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NCT03998670 · ClinicalTrials.gov registry record · NA
Base-in Prism Spectacles for Intermittent Exotropia
A NA study, sponsored by Jaeb Center for Health Research.
- Completed
- Registry status
- NA
- Development phase
- 61
- Enrollment target
NCT03998670: Completed NA study, sponsored by Jaeb Center for Health Research.
NCT03998670 is a NA study that has completed, run by Jaeb Center for Health Research. The registered enrollment target is 61 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03998670, a NA study, has completed, sponsored by Jaeb Center for Health Research.
- COMPLETED
- Registry status
- NA
- Development phase
- 61 participants
- Enrollment target
Study Summary
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
Primary Outcome
The primary analysis will be an intent-to-treat comparison of mean 8-week control of the distance exodeviation (average of 3 measurements) between treatment groups using an analysis of covariance (ANCOVA) model, which adjusts for baseline distance control. Distance control scores range from 0 to 5 with higher scores indicating a worse outcome.
Interventions
- DEVICE Prism Glasses
- DEVICE Non-Prism Glasses
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2019-09-01 |
| Est. Completion | 2020-07-30 |
| Phase | NA |
What the finished NCT03998670 record still lists
NCT03998670 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Prism Glasses is the first listed.
NCT03998670 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03998670 about?
NCT03998670 is a clinical study titled "Base-in Prism Spectacles for Intermittent Exotropia". 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 b...
What is the current status of trial NCT03998670?
This trial is currently completed. It is a NA study. The enrollment target is 61 participants. The study started on 2019-09-01. Estimated completion is 2020-07-30.
What interventions are being tested in trial NCT03998670?
The interventions under investigation include: Prism Glasses (DEVICE), Non-Prism Glasses (DEVICE).
Who is sponsoring clinical trial NCT03998670?
This trial is sponsored by Jaeb Center for Health Research, which has 119 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03998670's enrollment target sits among peer trials
61 1164th of 2000 higher than 837 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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