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Convergence Insufficiency Treatment Study (CITS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01515943
Recruitment Status : Completed
First Posted : January 24, 2012
Results First Posted : August 5, 2016
Last Update Posted : April 12, 2017
Sponsor:
Collaborators:
Pediatric Eye Disease Investigator Group
National Eye Institute (NEI)
Information provided by (Responsible Party):
Jaeb Center for Health Research

Tracking Information
First Submitted Date  ICMJE January 19, 2012
First Posted Date  ICMJE January 24, 2012
Results First Submitted Date  ICMJE May 2, 2016
Results First Posted Date  ICMJE August 5, 2016
Last Update Posted Date April 12, 2017
Study Start Date  ICMJE June 2012
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 9, 2017)
  • 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) ]
    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%). Overall success was defined as meeting all of the following criteria at 12 weeks:
    1. Convergence Insufficiency Symptom Survey (CISS): 12-week score <16 points and at least 9-point improvement from baseline at 12 weeks
    2. Near point of convergence (NPC) break: 12-week/baseline mean NPC break <0.763 and a mean 12-week NPC break <6 cm
    3. 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) ]
    Pairwise treatment group comparison (HB-C versus Placebo) 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. Overall success was defined as meeting all of the following criteria at 12 weeks:
    1. Convergence Insufficiency Symptom Survey (CISS): 12-week score <16 points and at least 9-point improvement from baseline at 12 weeks
    2. Near point of convergence (NPC) break: 12-week/baseline mean NPC break <0.763 and a mean 12-week NPC break <6 cm
    3. Positive fusional vergence (PFV) blur: 12-week/baseline mean PFV blur >1.419 and a mean 12-week PFV break >15 pd
Original Primary Outcome Measures  ICMJE
 (submitted: January 19, 2012)
  • Successful treatment of CI for CBT versus NTP comparison [ Time Frame: 12 weeks after randomization ]
    A treatment comparison of the proportion of subjects who are successfully treated for CI at the 12-week visit using logistic regression analysis, adjusting for baseline covariates.
  • Successful treatment of CI for CBT versus placebo comparison [ Time Frame: 12-weeks after randomization ]
    A treatment comparison of the proportion of subjects who are successfully treated for CI at the 12-week visit using logistic regression analysis, adjusting for baseline covariates.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2017)
  • 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) ]
    The number of subjects classified as a success based on signs/symptoms at the 12-week visit. Success is based on the Convergency Insufficiency Symptom Survey (CISS) defined as improvement of 9 or more points from baseline and a 12-week score of <16 points.
  • 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) ]
    The number of subjects who are classified as a success based on the mean NPC break at the 12-week visit. Success is based on the mean NPC (near point of convergence) break is defined as having a mean NPC break of <6 cm at 12 weeks and a 12-week to baseline ratio of <0.763 for mean NPC break.
  • 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) ]
    The number of subjects who are classified as a success based on the mean PFV blur at the 12-week visit. Success is based on the mean PFV (positive fusional vergence) blur, defined as having a mean PFV blur of >15 pd at 12 weeks and a 12-week to baseline ratio of >1.419 for mean PFV blur.
  • 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) ]
    The number of subjects classified as a success based on clinical measures of CI (mean NPC break & mean PFV blur) at the 12-week visit. Clinical success is defined according to whether both criteria (below) are met as follows:
    1. Near point of convergence (NPC) break: 12-week/baseline mean NPC break <0.763 and a 12-week mean NPC break <6 cm
    2. 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) ]
    Improvement in all 3 outcome measures at 12 weeks will be defined as follows:
    1. Convergency Insufficiency Symptom Survey (CISS): Improvement of 9 or more points since baseline
    2. Near point of convergence (NPC) break: 12-week/baseline mean NPC break <0.763
    3. Positive fusional vergence (PFV) blur: 12-week/ baseline mean PFV blur >1.419
    (Note: All 3 criteria must be met in order to be classified as an "improver" at the 12-week primary outcome visit).
  • 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) ]
    To be considered an overall success, each of the following criteria must be met for the 3 outcome measures at 6 weeks:
    1. Convergence Insufficiency Symptom Survey (CISS): 6-week score <16 points and at least 9-point improvement from baseline at 6 weeks
    2. Near point of convergence (NPC) break: 6-week/baseline mean NPC break <0.763 and a mean 6-week NPC break <6 cm
    3. Positive fusional vergence (PFV) blur: 6-week/baseline mean PFV blur >1.419 and a mean 6-week PFV break >15 pd
