Trial of Overminus Spectacle Therapy for Intermittent Exotropia (NCT02807350) | Clinical Trial Compass
CompletedNot Applicable
Trial of Overminus Spectacle Therapy for Intermittent Exotropia
United States386 participantsStarted 2017-01-16
Plain-language summary
The main objectives of this randomized trial comparing overminus lens treatment to non-overminus (spectacles without overminus or spectacles with plano lenses) are to determine:
* The long-term on-treatment effect of overminus treatment on distance intermittent exotropia (IXT) control score.
* The off-treatment effect of overminus treatment on distance IXT control score (following weaning and 3 months off treatment).
Who can participate
Age range3 Years – 10 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.
Inclusion Criteria:
* Age 3 years to \< 11 years
* Intermittent exotropia (manifest deviation) meeting all of the following criteria:
* At distance: intermittent exotropia or constant exotropia
o Mean distance control score of 2 points or more (mean of 3 assessments over the exam)
* At near: intermittent exotropia, exophoria, or orthophoria
o Subject cannot have a score of 5 points on all 3 near assessments of control
* Exodeviation at least 15∆ at distance measured by PACT
* Near deviation does not exceed distance deviation by more than 10∆ by PACT (convergence insufficiency type IXT excluded)
* Distance visual acuity (any optotype method) in each eye of 0.4 logMAR (20/50) or better if age 3 years and 0.3 logMAR (20/40) or better if 4 years or older.
* Interocular difference of distance visual acuity ≤0.2 logMAR (2 lines on a logMAR chart)
* Refractive error between -6.00 diopters (D) standard error (SE) and +1.00D SE (inclusive) in the most myopic / least hyperopic eye based on a cycloplegic refraction performed within the past 2 months or at the end of the enrollment exam.
* If refractive error (based on cycloplegic refraction performed within past 2 months or at the end of the enrollment exam) meets any of the following criteria, then pre-study spectacles are required and must have been worn for at least 1 week prior to enrollment:
* SE anisometropia ≥1.00D
* Astigmatism ≥1.50D in either eye
* SE myopia ≥-1.00D in either eye
Pre-study refractive correction, if wor…
What they're measuring
1
Mean Distance Control at 12-Months (On-Treatment Visit)
Timeframe: 12 months
2
Mean Distance Control at 18-Months (Off-Treatment Visit)