A Study of Clinical Characteristics, Treatments, and One-Year Outcomes of Adults with Strabismus

Overview

  • Study type

    Observational
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 15-005768
    NCT ID: NCT02510040
    Sponsor Protocol Number: 15005768

About this study

The purpose of this study is to describe clinical characteristics, treatments, and one-year outcomes for adults who have convergence insufficiency, divergence insufficiency, or small angle hypertropia.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria 

  • Convergence Insufficiency Group
    • 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 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 
    • 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
  • Divergence Insufficiency Group
    • Adults ≥18 years of age
    • Adult-onset Divergence insufficiency 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
      • 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 
    • Ability to understand and complete a survey
    • Investigator is initiating treatment with prism, orthoptic exercises, botulinum toxin injection or surgery
    • If 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
  • Small-angle Hypertropia Group
    • 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
    • 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
      • Parkinson's disease can be enrolled if of non-paretic deviation
    • No inferior or superior oblique overaction defined as 2+ or greater
    • Ability to fuse with prism in space
    • 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

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Jonathan Holmes, M.D.

Open for enrollment

Contact information:

Suzanne Wernimont CCRP

(507)266-4326

Wernimont.Suzanne@mayo.edu

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CLS-20264110

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