    (Note: All 3 criteria must be met in order to be classified as an overall success at the 6-week visit).
  • 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) ]
    The number of subjects classified as a success based on signs/symptoms at the 6-week visit. Success is based on the Convergency Insufficiency Symptom Survey (CISS) defined as improvement of 9 or more points from baseline and a 6-week score of <16 points.
  • 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) ]
    The number of subjects who are classified as a success based on the mean NPC break at the 6-week visit. 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.
  • 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) ]
    The number of subjects who are classified as a success based on the mean PFV blur at the 6-week visit. 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.
  • 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) ]
    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. Clinical success is defined according to whether both criteria (below) are met as follows:
    1. Near point of convergence (NPC) break: 6-week/baseline mean NPC break <0.763 and a 6-week mean NPC break <6 cm
    2. 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) ]
    Improvement in all 3 outcome measures at 6 weeks will be defined as follows:
    1. Convergency Insufficiency Symptom Survey (CISS): Improvement of 9 or more points since baseline
    2. Near point of convergence (NPC) break: 6-week/baseline mean NPC break <0.763
    3. Positive fusional vergence (PFV) blur: 6-week/baseline mean PFV blur >1.419
    (Note: All 3 criteria must be met in order to be classified as an "improver" at the 6-week visit).
Original Secondary Outcome Measures  ICMJE
 (submitted: January 19, 2012)
  • Successful treatment of CI for NTP versus placebo comparison [ Time Frame: 12 weeks after randomization ]
    A treatment comparison of the proportion of subjects who are successfully treated for CI at the 12-week visit using logistic regression analysis, adjusting for baseline covariates.
  • Improvement in all outcome measures (CISS, NPC, PFV) [ Time Frame: 12 weeks after randomization ]
    Treatment group comparisons of the proportion of subjects with improvement in all outcome measures (CISS, NPC, PFV) at the 12 week visit using logistic regresion, adjusting for baseline ccovariates.
  • Treatment comparisons of successful treatment of CI based on objective measures [ Time Frame: 12-weeks after randomization ]
    Treatment comparisons of the proportion of subjects who are successfully treated for CI based on objective measures (NPC, PFV) at the 12-week visit using logistic regression analysis, adjusting for baseline covariates.
  • Treatment comparisons of successful treatment of CI based on symptoms [ Time Frame: 12 weeks after randomization ]
    Treatment comparisons of the proportion of subjects who are successfully treated for CI based on the CI symptom survey (CISS) at the 12-week visit using logistic regression analysis, adjusting for baseline covariates.
  • Proportion of subjects with a CI recurrence after discontinuing treatment [ Time Frame: 6 months and 12 months after the 12-week visit ]
    An estimate and 95% confidence interval will be computed using the exact binomial method to determine the overall and treatment group proportion of subjects with a CI recurrence at the 6- and 12-month post-treatment exams.
  • Successful treatment of CI according to subgroup factors [ Time Frame: 12 weeks after randomization ]
    Exploratory analyses will be utilized to assess treatment group differences in success proportions within predefined subgroups according to baseline factors. Interpretation of subgroup analyses will depend on whether the group comparisons of CBT versus active NTP or CBT versus placebo therapy demonstrate a significant treatment group difference.
  • Evaluate successful treatment of CI on ADHD signs/symptoms [ Time Frame: 12 weeks after randomization ]
    The purpose of this objective is to determine if successful treatment of CI reduces the reported symptoms/signs of ADHD as measured by the SWAN questionnaire. An analysis of covariance (ANCOVA) will be performed to compare mean scores at 12-weeks for those who meet success criteria versus those who do not at the outcome exam, adjusting for baseline scores.
  • Evaluate treatment group differences in ADHD signs/symptoms [ Time Frame: 12 weeks after randomization ]
    The purpose of this objective will be to perform a treatment comparison of the 12-week symptoms/signs of ADHD as measured by the SWAN questionnaire. An analysis of covariance (ANCOVA) will be performed to compare mean scores at 12-weeks by treatment group, adjusting for baseline scores. If there is a statistically significant treatment effect (F-test, p < 0.05), the Tukey-Kramer procedure for multiple pair-wise comparisons will be employed to perform the treatment group comparisons.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Convergence Insufficiency Treatment Study (CITS)
Official Title  ICMJE Effectiveness of Home-Based Therapy for Symptomatic Convergence Insufficiency
Brief Summary 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.
Detailed Description

