A Prospective Observational Study of Adult Strabismus (SAS1)

Jaeb Center for Health Research

Status: Completed

Conditions: Divergence Insufficiency; Hypertropia; Convergence Insufficiency

Treatments: Procedure: Botox Injection; Procedure: Eye Muscle Surgery; Other: Orthoptic Exercises; Device: Prism

Study type: Observational

Funder types: Other; NETWORK; NIH

Identifiers

NCT02510040

SAS1

2U10EY011751 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 217 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 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

Exclusion Criteria for Convergence Insufficiency (CI) Group:

The following criteria exclude a subject from enrollment into the study:

• 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
• Constant exotropia at distance or near
• Near point of convergence (NPC) of ≤6 cm break
• Visual acuity worse than 20/50 either eye by ETDRS or Snellen
• Paralytic strabismus (e.g., 3rd, 4th, or 6th cranial nerve palsies, skew deviation, Duane syndrome)
• Restrictive strabismus (e.g., blowout fracture, thyroid eye disease, post scleral buckle, Brown syndrome)
• Monocular diplopia
• 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.
• Inferior or superior oblique overaction defined as 2+ or greater
• Inability to fuse with prism in space (see section 2.4.1)
• Inability to understand and complete a survey
• Treatment to be initiated has already been used within the past one year

Exclusion Criteria for Divergence Insufficiency (DI) Group:

The following criteria exclude a subject from enrollment into the study:

• No adult-onset DI (at ≥18 years of age)
• Prior strabismus surgery
• Distance esodeviation outside the range of 2∆ to 30∆ and less than 50% larger than at near by PACT
• More than 5∆ difference between right and left gaze by PACT
• More than 10∆ difference between the primary position at distance
• Any coexisting vertical deviation more than distance esodeviation and ≥10∆ by PACT
• Visual acuity worse than 20/50 in either eye by ETDRS or Snellen
• Paralytic strabismus (e.g., 3rd, 4th, or 6th cranial nerve palsies, skew deviation, Duane syndrome)
• Restrictive strabismus (e.g., blowout fracture, thyroid eye disease, post scleral buckle, Brown syndrome)
• Monocular diplopia
• Paretic strabismus, thyroid eye disease, myasthenia gravis, chronic progressive external ophthalmoplegia, or eye movement abnormalities associated with known neurological disease.
• Inferior or superior oblique overaction defined as 2+ or greater
• Inability to fuse with prism in space (see section 2.4.2)
• Inability to understand and complete a survey
• Treatment to be initiated has already been used within the past one year

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

The following criteria exclude a subject from enrollment into the study:

• No adult-onset HT (at ≥18 years of age)
• Prior strabismus surgery
• Vertical deviation ≤1∆ or ≥10∆ at distance and near by PACT
• More than 4∆ difference from the primary in any gaze position by PACT
• Coexisting esodeviation must not be less than the vertical deviation
• Coexisting exodeviation ≥10∆ by PACT
• Convergence insufficiency as defined in section 2.2.1
• Visual acuity worse than 20/50 in either eye by ETDRS or Snellen
• Paralytic strabismus (e.g., 3rd, 4th, or 6th cranial nerve palsies, skew deviation, Duane syndrome)
• Restrictive strabismus (e.g., blowout fracture, thyroid eye disease, post scleral buckle, Brown syndrome)
• Monocular diplopia
• Paretic strabismus, thyroid eye disease, myasthenia gravis, chronic progressive external ophthalmoplegia, or eye movement abnormalities associated with known neurological disease.
• Inferior or superior oblique overaction defined as 2+ or greater
• Inability to fuse with prism in space (see section 2.4.3)
• Inability to understand and complete a survey
• Treatment to be initiated has already been used within the past one year

Trial design

217 participants in 3 patient groups

Convergence insufficiency

Description:

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.

Treatment:

Device: Prism

Other: Orthoptic Exercises

Procedure: Eye Muscle Surgery

Procedure: Botox Injection

Divergence insufficiency

Description:

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.

Treatment:

Device: Prism

Other: Orthoptic Exercises

Procedure: Eye Muscle Surgery

Procedure: Botox Injection

Small-angle hypertropia

Description:

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.

Treatment:

Device: Prism

Other: Orthoptic Exercises

Procedure: Eye Muscle Surgery

Procedure: Botox Injection