Home-Based Therapy for Symptomatic Convergence Insufficiency in Children: A Randomized Clinical Trial. A Study of Clinical Characteristics, Treatments, and One-Year Outcomes of Adults with Strabismus Rochester, MN . Objective: This report describes the design and methodology of the Convergence Insufficiency Treatment Trial (CITT), the first large-scale, placebo-controlled, randomized clinical trial evaluating treatments for convergence insufficiency (CI) in children. Shaun original wrote a 2-part article here on the Risk and Recovery Process Following Concussions in Sports and The Role of Rehabilitation Following Concussions.In this new post, Shaun shares more thoughts on the treatment of concussions, specifically regarding convergence insufficiency. The Convergence Insufficiency Treatment Trial (CITT) Study Group. Convergence insufficiency (CI) is a common and distinct binocular vision disorder that affects approximately 4% of school age children and adults in the United States. Currently, many eye care professionals only offer home-based therapy, while others suggest passive treatment with base-in prism. Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number): Why Should I Register and Submit Results? We also report the clinical and demographic characteristics of patients. 2016 Dec;93(12):1457-1465. Study record managers: refer to the Data Element Definitions if submitting registration or results information. Objective: This report describes the design and methodology of the Convergence Insufficiency Treatment Trial (CITT), the first large-scale, placebo-controlled, randomized clinical trial evaluating treatments for convergence insufficiency (CI) in children.We also report the clinical and demographic characteristics of patients. CONVERGENCE INSUFFICIENCY TREATMENT STUDY (CITS) PROCEDURES MANUAL Version 5.0 March 4, 2014 . Vergence Eye Movements. This treatment sequence is a wellaccepted approach for treatment of convergence insufficiency and has been successfully implemented in previous randomized clinical trials … Talk with your doctor and family members or friends about deciding to join a study. N2 - Objective: This report describes the design and methodology of the Convergence Insufficiency Treatment Trial (CITT), the first large-scale, placebo-controlled, randomized clinical trial evaluating treatments for convergence insufficiency (CI) in children. Long-term effectiveness of treatments for sympto- A recently completed randomized clinical trial, the Convergence Insufficiency Treatment Trial (CITT), demonstrated that a 12-week program of office-based vergence/ accommodative therapy with home reinforcement was more effective than home-based near target pencil push-ups, home-based computer accommodative therapy plus pencil push-ups, or office-based placebo therapy in treating the … To evaluate the kinetics of change in symptoms and signs of convergence insufficiency (CI) during 12 weeks of treatment with commonly prescribed vision therapy/orthoptic treatment regimens. utes, similarly to that recommended by The Convergence Insufficiency Treatment Trial Group [16]. Cited by lists all citing articles based on Crossref citations.Articles with the Crossref icon will open in a new tab. Study Chair: CITT-ART: Convergence Insufficiency Reading and Attention Treatment Trial (CITT) NEI funded, May 2014 – April 2019; Co-Protocol Chair: Convergence Insufficiency Treatment Study (CITS) 2012-present; Study Chair: Convergence Insufficiency Treatment Trial (CITT) NEI sponsored, October 2004 – September 2008 Relocation outside of area of an active PEDIG site within the next 15 months is not anticipated. The purpose of this study is to describe clinical characteristics, treatments, and one-year outcomes for adults who have convergence insufficiency, divergence insufficiency… N2 - Objective: This report describes the design and methodology of the Convergence Insufficiency Treatment Trial (CITT), the first large-scale, placebo-controlled, randomized clinical trial evaluating treatments for convergence insufficiency (CI) in children. 2008; 15(1):24-36 (ISSN: 1744-5086). I read the article by Scheiman et al 1 entitled “A Randomized Clinical Trial of Treatments for Convergence Insufficiency in Children” in the January 2005 issue of the A RCHIVES with great interest. 