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. 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. 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.

While the home-based therapies in the CITT were not as effective as office-based vergence/accommodative therapy there was some improvement noted. Currently, many eye care professionals only offer home-based therapy, while others suggest passive treatment with base-in prism. 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.

There are significant differences in contact time, complexity, and cost between office-based and home-based therapy for CI. Many clinicians believe that the less costly and less complex treatment option should be attempted first. Although home-based therapy using computer software is becoming more popular, no prospective data are available to demonstrate the effectiveness of home-based vision therapy using computer software compared to home-based near target push-ups or home-based placebo computer therapy. A prospective clinical trial is therefore needed to determine the effectiveness of home-based computer therapy for symptomatic CI compared to traditional home-based near target push-ups and placebo treatment.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Convergence Insufficiency
Intervention  ICMJE
  • Other: Active home-based computer vergence/accommodative therapy
    At enrollment, subjects will be prescribed 15 minutes/day of active home-based computer therapy for 5 days/week during the 12 week treatment phase. Active home-based computer therapy will be provided the Home Therapy System (HTS) computer software and will include both fusional vergence and accommodative therapy. Subjects will perform the computer therapy while wearing red/blue glasses and accommodative therapy will be performed using the HTS accommodative flippers. Please refer to the procedures manual for further details.
    Other Name: Home Therapy System (HTS, Home Vision Therapy, Inc.)
  • Procedure: Near target push-ups
    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. An alphabet pencil will be used as the target and an index card placed in the background will provide physiological diplopia control. 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. 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. This procedure will be repeated several times. Please refer to the procedures manual for further details.
    Other Name: Pencil push-ups
  • Other: Placebo home-based computer vergence/accommodative therapy
    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. Placebo computer-based therapy will be provided by the Home Therapy System (HTS) computer software. 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. Please refer to the procedures manual for further details.
    Other Name: Home Therapy System (HTS, Home Vision Therapy, Inc.)
  • Procedure: Placebo yoked prism flippers

    Subjects will be prescribed 5 minutes/day of placebo yoked prism flipper therapy for 5 days/week during the 12 week treatment phase. This procedure utilizes a 4 pd base right/4 pd base left prism flipper and "Accommodative Hopping Cards". Subjects view the text on the card through the prisms at 40 cm, perform the appropriate task and then flip the prism flipper to the other side after each word before proceeding to the next line. Please refer to the procedures manual for further details. The task remains constant, but the nature of the procedure changes with time:

