convergence insufficiency treatment trial protocol

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5. By closing this message, you are consenting to our use of cookies. Convergence Insufficiency Treatment Trial–trained and –certified ophthalmologists or optometrists performed all testing using a previously described standardized protocol. 5. Methods: In a randomized clinical trial, 221 children aged 9 to 17 years with symptomatic convergence insuf-ficiency were assigned to 1 of 4 treatments. 2008; 15(1):24-36 (ISSN: 1744-5086). The number of subjects who are classified as a success based on the mean PFV blur at the 12-week visit. 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. tomatic convergence insufficiency. Today’s guest post on concussion treatment comes from Shaun Logan, DPT. Main Outcome Measures—Convergence Insufficiency Symptom Survey (CISS) score after 12 weeks of treatment. Abstract. The Convergence Insufficiency Treatment Trial (CITT) Study Group. 2008; 15(1):24-36 (ISSN: 1744-5086). 2016 Dec;93(12):1457-1465. Active home-based computer therapy will be provided the Home Therapy System (HTS) computer software and will include both fusional vergence and accommodative therapy. Arch Ophthalmol. The treatment sequence used in this study was modified from the treatment protocol previously used in the Convergence Insufficiency Treatment Trial randomized clinical trial. Parent has home phone (or access to phone) and is willing to be contacted by Jaeb Center staff. Ophthalmic Epidemiol. Treatment of Symptomatic Convergence Insufficiency in Children Enrolled in the Convergence Insufficiency Treatment Trial-Attention & Reading Trial: A Randomized Clinical Trial. Keywords provided by Jaeb Center for Health Research: Other: Active home-based computer vergence/accommodative therapy, Other: Placebo home-based computer vergence/accommodative therapy. In this report, we define this condition as a symptomatic “classic” CI, and patients who do not demonstrate all 3 signs, a “common” CI. View This Abstract Online; The convergence insufficiency treatment trial: design, methods, and baseline data. Study record managers: refer to the Data Element Definitions if submitting registration or results information. Mark Boas§, Rachel Coulter*, Kristine Hopkins¶, Susanna Tamkins**; The Convergence Insufficiency Treatment Trial Study Group ABSTRACT Purpose. Main Outcome Measures: Convergence Insuffi-ciency Symptom Survey score after 12 weeks of treat-ment. An evaluation of clinical treatment of convergence insufficiency for children with reading difficulties ... choose either treatment option. Please refer to the procedures manual for further details. 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. R. John Leigh and David S. Zee. 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. After treatment for convergence insufficiency, statistically significant improvements were found for reading comprehension (mean = 4.2, p = 0.009) and the reading composite score (mean = 2.4, p = 0.016) as measured by the Wechsler Individual Achievement Test at the 24‐week visit. 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. K. Patricia Bouweraerts, MA. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. The CBT group will be assigned active home-based computer vergence/accommodative therapy (15 minutes/day) plus placebo yoked prism flipper therapy (5 minutes/day) for a total of 20/minutes per day, 5 days per week for the 12-week treatment phase. 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). Main Outcome Measures: Convergence Insuffi-ciency Symptom Survey score after 12 weeks of treat-ment. Choosing to participate in a study is an important personal decision. In 2005, the Convergence Insufficiency Treatment Trial (CITT) published two randomized clinical studies. He accepts all insurances and Medicaid. Please refer to the procedures manual for further details. Optom Vis Sci. Our patients cover a board spectrum of demographics with approximately 2/3rds being neuro-typical and the remaining 1/3rd having an additional diagnosis such as ADHD, Autism, or other developmental delays. Treatment. 