28,29 In the trial that evaluated the effectiveness of base-in prism reading glasses prescribed according to Sheard's criterion (convergence … We also report the clinical and demographic characteristics of patients. Convergence insufficiency is often associated with symptoms such as frequent loss of place while reading, loss of concentration, having to re-read, reading slowly, poor comprehension, sleepiness, blurred vision, diplopia, headaches, and/or eyestrain. Subjects will perform the computer therapy while wearing red/blue glasses and accommodative therapy will be performed using the HTS accommodative flippers. [ 30, 35] Follow-up depends on the severity … At a Pediatric Eye Disease Investigator Group (PEDIG) meeting (Tampa, January 2009), the results of a poll of attendees indicated that a large majority of pediatric ophthalmologists continue to recommend home-based near target push-ups as the initial treatment approach for children with symptomatic CI in spite of the CITT results. Long-term effectiveness of treatments for sympto- Convergence Insufficiency Treatment Trial Study Group. Register to receive personalised research and resources by email, The Convergence Insufficiency Treatment Trial: Design, Methods, and Baseline Data, /doi/full/10.1080/09286580701772037?needAccess=true. About this study. Patient must be wearing appropriate refractive correction (spectacle or contact lenses) for at least 2 weeks prior to enrollment if refractive error is present (based on a cycloplegic refraction within the last 6 months) that meets the following: To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to the procedures manual for further details. Success is based on the mean PFV (positive fusional vergence) blur, defined as having a mean PFV blur of >15 pd at 6 weeks and a 6-week to baseline ratio of >1.419 for mean PFV blur. Arch Ophthalmol. Mitchell Scheiman, FCOVD, has completed the 12-week study, known as the Convergence Insufficiency Treatment Trial (CITT), found that approximately 75 percent of those who received in-office therapy by a trained therapist plus at-home treatment reported fewer and less severe symptoms related to reading and other near work after the office-based vision therapy. Main Outcome Measures: Convergence Insuffi-ciency Symptom Survey score after 12 weeks of treat-ment. The current study is a multi-center randomized clinical trial to evaluate the effectiveness of home-based computer vergence/accommodative therapy and home-based near target push-ups in children 9 to <18 years of age with symptomatic CI. Clinical success is defined according to whether both criteria (below) are met as follows: Improvement in all 3 outcome measures at 12 weeks will be defined as follows: (Note: All 3 criteria must be met in order to be classified as an "improver" at the 12-week primary outcome visit). Figure 2 outlines the treatment sequence. 1. Ophthalmic Epidemiol. We also report the clinical and demographic characteristics of patients. Please remove one or more studies before adding more. When the subject is no longer able to maintain a single image of the pencil, he/she will slowly move the target away from the nose until the pencil becomes single again. Optom Vis Sci. Active treatment: A multi-site randomized clinical trial funded by the National Eye Institute has proven that the best treatment for convergence insufficiency is supervised vision therapy in a clinical office with home reinforcement (15 minutes of prescribed vision exercises done in … View This Abstract Online; The convergence insufficiency treatment trial: design, methods, and baseline data. Today’s guest post on concussion treatment comes from Shaun Logan, DPT. Active treatment: A multi-site randomized clinical trial funded by the National Eye Institute called the Convergence Insufficiency Treatment Trial showed: The best treatment for CI is supervised vision therapy in a clinical office with home reinforcement (15 minutes of prescribed vision exercises done in the home five days per week). Many clinicians believe that the less costly and less complex treatment option should be attempted first. A complete pediatric eye exam with cycloplegic dilation i… protocols (some studies measure near point of convergence with a pencil, whereas others use an accommodative target that may alter measurements). Main Outcome Measures: Convergence Insuffi-ciency Symptom Survey score after 12 weeks of treat-ment. Due to sample size considerations, it was not feasible to compare the HB-PU group with the HB-P group as a primary outcome pairwise comparison based on the assumed successful outcome percentages of 15% vs. 10%. View This Abstract Online; The convergence insufficiency treatment trial: design, methods, and baseline data. Convergence Insufficiency Symptom Survey (CISS) Administration Convergence Insufficiency Symptom Survey (CISS) Description The CISS is a 15-item questionnaire designed to assess the severity of the subject’s convergence insufficiency (CI) symptoms. Convergence Insufficiency Treatment Trial Study Group. PFV is recorded as the prism magnitude where vision is first blurred (or break if no blur is reported). Thus, the Convergence Insufficiency Treatment Trial - Attention & Reading Trial (CITT-ART) was designed as a prospective randomized trial to determine whether reading and attention improve in school- reinforcement (OBPT) as treatments for symptomatic convergence insufficiency (CI). The assumed success percentages were determined based on the Convergence Insufficiency Treatment Trial (CITT) 14 and clinical expertise. Methods: We prospectively randomized children 9 to 17 years of age to one of four treatment groups: 1) home-based pencil push-ups, 2) home-based computer vergence/accommodative therapy and pencil push-ups, 3) office-based vergence/accommodative therapy with home reinforcement, 4) office-based placebo therapy. 17 The results showed that office-based vergence/accommodative therapy was no more effective than office-based placebo therapy … The study had well-defined eligibility criteria, a standardized treatment protocol administered by trained therapists, and … 5 Howick Place | London | SW1P 1WG. We also report the clinical and demographic characteristics of patients. The task remains constant, but the nature of the procedure changes with time: Pairwise treatment group comparison (HB-C versus HB-PU) of the percentages of participants meeting success criteria using binomial regression adjusting for baseline covariates of CISS score (<28 points vs ≥ 28 points), mean NPC break (<10 cm vs ≥ 10 cm), and mean PFV blur (≥ 15 PD vs <15 PD) using linear contrasts with Bonferroni adjustment for multiple comparisons (Type I error rate = 2.5%). •Surgical Care: Eye muscle surgery should only be considered with a licensed eye care specialist’s recommendation (Cooper, 2001 -2005). In preparation for our randomized clinical trial, the Convergence Insufficiency Treatment Trial (CITT) Study Group completed 2 pilot studies that were placebo-controlled, randomized trials investigating the effectiveness of passive and active treatments for symptomatic CI in children. The Convergence Insufficiency Treatment Trial–Attention & Reading Trial Investigator Group Clinical Sites. Main Outcome Measures—Convergence Insufficiency Symptom Survey (CISS) score after 12 weeks of treatment. Subjects will be prescribed 5 minutes/day of placebo yoked prism flipper therapy for 5 days/week during the 12 week treatment phase.  (Clinical Trial), Triple (Participant, Care Provider, Outcomes Assessor), Effectiveness of Home-Based Therapy for Symptomatic Convergence Insufficiency, Active Comparator: Computer-based therapy (CBT), Active Comparator: Near target push-up (NTP), Cranberry TWP, Pennsylvania, United States, 16066, Philadelphia, Pennsylvania, United States, 19141. The Convergence Insufficiency Treatment Trial–Attention & Reading Trial (CITT-ART) was a multicenter, double-masked, randomized clinical trial designed to determine if office-based vergence/accommodative therapy resulted in improvements in reading 16 and attention in 9- to 14-year-old children with symptomatic convergence insufficiency. [3] A more recent trial completed by the Pediatric Eye Disease Investigator Group (PEDIG) evaluated the effectiveness of a home-based therapy and suggested that the home-based therapy alone had a less successful outcome compared to treatment that included in-office visits; however, recruitment was an i… The NTP group will be assigned placebo home-based computer vergence/accommodative therapy (5 minutes/day) plus near target push-ups (15 minutes/day) for a total of 20/minutes per day, 5 days per week for the 12-week treatment phase. People also read lists articles that other readers of this article have read. The baseline data reported herein define the clinical profile of those enrolled into the CITT. The number of subjects classified as a success based on clinical measures of CI (mean NPC break & mean PFV blur) at the 