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Trial record 1 of 1 for:    SAS1
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A Prospective Observational Study of Adult Strabismus (SAS1)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by Jaeb Center for Health Research
Sponsor:
Collaborators:
Pediatric Eye Disease Investigator Group
National Eye Institute (NEI)
Information provided by (Responsible Party):
Jaeb Center for Health Research
ClinicalTrials.gov Identifier:
NCT02510040
First received: July 24, 2015
Last updated: June 24, 2016
Last verified: June 2016
  Purpose
The purpose of this study is to describe clinical characteristics, treatments, and one-year outcomes of adults with convergence insufficiency, divergence insufficiency, or small angle hypertropia.

Condition Intervention
Convergence Insufficiency
Divergence Insufficiency
Hypertropia
Device: Prism
Other: Orthoptic Exercises
Procedure: Eye Muscle Surgery
Procedure: Botox Injection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Observational Study of Adult Strabismus

Resource links provided by NLM:


Further study details as provided by Jaeb Center for Health Research:

Primary Outcome Measures:
  • Symptom Success at 10 Weeks [ Time Frame: 10 weeks after enrollment ]
    In the convergence insufficiency group, the primary outcome will be symptom success at the 10-week and 12-month visit, defined as improvement of CI Symptom Survey (CISS) score of at least 9 points and an outcome score of <21 points. In the divergence insufficiency group, the primary outcome will be symptom success at the 10-week and 12-month visit, defined as diplopia "rarely" or "never" in primary position at distance on the diplopia questionnaire. In the small-angle hypertropia group, the primary outcome will be symptom success at the 10-week and 12-month visit, defined as diplopia "rarely" or "never" both in primary position at distance and in reading position on the diplopia questionnaire.

  • Symptom Success at 12 Months [ Time Frame: 12 months after enrollment ]
    In the convergence insufficiency group, the primary outcome will be symptom success at the 10-week and 12-month visit, defined as improvement of CI Symptom Survey (CISS) score of at least 9 points and an outcome score of <21 points. In the divergence insufficiency group, the primary outcome will be symptom success at the 10-week and 12-month visit, defined as diplopia "rarely" or "never" in primary position at distance on the diplopia questionnaire. In the small-angle hypertropia group, the primary outcome will be symptom success at the 10-week and 12-month visit, defined as diplopia "rarely" or "never" both in primary position at distance and in reading position on the diplopia questionnaire.


Secondary Outcome Measures:
  • Motor alignment [ Time Frame: 12 months after enrollment ]
  • Near point of convergence [ Time Frame: 12 months after enrollment ]
    Near point of convergence (convergence insufficiency group only)

  • Positive fusional vergence [ Time Frame: 12 months after enrollment ]
    Positive fusional vergence (convergence insufficiency group only)

  • Negative fusional vergence [ Time Frame: 12 months after enrollment ]
    Negative fusional vergence (divergence insufficiency group only)

  • Vertical fusional vergence [ Time Frame: 12 months after enrollment ]
    Vertical fusional vergence (small-angle hypertropia group only)

  • Adult Strabismus 20 Questionnaire Score [ Time Frame: 12 months after enrollment ]
  • Mean Convergence Insufficiency Symptom Survey Score [ Time Frame: 12 months after enrollment ]
    Mean Convergence Insufficiency Symptom Survey Score (convergence insufficiency group only)