    • 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
Study Arms  ICMJE
  • Active Comparator: Computer-based therapy (CBT)
    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.
    Interventions:
    • Other: Active home-based computer vergence/accommodative therapy
    • Procedure: Placebo yoked prism flippers
  • Active Comparator: Near target push-up (NTP)
    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.
    Interventions:
    • Procedure: Near target push-ups
    • Other: Placebo home-based computer vergence/accommodative therapy
  • Placebo Comparator: Placebo
    The placebo group will be assigned placebo 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.
    Interventions:
    • Other: Placebo home-based computer vergence/accommodative therapy
    • Procedure: Placebo yoked prism flippers
Publications * Pediatric Eye Disease Investigator Group. Home-Based Therapy for Symptomatic Convergence Insufficiency in Children: A Randomized Clinical Trial. Optom Vis Sci. 2016 Dec;93(12):1457-1465.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 18, 2014)
204
Original Estimated Enrollment  ICMJE
 (submitted: January 19, 2012)
600
Actual Study Completion Date  ICMJE January 2015
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age: 9 to <18 years
  2. Patient has access to a computer with a CD/DVD drive and internet access for the next 12 weeks
  3. Best-corrected visual acuity of ≥20/25 in each eye at distance and near
  4. Exophoria at near at least 4 pd greater than at distance
  5. Reduced positive fusional convergence at near (<20 pd or fails Sheard's criterion that the PFV measures less than twice the magnitude of the near phoria). PFV is recorded as the prism magnitude where vision is first blurred (or break if no blur is reported).
  6. Near point of convergence of ≥6 cm break
  7. Randot Preschool stereoacuity of at least 400 seconds of arc
  8. CI Symptom Survey score ≥16
  9. No use of a plus add for near or base-in prism for at least 2 weeks preceding enrollment
  10. 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:

    • Myopia more than -0.75D spherical equivalent (SE) in either eye
    • Hyperopia more than +2.00D SE in either eye
    • SE anisometropia >1.00D
    • 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.
    • 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.
    • For myopia, the SE must be within 0.25D of the full myopic correction.
  11. Parent and patient understand the protocol and are willing to accept randomization.
  12. Parent has home phone (or access to phone) and is willing to be contacted by Jaeb Center staff.
  13. Relocation outside of area of an active PEDIG site within the next 15 months is not anticipated.

Exclusion Criteria:

  1. ≥2 logMAR line difference in best-corrected visual acuity between the two eyes
  2. Constant or intermittent exotropia at distance; constant exotropia at near
  3. Any esotropia at distance or near
  4. Distance exophoria > 10 pd
  5. History of strabismus surgery
  6. Anisometropia ≥2.00D in any meridian between the eyes
  7. Prior intraocular or refractive surgery
  8. Primary vertical heterophoria greater than 1 pd
  9. Diseases known to affect accommodation, vergence, and ocular motility such as multiple sclerosis, Graves orbitopathy, myasthenia gravis, diabetes mellitus, or Parkinson disease
  10. Current use of any ocular or systemic medication known to affect accommodation or vergence such as anti-anxiety agents (e.g., Librium or Valium), anti-arrhythmic agents (e.g., Cifenline, Cibenzoline), anti- cholinergics (e.g., Motion sickness patch (scopolamine), bladder spasmolytic drugs (e.g., Propiverine), hydroxychloroquine, chloroquine, phenothiazines (e.g., Compazine, Mellaril, Thorazine), tricyclic antidepressants (e.g., Elavil, Nortriptyline, Tofranil)
  11. Near point of accommodation >20 cm in the right eye
  12. Manifest or latent nystagmus evident clinically
  13. History of chronic headaches unrelated to reading activity
  14. Active symptomatic allergic conjunctivitis
  15. Developmental disability, mental retardation, attention deficit hyperactivity disorder (ADHD), or learning disability diagnosis that in the investigator's discretion would interfere with treatment or evaluation
  16. Household member or sibling already enrolled in the CITS OR previously enrolled in the CITT
  17. Household member is an eye professional, ophthalmic technician, ophthalmology or optometry resident, orthoptist, or optometry student, or employed in an eye care setting
  18. Acquired brain injury
  19. Previous office- or home-based vision therapy, orthoptics, home-based near- target push-ups, pencil push-ups, or home-based computer therapy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 9 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01515943
Other Study ID Numbers  ICMJE CITS
2U10EY011751 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: 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.
Responsible Party Jaeb Center for Health Research
Study Sponsor  ICMJE Jaeb Center for Health Research
Collaborators  ICMJE
  • Pediatric Eye Disease Investigator Group
  • National Eye Institute (NEI)
Investigators  ICMJE
Study Chair: Mitchell M Scheiman, OD Jaeb Center for Health Research
Study Chair: Darren L Hoover, MD Jaeb Center for Health Research
PRS Account Jaeb Center for Health Research
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP