week prism training and in the "stop training group" will stop all the prism training during this period. The final post-training outcomes of all the participants will be collected again at week 12. In this study, investigators will investigate the effectiveness of the prisms training for 6 weeks and for 12 weeks on visual symptoms and binocular vision in CI patients, and evaluate whether the training effect will be affected by stopping training after 6 weeks.

NCT ID: NCT05522595 Not yet recruiting - Clinical trials for Binocular Vision Disorder

Performance and Safety Evaluation of the S360 Medical Device Software.

ArgoS360
Start date: November 2, 2023
Phase: N/A
Study type: Interventional

The aim of this interventional, cross-sectional study is to evaluate the performance and the safety of the medical device software S360. This clinical investigation is performed in order to demonstrate the conformity of the medical device, when operating under the normal conditions of its intended use, in accordance with the General Safety and Performance Requirements pertaining to clinical evaluation of the device regarding the Medical Device Regulation (MDR) 2017/745 (EU).

NCT ID: NCT05338450 Recruiting - Multiple Sclerosis Clinical Trials

Clemastine Fumarate as Remyelinating Treatment in Internuclear Ophthalmoparesis and Multiple Sclerosis

RESTORE
Start date: August 30, 2022
Phase: Phase 3
Study type: Interventional

Rationale: Clemastine fumarate has been identified as potential remyelinating therapy for multiple sclerosis (MS). The (long-term) effects of clemastine need to be confirmed in clinical models for MS. Internuclear ophthalmoparesis (INO) may be used as a clinical model for investigating remyelinating therapies by measuring horizontal eye movements with infrared oculography. Furthermore, infrared oculography combined with a single dose of fampridine may be used to identify individuals with MS that are most likely to benefit from remyelinating therapy. Objective: To assess the (long-term) efficacy of clemastine fumarate in improving dysconjugacy of eye movements in patients with internuclear ophthalmoparesis and multiple sclerosis. Secondly, to assess whether a response to a single dose of fampridine can predict the effects of clemastine treatment. Study design: A single-centre double-blind randomized placebo-controlled trial consisting of a 6 months (180 days) treatment period followed by a 30 months follow-up period. Study population: 80 MS patients, age 18-70 years, with INO. Intervention: The intervention group will receive 4 mg of clemastine fumarate twice daily (8 mg/day) for 6 months (180 days), the control group will receive an equivalent amount of placebo. At baseline all participants will receive a single 10 mg dose of fampridine. Main study parameters/endpoints: The primary outcome measure is the change in versional dysconjugacy index (VDI) of area under the curve (AUC) measured by infrared oculography. Secondary outcome measures include changes in other VDI measures (peak velocity per amplitude (PV/Am) and peak velocity (PV)), changes in VDI after single fampridine dose, other oculography parameters (e.g. saccadic latency, anti-saccades), (peripheral) retinal nerve fibre layer (pRNFL) and (macular) ganglion cell inner plexiform layer (mGCIPL) thickness measured by OCT, SDMT, EDSS, high and low contrast visual acuity, subjective visual functioning (NEI-VFQ-25 and NOV-AU questionnaire), quality of life (EQ5D-5L) and fatigue (CIS20R and NFI-MS questionnaire). Nature and extent of the burden and risks: Participation in the study will consist of a total of 7 study visits. Study visits will include physical/neurological examination, infrared oculography, OCT, visual acuity tests, a cognition test (SDMT), 5 questionnaires and blood samples for safety laboratory tests. Considering both clemastine and fampridine are registered and well-established drugs and have been used in clinical practice, the estimated risk of unexpected adverse reactions is low.

NCT ID: NCT05311917 Recruiting - Clinical trials for Convergence Insufficiency

Home Vision Therapy and Prism Prescription in Presbyopic Persons With Convergence Insufficiency