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. [2] People with convergence insufficiency often complain of the following symptoms when reading or doing intense near work: The Convergence Insufficiency Treatment Trial (CITT) is a prospective, masked, placebo-controlled, multi-center clinical trial in which 208 subjects between the ages of 9 to < 18 years will be randomly assigned to: 1) Home-based Pencil Push-Up Therapy, 2) Home-based Pencil Push-ups with Computer Vision Therapy/Orthoptics, 3) Office-based Vision Therapy/Orthoptics, or 4) Placebo Office-based Vision … Individual Participant Data (IPD) Sharing Statement: In accordance with the NIH data sharing policy, a de-identified database is placed in the public domain on the PEDIG public website after the completion of each protocol and publication of the primary manuscript. 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 … Oct 2008;126(10):1336-1349. For hyperopia, the spherical component can be reduced by up to 1.50D at investigator discretion provided the reduction is symmetrical and results in residual (i.e., uncorrected) SE hyperopia that does not exceed +2.00D. [ 30, 35] Follow-up depends on the severity … Pediatric Eye Disease Investigator Group. Previous CITT Study. Addressing some of the limitations of previous studies, the Convergence Insufficiency Treatment Trial Investigator Group conducted a pilot study to evaluate the impact of vergence/accommodative therapy on reading performance in children with symptomatic convergence insufficiency. 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). 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- 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 … 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. The number of subjects classified as a success based on signs/symptoms at the 6-week visit. Astigmatism > 1.00D or > 1.50D of meridional difference in either eye Refractive correction for patients meeting the above refractive error criteria must meet the following guidelines: SE anisometropia must be within 0.25D of the full anisometropic correction. Astigmatism cylinder must be within 0.50D of full correction and axis must be within 5 degrees. Randomized clinical trial of treatments for sympto-matic convergence insufficiency in children. At that time the group used the acronym CIRS (Convergence Insufficiency Reading Study). We use cookies to improve your website experience. Figure 2 outlines the treatment sequence. Methods: In a randomized clinical trial, 221 children aged 9 to 17 years with symptomatic convergence insuf-ficiency were assigned to 1 of 4 treatments. The convergence insufficiency treatment trial: design, methods, and baseline data. Methods: In a randomized clinical trial, 221 children aged 9 to 17 years with symptomatic convergence insufficiency were assigned to 1 of 4 treatments. The number of subjects classified as a success based on signs/symptoms at the 12-week visit. Read our, ClinicalTrials.gov Identifier: NCT01515943, Interventional •Surgical Care: Eye muscle surgery should only be considered with a licensed eye care specialist’s recommendation (Cooper, 2001 -2005). 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. Subjects will be prescribed 5 minutes/day of placebo yoked prism flipper therapy for 5 days/week during the 12 week treatment phase. Relocation outside of area of an active PEDIG site within the next 15 months is not anticipated. The Convergence Insufficiency Treatment Trial (CITT) study groupdesignedthispilotstudyinpreparationforalargerrandom-ized clinical trial. For general information, Learn About Clinical Studies. Methods—In a randomized clinical trial, 221 children 9 to 17 years with symptomatic CI were assigned to one of four treatments. The study had well-defined eligibility criteria, a standardized treatment protocol administered by trained therapists, and … 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. Weeks 1-4: View the target through prism flippers, Weeks 5-8: Wear red-blue filter glasses while viewing the text through prism flippers, Weeks 9-12: Wear polaroid glasses while viewing the text through prism flippers, Treatment Group Comparison of the Percentage of Participants Classified as an Overall Success at 12 Weeks - HB-C Versus HB-PU [ Time Frame: 12 weeks after randomization (baseline) ], Convergence Insufficiency Symptom Survey (CISS): 12-week score <16 points and at least 9-point improvement from baseline at 12 weeks, Near point of convergence (NPC) break: 12-week/baseline mean NPC break <0.763 and a mean 12-week NPC break <6 cm, Positive fusional