A Prospective Observational Study of Adult Strabismus

NCT ID: NCT02510040

Last Updated: 2023-07-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 217 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-08-17
• Study Completion Date: 2019-01-31

Brief 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.

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.

Conditions

Convergence Insufficiency; Divergence Insufficiency; Hypertropia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Prism

Intervention Type: DEVICE

Ground-in or Fresnel prism

Orthoptic Exercises

Intervention Type: OTHER

Orthoptic exercises- fusion, convergence, divergence, and others, including computer-based therapy

Eye Muscle Surgery

Intervention Type: PROCEDURE

• 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

Botox Injection

Intervention Type: PROCEDURE

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.

Prism

Intervention Type: DEVICE

Ground-in or Fresnel prism

Orthoptic Exercises

Intervention Type: OTHER

Orthoptic exercises- fusion, convergence, divergence, and others, including computer-based therapy

Eye Muscle Surgery

Intervention Type: PROCEDURE

• 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

Botox Injection

Intervention Type: PROCEDURE

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.

Prism

Intervention Type: DEVICE

Ground-in or Fresnel prism

Orthoptic Exercises

Intervention Type: OTHER

Orthoptic exercises- fusion, convergence, divergence, and others, including computer-based therapy

Eye Muscle Surgery

Intervention Type: PROCEDURE

• 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

Botox Injection

Intervention Type: PROCEDURE

Botulinum toxin injection

Interventions

Prism

Ground-in or Fresnel prism

Intervention Type: DEVICE

Orthoptic Exercises

Orthoptic exercises- fusion, convergence, divergence, and others, including computer-based therapy

Intervention Type: OTHER

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

Intervention Type: PROCEDURE

Botox Injection

Botulinum toxin injection

Intervention Type: PROCEDURE

Other Intervention Names

Botulinum toxin injection

Eligibility Criteria

Inclusion Criteria

• 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:

• 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:

• 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

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

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pediatric Eye Disease Investigator Group

NETWORK

Sponsor Role: collaborator

National Eye Institute (NEI)

NIH

Sponsor Role: collaborator

Jaeb Center for Health Research

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Earl R Crouch, III, MD

Role: STUDY_CHAIR

Virginia Pediatric Eye Center

Locations

Earl R. Crouch, III

Norfolk, Virginia, United States

Countries

United States

References

Crouch ER, Dean TW, Kraker RT, Miller AM, Kraus CL, Gunton KB, Repka MX, Marsh JD, Del Monte MA, Luke PA, Peragallo JH, Lee KA, Wheeler MB, Daley TJ, Wallace DK, Cotter SA, Holmes JM; Pediatric Eye Disease Investigator Group. A prospective study of treatments for adult-onset divergence insufficiency-type esotropia. J AAPOS. 2021 Aug;25(4):203.e1-203.e11. doi: 10.1016/j.jaapos.2021.02.014. Epub 2021 Jul 13.

Reference Type: RESULT

PMID: 34271207 (View on PubMed)

Lorenzana IJ, Leske DA, Hatt SR, Dean TW, Jenewein EC, Dagi LR, Beal CJ, Pang Y, Retnasothie DV, Esposito CA, Erzurum SA, Aldrich AE, Crouch ER, Li Z, Kraker RT, Holmes JM, Cotter SA; Pediatric Eye Disease Investigator Group; Pediatric Eye Disease Investigator Group. Relationships among Clinical Factors and Patient-reported Outcome Measures in Adults with Convergence Insufficiency. Optom Vis Sci. 2022 Sep 1;99(9):692-701. doi: 10.1097/OPX.0000000000001929. Epub 2022 Aug 2.

Reference Type: RESULT

PMID: 35914096 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

http://pedig.jaeb.org

PEDIG Public Website

Other Identifiers

2U10EY011751

Identifier Type: NIH

Identifier Source: secondary_id

View Link

SAS1

Identifier Type: -

Identifier Source: org_study_id