Start date: April 3, 2022
Phase: N/A
Study type: Interventional

convergence insufficiency is one of the most common binocular vision problems in which the eyes tend to have more exophoria in near than distance activities. Its prevalence is typically reported from 2.25% to 29.6% depending on the study population and its definition. Most of its symptoms include difficulty seeing at close works, headache, eye pain during study, blurred vision, diplopia, movement of words in reading, a feeling of pressure in the eye, and lack of concentration. Its signs include increasing near point of convergence, more exophoria at near than distance, decreased AC / A ratio, decreased positive fusional vergence. In patients with convergent insufficiency, the first valid and standard questionnaire to assess the frequency and type of symptoms used before and after convergence insufficiency treatment is the convergence insufficiency symptom survey (CISS) questionnaire. Generally, vision therapy is the first choice for convergence insufficiency management and the other choice is base in prism prescription. On the other hand, due to the changes in the interaction of the accommodation and convergence systems with increasing age, It is necessary to study how these systems interact and compare their responses to the active treatment of vision therapy and inactive prescription of base in prism. In this controlled study, investigators will evaluate and compare the effect of vision therapy and base in prism prescription in patients over 40 years of age. this investigation will help to clarify which treatment is more effective. This study will have two phases. In the first phase, investigators will seek to check the reliability and validity of the Persian version of CISS questionnaire for the elderly patients. For this purpose, investigators will use the Persian version questionnaire in previous study that assessed for young adults, and the investigators will modify it and check the reliability and validity of the final Persian version for subjects with presbyopia. This modified CISS questionnaire will be investigated in the elderly participants and the appropriate cut off point to differentiate between the normal group and the group with convergence insufficiency will be determined. in the second phase one optometrist (Z.K.R) will do the preliminary examination and another optometrist (S.A) will do the interventions. After the initial examination and having the inclusion criteria, patients will be invited to participate in the study, the nature of the research will be explained to subjects and informed consent will be obtained from them. Before randomization, patients are asked to complete the CISS questionnaire and submit this questionnaire to Optometrist No. 1 (Z.K.R).According to the randomization all patients will be assigned to one of the treatment or control groups by optometrist No. 1. Vision therapy exercises, necessary trainings and prescriptions are given to all patients by Optometrist No. 2 (S.A).For the participants in the control group only near glasses will be prescribed as a conventional treatment, for the second group near glasses with base in prism according to sheard's criterion will be prescribed and in the third group, the prescription of near glasses will be given along with the complete training of the home exercises.

NCT ID: NCT05262361 Recruiting - Clinical trials for Mild Traumatic Brain Injury

Persistent Post-Concussion Symptoms With Convergence Insufficiency

PPCS-CI
Start date: September 1, 2021
Phase: N/A
Study type: Interventional

Our successful R01 discovered 1) the neural mechanistic difference between typically occurring convergence insufficiency (TYP-CI) and binocularly normal controls and 2) the underlying mechanism of office-based vergence and accommodative therapy (OBVAT) that is effective in remediating symptoms. Adolescent and young adult concussion is considered a substantial health problem in the United States where our team has shown that about half of patients with persistent post-concussion symptoms have convergence insufficiency (PPCS-CI), causing significant negative impact associated with reading or digital screen-related activities, and is believed to be one factor causing delayed recovery impacting return to school, sports, or work. The results of this randomized clinical trial will impact the lives of adolescents and young adults with PPCS-CI to guide professionals on how to manage and treat those with PPCS-CI by 1) comparing the differences between PPCS-CI and TYP-CI, 2) discovering the neural mechanism of OBVAT for PPCS-CI compared to standard-community concussion care, and 3) determining the effectiveness of 12 one-hour sessions compared to 16 one-hour sessions of OBVAT.

NCT ID: NCT05087563 Terminated - Clinical trials for Convergence Insufficiency

Neurolens Convergence Insufficiency Study

Start date: November 22, 2021
Phase: N/A
Study type: Interventional

To understand the benefits of the neurolens Measurement Device and neurolens treatment as it pertains to treating symptoms related to Convergence Insufficiency. It is a Prospective randomized double masked two arm performed on a minimum of 100 to a maximum of 150 subjects identified as symptomatic (CISS questionnaire score equal to or greater than 16) done across 3-10 clinical sites. There are two subgroups: a minimum of 50 in each subgroup(subgroup 1: pre-presbyopic (18-40 years); subgroup 2: presbyopic subjects(41-60 years).

NCT ID: NCT05070767 Completed - Headache Clinical Trials

Neurolens Headache Study

Start date: October 18, 2021
Phase: N/A
Study type: Interventional

To understand the benefits of the neurolens Measurement Device and neurolens treatment as it pertains to treating symptoms related to Chronic Headaches. It is a Prospective randomized double masked two arm performed on a minimum of 200 to a maximum of 300 subjects identified as symptomatic (HIT-6 questionnaire score equal to or greater than 56) done across 3-15 clinical sites. There are two subgroups: a minimum of 100 in each subgroup (subgroup 1: pre-presbyopic (18-40 years); subgroup 2: presbyopic subjects (41-60 years).