Base-in Prism Spectacles for Intermittent Exotropia
Public ClinicalTrials.gov record NCT03998670. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Intermittent Exotropia Study 6: A Pilot Randomized Clinical Trial of Base-in Prism Spectacles for Intermittent Exotropia
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The objective of this short-term, pilot randomized trial comparing spectacles with relieving prism to spectacles without prism is to determine whether to proceed to a full-scale, longer-term randomized trial. This decision will be based primarily on assessing the initial (8-week) response to prism by comparing treatment groups on the following outcomes: * Mean distance intermittent exotropia (IXT) control score (the mean of 3 control scores) (primary outcome) * The proportion of participants demonstrating a "treatment response," defined as ≥1 point improvement in the mean distance IXT control score without spontaneous exotropia during control testing (secondary outcome) * The proportion of participants reporting adverse effects and good/excellent spectacle wear compliance
Study identification
- NCT ID
- NCT03998670
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 61 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 3 Years to 13 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 1, 2019 (Actual)
- Primary completion
- Jul 30, 2020 (Actual)
- Completion
- Jul 30, 2020 (Actual)
- Last update posted
- Oct 4, 2023
2019 – 2020
United States locations
- U.S. sites
- 28
- U.S. states
- 20
- U.S. cities
- 26
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UAB Pediatric Eye Care; Birmingham Health Care | Birmingham | Alabama | 35294 | — |
| Midwestern University Eye Institute | Glendale | Arizona | 85308 | — |
| Arkansas Childrens | Little Rock | Arkansas | 72202 | — |
| Southern California College of Optometry | Fullerton | California | 92831-1699 | — |
| Western University College of Optometry | Pomona | California | 91766 | — |
| Nova Southeastern University College of Optometry, The Eye Institute | Fort Lauderdale | Florida | 33382 | — |
| Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | — |
| Illinois College of Optometry | Chicago | Illinois | 60616 | — |
| University of Chicago | Hyde Park | Illinois | 60637 | — |
| Indiana School of Optometry | Bloomington | Indiana | 47405 | — |
| Indiana University School of Optometry | Indianapolis | Indiana | 47405 | — |
| Wolfe Eye Clinic | West Des Moines | Iowa | 50266 | — |
| University of Kentucky Department of Neurology | Lexington | Kentucky | 40536 | — |
| Wilmer Eye Institute | Baltimore | Maryland | 21287-9028 | — |
| Boston Medical Center | Boston | Massachusetts | 02118 | — |
| Boston Children's Hospital Waltham | Boston | Massachusetts | 02453 | — |
| Pediatric Ophthalmology, P.C. | Grand Rapids | Michigan | 49546 | — |
| University of Nebraska Medical Center | Omaha | Nebraska | 68114 | — |
| Cincinnati Children's Hospital | Cincinnati | Ohio | 45229 | — |
| Ohio State University College of Optometry | Columbus | Ohio | 43210-1280 | — |
| OHSU Casey Eye Institute | Portland | Oregon | 97239 | — |
| Pediatric Ophthalmology of Erie | Erie | Pennsylvania | 16501 | — |
| Salus University/Pennsylvania College of Optometry | Philadelphia | Pennsylvania | 19141 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| Texas Children's Hospital - Dept. Of Ophthalmology | Houston | Texas | 77030 | — |
| Houston Eye Associates | The Woodlands | Texas | 77381 | — |
| Virginia Pediatric Eye Center | Norfolk | Virginia | 23502 | — |
| Gundersen Health System | La Crosse | Wisconsin | 54601 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03998670, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 4, 2023 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03998670 live on ClinicalTrials.gov.