vergence (PFV) blur: 12-week/baseline mean PFV blur >1.419 and a mean 12-week PFV break >15 pd, Treatment Group Comparison of the Percentage of Participants Classified as an Overall Success at 12 Weeks - HB-C Versus HB-P [ Time Frame: 12-weeks after randomization (baseline) ], Number of Participants Classified as Having Met Success Criteria Based on CI Signs/Symptoms at 12 Weeks by Treatment Group [ Time Frame: 12 weeks after randomization (baseline) ], Number of Participants Classified as Having Met Success Criteria Based on the Mean NPC Break at 12 Weeks by Treatment Group [ Time Frame: 12 weeks after randomization (baseline) ], Number of Participants Classified as Having Met Success Criteria Based on the Mean PFV Blur at 12 Weeks by Treatment Group [ Time Frame: 12 weeks after randomization (baseline) ], Number of Participants Classified as Having Met Success Criteria for Both Clinical Measures at 12 Weeks by Treatment Group [ Time Frame: 12-weeks after randomization (baseline) ], Near point of convergence (NPC) break: 12-week/baseline mean NPC break <0.763 and a 12-week mean NPC break <6 cm, Positive fusional vergence (PFV) blur: 12-week/baseline mean PFV blur >1.419 and a 12-week mean PFV blur >15 pd, Number of Participants Classified as Having Improved in All 3 Outcomes Measures From Baseline to 12 Weeks by Treatment Group [ Time Frame: 12 weeks after randomization (baseline) ], Convergency Insufficiency Symptom Survey (CISS): Improvement of 9 or more points since baseline, Near point of convergence (NPC) break: 12-week/baseline mean NPC break <0.763, Positive fusional vergence (PFV) blur: 12-week/ baseline mean PFV blur >1.419, Number of Participants Classified as an Overall Success Based on the 3 Outcomes Measures From Baseline to 6 Weeks by Treatment Group [ Time Frame: 6 weeks after randomization (baseline) ], Convergence Insufficiency Symptom Survey (CISS): 6-week score <16 points and at least 9-point improvement from baseline at 6 weeks, Near point of convergence (NPC) break: 6-week/baseline mean NPC break <0.763 and a mean 6-week NPC break <6 cm, Positive fusional vergence (PFV) blur: 6-week/baseline mean PFV blur >1.419 and a mean 6-week PFV break >15 pd, Number of Participants Classified as Having Met Success Criteria Based on CI Signs/Symptoms at 6 Weeks by Treatment Group [ Time Frame: 6 weeks after randomization (baseline) ], Number of Participants Classified as Having Met Success Criteria Based on the Mean NPC Break at 6 Weeks by Treatment Group [ Time Frame: 6 weeks after randomization (baseline) ], Number of Participants Classified as Having Met Success Criteria Based on the Mean PFV Blur at 6 Weeks by Treatment Group [ Time Frame: 6 weeks after randomization (baseline) ], Number of Participants Classified as Having Met Success Criteria for Both Clinical Measures at 6 Weeks by Treatment Group [ Time Frame: 6-weeks after randomization (baseline) ], Near point of convergence (NPC) break: 6-week/baseline mean NPC break <0.763 and a 6-week mean NPC break <6 cm, Positive fusional vergence (PFV) blur: 6-week/baseline mean PFV blur >1.419 and a 6-week mean PFV blur >15 pd, Number of Participants Classified as Having Improved in All 3 Outcomes Measures From Baseline to 6 Weeks by Treatment Group [ Time Frame: 6 weeks after randomization (baseline) ], Near point of convergence (NPC) break: 6-week/baseline mean NPC break <0.763, Positive fusional vergence (PFV) blur: 6-week/baseline mean PFV blur >1.419, Patient has access to a computer with a CD/DVD drive and internet access for the next 12 weeks, Best-corrected visual acuity of ≥20/25 in each eye at distance and near, Exophoria at near at least 4 pd greater than at distance. , and baseline data reported herein define the clinical profile of those enrolled into the CITT function of.... 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Therapy for CI myopic correction and near vergence techniques from the treatment sequence in... 11 ):825-835. doi: 10.1097/OPX.0000000000001443, many eye care professionals only offer home-based therapy, Inc. ) citing based! ) ( Gallaway, 2002 ) ( Gallaway, 2002 ) ( Convergency Insufficiency treatment Trial-Attention & trial. Clinical and demographic characteristics of patients an important personal decision listing a study is an important personal decision axis.

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