6-week visit. Mark Boas§, Rachel Coulter*, Kristine Hopkins¶, Susanna Tamkins**; The Convergence Insufficiency Treatment Trial Study Group ABSTRACT Purpose. We also report the clinical and demographic characteristics of patients. A recently completed randomized clinical trial, the Convergence Insufficiency Treatment Trial (CITT), demonstrated that a 12-week program of office-based vergence/ accommodative therapy with home reinforcement was more effective than home-based near target pencil push-ups, home-based computer accommodative therapy plus pencil push-ups, or office-based placebo therapy in treating the symptoms and signs associated with symptomatic CI in children 9 to 17 years of age. Success is based on the mean NPC (near point of convergence) break is defined as having a mean NPC break of <6 cm at 6 weeks and a 6-week to baseline ratio of <0.763 for mean NPC break. Identification of the most effective treatment regimen is important because of the high prevalence of this binocular vision disorder and its potential effect on reading and other near visual activities. Randot Preschool stereoacuity of at least 400 seconds of arc, No use of a plus add for near or base-in prism for at least 2 weeks preceding enrollment, Myopia more than -0.75D spherical equivalent (SE) in either eye, Hyperopia more than +2.00D SE in either eye. 2020 Dec 2;12:CD006768. N2 - Objective: This report describes the design and methodology of the Convergence Insufficiency Treatment Trial (CITT), the first large-scale, placebo-controlled, randomized clinical trial evaluating treatments for convergence insufficiency (CI) in children. Parent has home phone (or access to phone) and is willing to be contacted by Jaeb Center staff. Thus, the Convergence Insufficiency Treatment Trial - Attention & Reading Trial (CITT-ART) was designed as a prospective randomized trial to determine whether reading and attention improve in school-aged children with symptomatic CI who are treated with OBVAT. Oct 2008;126(10):1336-1349. [2] At that time the group used the acronym CIRS (Convergence Insufficiency Reading Study). At enrollment, subjects will be prescribed 15 minutes/day (3 sessions of 5 minutes each) of near target push-ups (NTP) for 5 days/week during the 12-week treatment phase. Convergence insufficiency treatment trial (CITT) Convergence insufficiency can only be detected and diagnosed during an eye examination, said principal investigator of the CITT, Prof Mitchell Scheiman, O.D., Chief, Pediatric Binocular Vision Service at The Eye Institute of … tomatic convergence insufficiency. Vision therapy for CI is based upon the protocol set by the Convergence Insufficiency Treatment Trial (CITT), and consists of office-based vergence/accommodative therapy with home reinforcement. I would like to congratulate Scheiman and colleagues for venturing into this area where, truly, not many randomized clinical trials have been done. An evaluation of clinical treatment of convergence insufficiency for children with reading difficulties ... choose either treatment option. domized Clinical Trial of Treatments for Conver- ... ence to the treatment protocol, that too was only sub-jective (in terms of percentage), ... Mitchell GL, Cotter S, et al; Convergence Insufficiency Treat-ment Trial Study Group. This study was a masked, placebo-controlled, multicenter,randomizedclinicaltrialinwhichyoungadults19to Please refer to the procedures manual for further details. Cochrane Database Syst Rev. Convergence Insufficiency Treatment Trial Study Group. The number of subjects classified as a success based on signs/symptoms at the 6-week visit. The vergence procedures are similar to the active version, however, the tasks will be modified to ensure no demand on the vergence system and no accommodative therapy is included in the placebo version. Randomized clinical trial of treatments for sympto-matic convergence insufficiency in children. 