Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06622044
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-28
Brief Title:
Vision Therapy Versus Prism Treatment in Small-angle Acute Acquired Concomitant Esotropia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Accommodation and Vergence Exercises Versus Prism Treatment for Small-angle Acute Acquired Concomitant Esotropia
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a single-center randomized controlled clinical trial to compare the effectiveness of vision therapy and prism wearing for the treatment of small-angle acute acquired concomitant esotropia
Detailed Description:
Acute acquired concomitant esotropia AACE belongs to the category of concomitant strabismus It is characterized by sudden onset often accompanied by diplopia and no change in the strabismus angle of each eye position In recent years with the increase in the use of smartphones and other screen devices the incidence of AACE has been on the rise Commonly used treatments in clinical practice include surgical treatment botulinum toxin injection into the medial rectus muscle and prism treatment Patients with large-angle esotropia generally require surgical intervention to fundamentally correct patients eye positions and eliminate diplopia However surgical treatment requires waiting for six months in order to performed after the strabismus degree is stable There are also risks of intraoperative trauma and secondary surgery Patients with early and small-angle esotropia often choose prism treatment
The principle of prism treatment is light refraction After light is refracted through a prism it falls on the fovea of the strabismic eye eliminating diplopia In the treatment of AACE the main target population of prisms is patients with mild strabismus the strabismus angle is usually less than 25 PD Wu et al 2022 Wearing prisms can eliminate diplopia and relieve related symptoms but it does not really correct the strabismus problem
The high incidence of AACE is related to excessive close work and use of electronic products Excessive close eye use can lead to accommodative dysfunction Studies have found that AACE patients have abnormal accommodative function Tong et al 2020 Herlihy et al 2013 Kemmanu et al 2012 Lee et al 2016 The accommodative function of AACE patients is weaker than normal and the accommodation convergence to accommodation ACA ratio is higher than normal Tong et al 2020 During clinical diagnosis and treatment the accommodative function of AACE patients was examined and it was found that there was indeed abnormal accommodative function Based on scientific research findings and the actual basis of clinical practice improving accommodative function through accommodative training may be a good treatment option for early and small-angle AACE patients However existing studies have not fully explored the effectiveness and safety of accommodative exercise in the treatment of small-angle AACE and there has been no study comparing the therapeutic outcomes of accommodative training and prism treatment on small-angle AACE
In order to better guide clinical practice we conducted a randomized controlled study to objectively evaluate and compare the therapeutic effects of accommodative training and prism therapy on AACE It is expected that the research results will provide more treatment options for AACE patients and provide important guidance for clinical selection of appropriate methods to treat small-angle AACE
The principle of prism treatment is light refraction After light is refracted through a prism it falls on the fovea of the strabismic eye eliminating diplopia In the treatment of AACE the main target population of prisms is patients with mild strabismus the strabismus angle is usually less than 25 PD Wu et al 2022 Wearing prisms can eliminate diplopia and relieve related symptoms but it does not really correct the strabismus problem
The high incidence of AACE is related to excessive close work and use of electronic products Excessive close eye use can lead to accommodative dysfunction Studies have found that AACE patients have abnormal accommodative function Tong et al 2020 Herlihy et al 2013 Kemmanu et al 2012 Lee et al 2016 The accommodative function of AACE patients is weaker than normal and the accommodation convergence to accommodation ACA ratio is higher than normal Tong et al 2020 During clinical diagnosis and treatment the accommodative function of AACE patients was examined and it was found that there was indeed abnormal accommodative function Based on scientific research findings and the actual basis of clinical practice improving accommodative function through accommodative training may be a good treatment option for early and small-angle AACE patients However existing studies have not fully explored the effectiveness and safety of accommodative exercise in the treatment of small-angle AACE and there has been no study comparing the therapeutic outcomes of accommodative training and prism treatment on small-angle AACE
In order to better guide clinical practice we conducted a randomized controlled study to objectively evaluate and compare the therapeutic effects of accommodative training and prism therapy on AACE It is expected that the research results will provide more treatment options for AACE patients and provide important guidance for clinical selection of appropriate methods to treat small-angle AACE
Study Oversight
Has Oversight DMC:
None
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?:
None