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N/A N=217

A Prospective Observational Study of Adult Strabismus

Convergence Insufficiency · Divergence Insufficiency · Hypertropia

Enrolled (actual)
217
Serious AEs
Results posted
Apr 2021
Primary outcome: Primary: Number of Participants With Symptom Success at 10 Weeks — 25; 91; 12 Participants

Study Design & Population

Study type
Observational
Phase
N/A
Interventions
Prism (Device); Orthoptic Exercises (Other); Eye Muscle Surgery (Procedure); Botox Injection (Procedure)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Jaeb Center for Health Research
Primary completion
Dec 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Symptom Success at 10 Weeks
25; 91; 12
PRIMARY
Number of Participants With Symptom Success at 12 Months
25; 73; 6
SECONDARY
Mean of Near Point of Convergence in Convergence Insufficiency Group
14.1
SECONDARY
Mean Positive Fusional Vergence in Convergence Insufficiency Group
11.6
SECONDARY
Adult Strabismus 20 Questionnaire Score (DI)
62; 71; 87; 94
SECONDARY
Mean Convergence Insufficiency Symptom Survey Score
37.5
SECONDARY
Adult Strabismus 20 Questionnaire Score (CI)
55.7; 43.9; 92.2; 83.8

Summary

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.

Eligibility Criteria

Eligibility Criteria for Convergence Insufficiency (CI) Group:

The following inclusion 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 inclusion 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 inclusion 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 dista
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02510040). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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