Estimated Enrollment: 650
Study Start Date: August 2015
Estimated Study Completion Date: August 2019
Estimated Primary Completion Date: August 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Convergence insufficiency
Eligible adults with convergence insufficiency can be treated with prism, orthoptic exercises, eye muscle surgery, or botox injection, per the investigator's usual clinical practice.
Device: Prism
Ground-in or Fresnel prism
Other: Orthoptic Exercises
Orthoptic exercises- fusion, convergence, divergence, and others, including computer-based therapy
Procedure: Eye Muscle Surgery
  • Bilateral medial rectus muscle resection surgery
  • Single medial rectus muscle resection surgery
  • Recess lateral rectus muscle resection medial rectus muscle surgery
  • Bilateral lateral rectus muscle recession surgery
  • Single lateral rectus muscle recession surgery
  • Bilateral lateral rectus muscle resection surgery
  • Single lateral rectus muscle resection surgery
  • Recess medial rectus muscle resection lateral rectus muscle surgery
  • Bilateral medial rectus muscle recession surgery
  • Single medial rectus muscle recession surgery
  • Vertical rectus muscle recession surgery
  • Vertical rectus muscle mini-tenotomy (snip) surgery
Procedure: Botox Injection
Botulinum toxin injection
Other Name: Botulinum toxin injection
Divergence insufficiency
Eligible adults with divergence insufficiency can be treated with prism, orthoptic exercises, eye muscle surgery, or botox injection, per the investigator's usual clinical practice.
Device: Prism
Ground-in or Fresnel prism
Other: Orthoptic Exercises
Orthoptic exercises- fusion, convergence, divergence, and others, including computer-based therapy
Procedure: Eye Muscle Surgery
  • Bilateral medial rectus muscle resection surgery
  • Single medial rectus muscle resection surgery
  • Recess lateral rectus muscle resection medial rectus muscle surgery
  • Bilateral lateral rectus muscle recession surgery
  • Single lateral rectus muscle recession surgery
  • Bilateral lateral rectus muscle resection surgery
  • Single lateral rectus muscle resection surgery
  • Recess medial rectus muscle resection lateral rectus muscle surgery
  • Bilateral medial rectus muscle recession surgery
  • Single medial rectus muscle recession surgery
  • Vertical rectus muscle recession surgery
  • Vertical rectus muscle mini-tenotomy (snip) surgery
Procedure: Botox Injection
Botulinum toxin injection
Other Name: Botulinum toxin injection
Small-angle hypertropia
Eligible adults with small-angle hypertropia can be treated with prism, orthoptic exercises, eye muscle surgery, or botox injection, per the investigator's usual clinical practice.
Device: Prism
Ground-in or Fresnel prism
Other: Orthoptic Exercises
Orthoptic exercises- fusion, convergence, divergence, and others, including computer-based therapy
Procedure: Eye Muscle Surgery
  • Bilateral medial rectus muscle resection surgery
  • Single medial rectus muscle resection surgery
  • Recess lateral rectus muscle resection medial rectus muscle surgery
  • Bilateral lateral rectus muscle recession surgery
  • Single lateral rectus muscle recession surgery
  • Bilateral lateral rectus muscle resection surgery
  • Single lateral rectus muscle resection surgery
  • Recess medial rectus muscle resection lateral rectus muscle surgery
  • Bilateral medial rectus muscle recession surgery
  • Single medial rectus muscle recession surgery
  • Vertical rectus muscle recession surgery
  • Vertical rectus muscle mini-tenotomy (snip) surgery
Procedure: Botox Injection
Botulinum toxin injection
Other Name: Botulinum toxin injection

Detailed Description:
The purpose of this study is to describe clinical characteristics, treatments, and one-year outcomes of adults with convergence insufficiency, divergence insufficiency, or small angle hypertropia. Treatment comparisons within the studied conditions will also be done to help develop future studies.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Community Sample
Criteria

Eligibility Criteria for Convergence Insufficiency (CI) Group:

The following criteria must be met for the subject to be enrolled into the study:

  • Adults ≥18 years of age (adult onset of CI not required)
  • No strabismus surgery within the past 10 years
  • CI Symptom Survey score ≥21 points
  • Near exodeviation of ≥4∆ and at least 4∆ larger than at distance by PACT
  • Distance exodeviation ≤15∆ by PACT
  • Vertical deviation ≤2∆ at distance and near by PACT
  • No constant exotropia at distance or near
  • Reduced positive fusional vergence (PFV) at near (<20∆ or fails Sheard's criterion that the PFV measures less than twice the magnitude of the near phoria)
  • Near point of convergence (NPC) of ≥6 cm break
  • Visual acuity 20/50 or better in both eyes by ETDRS or Snellen
  • No paralytic strabismus (e.g., 3rd, 4th, or 6th cranial nerve palsies, skew deviation, Duane syndrome)
  • No restrictive strabismus (e.g., blowout fracture, thyroid eye disease, post scleral buckle, Brown syndrome)
  • No monocular diplopia
  • No paretic strabismus, thyroid eye disease, myasthenia gravis, chronic progressive external ophthalmoplegia, or eye movement abnormalities associated with known neurological disease. Patients with Parkinson's disease can be enrolled if non-paretic deviation.
  • No inferior or superior oblique overaction defined as 2+ or greater
  • Ability to fuse with prism in space (see section 2.4.1)
  • Ability to understand and complete a survey
  • Investigator is initiating treatment with prism, orthoptic exercises, botulinum toxin injection or surgery
  • If initiating treatment with botulinum toxin or surgery, planned injection or surgery to be within 60 days of enrollment
  • Single treatment modality is planned (e.g., no combined prism and orthoptic exercises)
  • Treatment to be initiated has not been used within the past one year

Eligibility Criteria for Divergence Insufficiency (DI) Group:

The following criteria must be met for the subject to be enrolled into the study:

