N/A
N=58
A Pilot Clinical Trial of Overminus Spectacle Therapy for Intermittent Exotropia
Intermittent Exotropia
Bottom Line
View on ClinicalTrials.gov: NCT02223650 ↗Enrolled (actual)
58
Serious AEs
0.0%
Results posted
Dec 2016
Primary outcome: Primary: Mean Distance Exotropia Control Score — 2.0; 2.8 points on control score scale — p=0.01
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Overminus treatment (Device); Non-overminus treatment (Device)
- Age
- Pediatric · 3+ yrs
- Sex
- All
- Sponsor
- Jaeb Center for Health Research
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Distance Exotropia Control Score |
2.0; 2.8 | 0.01 sig |
| SECONDARY Mean Near Exotropia Control Score |
0.9; 1.2 | 0.14 |
| SECONDARY Distribution of Distance Control Score at 8-week Outcome |
4; 1; 11; 7; 5; 10 | — |
| SECONDARY Distribution of Near Control Score at 8-week Outcome |
15; 10; 7; 13; 2; 3 | — |
| SECONDARY Proportion of Subjects With Distance Control Treatment Response |
16; 12 | 0.07 |
| SECONDARY Symptom Survey Response to Question: Has Child Looked Over His/Her Spectacles Since Enrollment? |
0; 0; 3; 1; 7; 2 | — |
| SECONDARY Stereoacuity |
2.2; 2.2 | — |
| SECONDARY Distance Visual Acuity |
21.1; 23.0 | — |
| SECONDARY Binocular Near Visual Acuity |
12.8; 16.9 | — |
| SECONDARY Symptom Survey Response to Question: Has Your Child Had Eyestrain (Tired, Sore, or Uncomfortable Eyes)? |
0; 0; 0; 0; 4; 3 | — |
| SECONDARY Symptom Survey Response to Question: Since Enrollment Has Your Child Avoided Reading or Doing Things up Close? |
0; 0; 0; 0; 1; 1 | — |
| SECONDARY Symptom Survey Response to Question: Has Your Child Reported Blurry Vision? |
0; 0; 0; 0; 1; 1 | — |
| SECONDARY Proportion of Subjects With Near Control Treatment Response |
7; 8 | 0.54 |
Summary
The objective of this short-term, pilot randomized trial comparing 2.50 diopters (D) overminus lens treatment vs. non-overminus (spectacles without overminus or no spectacles) in children with intermittent exotropia (IXT) 3 to <7 years of age is to determine whether to proceed to a full-scale, longer-term randomized trial.
Eligibility Criteria
The following criteria must be met for the child to be enrolled in the study:
- Age 3 years to 1.00D.
- The SE of the spectacles must be within 1500 grams
- No Down syndrome or cerebral palsy
- No severe developmental delay which would interfere with treatment or evaluation (in the opinion of the investigator). Subjects with mild speech delays or reading and/or learning disabilities are not excluded.
- No disease known to affect accommodation, vergence, and ocular motility such as multiple sclerosis, Graves orbitopathy, myasthenia gravis, diabetes mellitus, or Parkinson disease
- No current use of any ocular or systemic medication known to affect accommodation or vergence, such as anti-anxiety agents (e.g., Librium or Valium), anti-arrhythmic agents (e.g., Cifenline, Cibenzoline), anti-cholinergics (e.g., motion sickness patch (scopolamine)), bladder spasmolytic drugs (e.g., Propiverine), hydroxychloroquine, chloroquine, phenothiazines (e.g., Compazine, Mellaril, Thorazine), tricyclic antidepressants (e.g., Elavil, Nortriptyline, Tofranil)
- Parent understands the protocol and is willing to accept randomization to overminus spectacles or non-overminus status
- Parent has home phone (or access to phone) and is willing to be contacted by Jaeb Center staff and Investigator's site staff
- Relocation outside of area of an active PEDIG site within next 8 weeks is not anticipated
Data sourced from ClinicalTrials.gov (NCT02223650). 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.