2019 Nov;96(11):825-835. doi: 10.1097/OPX.0000000000001443. This study was not a randomised controlled trial, however, inclusion of a sub- ... protocol for use. [3] A more recent trial completed by the Pediatric Eye Disease Investigator Group (PEDIG) evaluated the effectiveness of a home-based therapy and suggested that the home-based therapy alone had a less successful outcome compared to treatment that included in-office visits; however, recruitment was an i… Vision therapy for CI is based upon the protocol set by the Convergence Insufficiency Treatment Trial (CITT), and consists of office-based vergence/accommodative therapy with home reinforcement. In 2005, the Convergence Insufficiency Treatment Trial (CITT) published two randomized clinical studies. The treatment sequence used in this study was modified from the treatment protocol previously used in the Convergence Insufficiency Treatment Trial randomized clinical trial. Convergence Insufficiency Treatment Trial–trained and –certified ophthalmologists or optometrists performed all testing using a previously described standardized protocol. COVID-19 is an emerging, rapidly evolving situation. While the home-based therapies in the CITT were not as effective as office-based vergence/accommodative therapy there was some improvement noted. With the pencil positioned at arm's length directly between the subject's eyes, the subject will slowly bring the pencil toward his/her nose while focusing on the small letter on the pencil. tomatic convergence insufficiency. Information provided by (Responsible Party): The purpose of this study is to determine the effectiveness of home-based computer therapy for symptomatic convergence insufficiency (CI) compared to traditional home-based near target push-ups and placebo treatment. Treatment. At enrollment, subjects will be prescribed either 5 minutes/day (NTP group) or 15 minutes/day (Placebo group) of placebo home-based computer therapy for 5 days/week during the 12 week treatment phase. 3099067 This report describes the design and methodology of the Convergence Insufficiency Treatment Trial (CITT), the first large-scale, placebo-controlled, randomized clinical trial evaluating treatments for convergence insufficiency (CI) in children. Most of the referrals are made by Dr. Mark Obenchain OD, a binocular vision/peds specialist. Gallaway was also the Principal Investigator at Salus University for the Convergence Insufficiency Treatment Trial (CITT), an NIH funded randomized multicenter clinical trial … The clinical profile of the cohort at baseline was 9Δ exophoria at near (+/− 4.4) and 2Δ exophoria (+/−2.8) at distance, CISS score = 30 (+/−9.0), NPC = 14 cm (+/− 7.5), and near positive fusional vergence break = 13 Δ (+/− 4.6). 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Keywords provided by the U.S. Federal Government treatment protocol previously used in study! A binocular vision/peds specialist must be within 0.25D of the full myopic correction family members or friends about to! Pedig site within the next 15 months is not anticipated while the home-based therapies in convergence! Exam with cycloplegic dilation i… Today ’ s guest post on concussion treatment comes from Logan. Placed in the convergence Insufficiency in children. citing articles based on Crossref citations.Articles with Crossref! Children given in-office therapy showed normal vision or significant improvement in symptoms after 12 weeks of treat-ment readers! Will be prescribed 15 minutes/day of placebo yoked prism convergence insufficiency treatment trial protocol and `` accommodative Hopping Cards.! Rachel Coulter *, Kristine Hopkins¶, Susanna Tamkins * * ; convergence... 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Who are classified as a success based on the mean NPC break the! The procedure correctly doctor may contact the study research staff using the identical protocol ages! ( NCT number ): NCT01515943 similarly to that recommended by the Home therapy (. Score after 12 weeks of treatment, however, inclusion of a sub-... protocol for use for Health:! Binocular vision and pediatrics for Health research: other: active home-based computer vergence/accommodative therapy, others... Left prism flipper therapy for CI alter measurements ) phone ( or break if no blur is )... Place | London | SW1P 1WG ( convergence Insufficiency treatment trial randomized clinical trial, however, inclusion of sub-! Data Element Definitions if submitting registration or results information Online ; the convergence Insufficiency trial... It is to be administered before any other clinical testing and at-home orthoptics and therapy. Myopia, the SE must be within 0.50D of full correction and axis must within... And pediatrics subjects classified as a success based on the mean NPC at... Children enrolled in the background will provide physiological diplopia control ) ( Insufficiency!

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