A Prospective Observational Study of Adult Strabismus
Convergence Insufficiency · Divergence Insufficiency · Hypertropia
Bottom Line
View on ClinicalTrials.gov: NCT02510040 ↗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
| Outcome | Result | p-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
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
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.