A Prospective Observational Study of Adult Strabismus (NCT02510040) | Clinical Trial Compass
CompletedNot Applicable
A Prospective Observational Study of Adult Strabismus
United States217 participantsStarted 2015-08-17
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Eligibility Criteria for Convergence Insufficiency (CI) Group:
The following inclusion criteria must be met for the subject to be enrolled into the study:
* Adults ā„18 years of age (adult onset of CI not required)
* No strabismus surgery within the past 10 years
* CI Symptom Survey score ā„21 points
* Near exodeviation of ā„4ā and at least 4ā larger than at distance by PACT
* Distance exodeviation ā¤15ā by PACT
* Vertical deviation ā¤2ā at distance and near by PACT
* No constant exotropia at distance or near
* Reduced positive fusional vergence (PFV) at near (\<20ā or fails Sheard's criterion that the PFV measures less than twice the magnitude of the near phoria)
* Near point of convergence (NPC) of ā„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 wiā¦
What they're measuring
1
Number of Participants With Symptom Success at 10 Weeks
Timeframe: 10 weeks after enrollment
2
Number of Participants With Symptom Success at 12 Months