Ignite Creation Date:
2025-12-24 @ 5:19 PM
Ignite Modification Date:
2025-12-29 @ 1:13 PM
Study NCT ID:
NCT02807350
Status:
COMPLETED
Last Update Posted:
2022-06-03
First Post:
2016-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Trial of Overminus Spectacle Therapy for Intermittent Exotropia
Sponsor:
Jaeb Center for Health Research
Organization:
Study Overview
Official Title:
A Randomized Clinical Trial of Overminus Spectacle Therapy for Intermittent Exotropia
Status:
COMPLETED
Status Verified Date:
2022-05
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:
IXT5
Brief 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).
* 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).
Detailed Description:
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 IXT control score.
* The off-treatment effect of overminus treatment on distance IXT control score (following weaning and 3 months off treatment).
The recently completed IXT3 pilot study (NCT02223650) addressed the question of whether overminus lens therapy has an initial short-term therapeutic effect for IXT while wearing overminus spectacles. There have been no rigorous studies that address the following important questions related to overminus lens therapy:
* Does overminus lens therapy have a long-term therapeutic effect for IXT while wearing overminus spectacles (over many months or years)?
* Does overminus lens therapy have a long-term therapeutic effect for IXT when overminus spectacles are discontinued?
In November 2019, a protocol amendment discontinued overminus lens treatment and extended the study for an additional 18 months after the 18-month randomized trial has ended. The objective of the extension study is to compare long-term refractive error between subjects originally treated with either overminus spectacles or non-overminus spectacles as part of the 18-month randomized trial; treatment is at investigator discretion.
* The long-term on-treatment effect of overminus treatment on distance IXT control score.
* The off-treatment effect of overminus treatment on distance IXT control score (following weaning and 3 months off treatment).
The recently completed IXT3 pilot study (NCT02223650) addressed the question of whether overminus lens therapy has an initial short-term therapeutic effect for IXT while wearing overminus spectacles. There have been no rigorous studies that address the following important questions related to overminus lens therapy:
* Does overminus lens therapy have a long-term therapeutic effect for IXT while wearing overminus spectacles (over many months or years)?
* Does overminus lens therapy have a long-term therapeutic effect for IXT when overminus spectacles are discontinued?
In November 2019, a protocol amendment discontinued overminus lens treatment and extended the study for an additional 18 months after the 18-month randomized trial has ended. The objective of the extension study is to compare long-term refractive error between subjects originally treated with either overminus spectacles or non-overminus spectacles as part of the 18-month randomized trial; treatment is at investigator discretion.
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 |