Norfolk, Virginia 23502


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.


Study 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. Treatment comparisons within the studied conditions will also be done to help develop future studies.


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


NCT ID:

NCT02510040


Primary Contact:

Study Chair
Earl R Crouch, III, MD
Virginia Pediatric Eye Center

Raymond Kraker, MSPH
Phone: 813-975-8690
Email: rkraker@jaeb.org


Backup Contact:

Email: pedig@jaeb.org
Jennifer Shah
Phone: 8139758690


Location Contact:

Norfolk, Virginia 23502
United States

Earl R. Crouch, III, M.D.
Phone: 757-461-0050

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 23, 2017

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