  • Adults ≥18 years of age
  • Adult-onset DI (at ≥18 years of age)
  • No prior strabismus surgery
  • Symptoms of diplopia at distance with a frequency of sometimes or worse in primary position (in current glasses if wearing glasses)
  • Distance esodeviation of 2∆ to 30∆ and at least 50% larger than at near by PACT
  • No more than 5∆ difference between right and left gaze by PACT
  • No more than 10∆ difference between the primary position at distance and either upgaze or downgaze ≤10∆ by PACT
  • Any coexisting vertical deviation must be less than distance esodeviation and ≤10∆ by PACT
  • Visual acuity 20/50 or better in both eyes by ETDRS or Snellen
  • No paralytic strabismus (e.g., 3rd, 4th, or 6th cranial nerve palsies, skew deviation, Duane syndrome)
  • No restrictive strabismus (e.g., blowout fracture, thyroid eye disease, post scleral buckle, Brown syndrome)
  • No monocular diplopia
  • No paretic strabismus, thyroid eye disease, myasthenia gravis, chronic progressive external ophthalmoplegia, or eye movement abnormalities associated with known neurological disease. Patients with Parkinson's disease can be enrolled if non-paretic deviation
  • No inferior or superior oblique overaction defined as 2+ or greater
  • Ability to fuse with prism in space (see section 2.4.2)
  • Ability to understand and complete a survey
  • Investigator is initiating treatment with prism, orthoptic exercises, botulinum toxin injection or surgery
  • If initiating treatment with botulinum toxin or surgery, planned injection or surgery to be within 60 days of enrollment
  • Single treatment modality planned (e.g., no combined prism and orthoptic exercises)
  • Treatment to be initiated has not been used within the past one year

Eligibility Criteria for Small-angle Hypertropia (HT) Group:

The following criteria must be met for the subject to be enrolled into the study:

  • Adults ≥18 years of age
  • Adult-onset HT (at ≥18 years of age)
  • No prior strabismus surgery
  • Symptoms of diplopia at distance or near with a frequency of sometimes or worse in primary or reading position (in current glasses if wearing glasses)
  • Vertical deviation ≥1∆ to ≤10∆ at distance and near by PACT
  • No more than 4∆ difference from the primary in any gaze position by PACT
  • Any coexisting esodeviation must be less than the vertical deviation
  • Any coexisting exodeviation ≤10∆ by PACT
  • No convergence insufficiency as defined in section 2.2.1
  • Visual acuity 20/50 or better in both eyes by ETDRS or Snellen
  • No paralytic strabismus (e.g., 3rd, 4th, or 6th cranial nerve palsies, skew deviation, Duane syndrome)
  • No restrictive strabismus (e.g., blowout fracture, thyroid eye disease, post scleral buckle, Brown syndrome)
  • No monocular diplopia
  • No paretic strabismus, thyroid eye disease, myasthenia gravis, chronic progressive external ophthalmoplegia, or eye movement abnormalities associated with known neurological disease. Patients with Parkinson's disease can be enrolled if non-paretic deviation.
  • No inferior or superior oblique overaction defined as 2+ or greater
  • Ability to fuse with prism in space (see section 2.4.3)
  • Ability to understand and complete a survey
  • Investigator is initiating treatment with prism, orthoptic exercises, botulinum toxin injection or surgery
  • If initiating treatment with botulinum toxin or surgery, planned injection or surgery to be within 60 days of enrollment
  • Single treatment modality planned (e.g., no combined prism and orthoptic exercises)
  • Treatment to be initiated has not been used within the past one year
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02510040

Contacts
Contact: Raymond Kraker, MSPH 813-975-8690 rkraker@jaeb.org
Contact: Jennifer Shah 8139758690 pedig@jaeb.org

Locations
United States, Virginia
Earl R. Crouch, III Recruiting
Norfolk, Virginia, United States, 23502-3942
Contact: Earl R. Crouch, III, M.D.    757-461-0050      
Principal Investigator: Earl R. Crouch, III, M.D.         
Sponsors and Collaborators
Jaeb Center for Health Research
Pediatric Eye Disease Investigator Group
National Eye Institute (NEI)
Investigators
Study Chair: Earl R Crouch, III, MD Virginia Pediatric Eye Center
  More Information

Additional Information:
Responsible Party: Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT02510040     History of Changes
Other Study ID Numbers: SAS1
2U10EY011751 ( US NIH Grant/Contract Award Number )
Study First Received: July 24, 2015
Last Updated: June 24, 2016
Individual Participant Data  
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.

Keywords provided by Jaeb Center for Health Research:
Convergence Insufficiency
Divergence Insufficiency
Small-angle Hypertropia
Strabismus

Additional relevant MeSH terms:
Strabismus
Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases
Central Nervous System Diseases
Botulinum Toxins
onabotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2017