Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2026-03-17 @ 2:14 AM
Study NCT ID:
NCT02223650
Status:
COMPLETED
Last Update Posted:
2017-05-19
First Post:
2014-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Pilot Clinical Trial of Overminus Spectacle Therapy for Intermittent Exotropia
Sponsor:
Jaeb Center for Health Research
Organization:
Study Overview
Official Title:
A Pilot Randomized Clinical Trial of Overminus Spectacle Therapy for Intermittent Exotropia
Status:
COMPLETED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IXT3
Brief 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.
Detailed Description:
The objective of this short-term, pilot randomized trial comparing 2.50D overminus lens treatment vs. non-overminus (spectacles without overminus or no spectacles) 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 overminus by comparing treatment groups on the following outcomes:
* Mean distance IXT control score (each patient's score is the mean of 3 control scores) (primary outcome)
* The proportion of subjects with treatment response, defined as 1 or more points improvement in mean of 3 distance IXT control scores (secondary outcome)
* Adverse effects, near visual acuity outcomes, and spectacle wear compliance
* Mean distance IXT control score (each patient's score is the mean of 3 control scores) (primary outcome)
* The proportion of subjects with treatment response, defined as 1 or more points improvement in mean of 3 distance IXT control scores (secondary outcome)
* Adverse effects, near visual acuity outcomes, and spectacle wear compliance
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2U10EY011751 | NIH | None | https://reporter.nih.gov/quic… | View |