N/A
N=386
Trial of Overminus Spectacle Therapy for Intermittent Exotropia
Intermittent Exotropia
Bottom Line
View on ClinicalTrials.gov: NCT02807350 ↗Enrolled (actual)
386
Serious AEs
0.0%
Results posted
Jun 2022
Primary outcome: Primary: Mean Distance Control at 12-Months (On-Treatment Visit) — 1.8; 2.8 points
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
- Nov 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Distance Control at 12-Months (On-Treatment Visit) |
1.8; 2.8 | — |
| PRIMARY Mean Distance Control at 18-Months (Off-Treatment Visit) |
2.4; 2.7 | — |
| SECONDARY Number of Participants With No Spontaneous Tropia |
115; 62 | — |
| SECONDARY No Spontaneous Tropia |
85; 60 | — |
| SECONDARY Change in Distance Control |
86; 68; 48; 30 | — |
| SECONDARY Change in Distance Control |
86; 68; 48; 30 | — |
| SECONDARY Deterioration as Assessed by Motor Alignment and Stereoacuity at Near (12 Months) |
5; 7 | — |
| SECONDARY Deterioration as Assessed by Motor Alignment and Stereoacuity at Near (18 Months) |
6; 16 | — |
| SECONDARY Near Control (12 Months) |
96; 64; 59; 55; 21; 13 | — |
| SECONDARY Near Control (18 Months) |
72; 59; 60; 46; 16; 18 | — |
| SECONDARY Change in Near Control (12 Months) |
0.7; 0.1 | — |
| SECONDARY Change in Near Control (18 Months) |
0.4; 0.1 | — |
| SECONDARY Angle Magnitude (12 Months) |
20.0; 25.0 | — |
| SECONDARY Angle Magnitude (18 Months) |
23.0; 24.0 | — |
| SECONDARY Stereoacuity at 12 Months |
2.0; 2.0 | — |
| SECONDARY Stereoacuity at 18 Months |
1.9; 1.9 | — |
| SECONDARY Compliance With Spectacle Wear (12 Months) |
143; 128; 26; 28; 10; 8 | — |
| SECONDARY Compliance With Spectacle Wear (18 Months) |
128; 120; 23; 14; 8; 13 | — |
| SECONDARY Parent Symptom Survey [12 Months] |
1; 1; 74; 71; 58; 64 | — |
| SECONDARY Parent Symptom Survey [18 Months] |
0; 1; 76; 63; 49; 55 | — |
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).
Eligibility Criteria
Inclusion Criteria
- Age 3 years to 1500 grams
- Parent understands the protocol and is willing to accept randomization to overminus spectacles or non-overminus spectacles
- 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 18 months is not anticipated
Exclusion Criteria
- Treatment for IXT or amblyopia (other than refractive correction) within the past 4 weeks, including vision therapy, patching, atropine, or other penalization.
- Current contact lens wear
- Substantial deliberate overminus treatment within the past 6 months, defined as spectacles overminused by more than 1.00D SE than the cycloplegic refractive error (within 2 months or at the end of the enrollment exam)
- Prior strabismus, intraocular, or refractive surgery (including BOTOX injection)
- Abnormality of the cornea, lens, or central retina
- Down syndrome or cerebral palsy
- 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.
- Any disease known to affect accommodation, vergence, and ocular motility such as multiple sclerosis, Graves orbitopathy, dysautonomia, myasthenia gravis, or current use of atropine for amblyopia
- Anti-seizure medications [e.g., carbamazepine (Tegretol, Carbatrol, Epitol, or Equetro), diazepam (Valium or Diastat), clobazam (Frisium or Onfri), clonazepam (Klonopin), lorazepam (Ativan), ethosuximide (Zarontin), felbamate (Felbatol), lacosamide (VIMPAT), gabapentin (Neurontin), oxcarbazepine (Oxtellar XR or Trileptal), phenobarbital, phenytoin (Dilantin or Phenytek), pregabalin (Lyrica), tiagabine (Gabitril), topiramate (Topamax), valproate (Depakote), or zonisamide (Zonegran), vigabatrin (Sabril)]
Data sourced from ClinicalTrials.gov (NCT02807350). 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.