Back to resultsUnder-correction in Refractive Accommodative Esotropia
Primary Purpose
Accommodative Esotropia
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Glasses prescription
Sponsored by
About this trial
This is an interventional treatment trial for Accommodative Esotropia focused on measuring accommodative esotropia
Eligibility Criteria
Inclusion Criteria:
- patients with accommodative esotropia
- older than 24 months
Exclusion Criteria:
- unstable eye alignment
- older than 18 years
Sites / Locations
- Samsung Medical Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
glasses prescription
Arm Description
At initial visit(of study), the physician will reduce the diopter of hyperopic glasses as much as the patient can maintain their eye alignment (maximum amount 1.5D).
Outcomes
Primary Outcome Measures
eye alignment
Follow-up examinations are scheduled at 1 week, 1 month, 3 months, and 6 months after the patients begin wearing under-corrected spectacles. At every visit, symptoms such as asthenopia, diplopia, or blurred vision will be documented and ocular examinations including ocular alignment status for distance and near will be performed.
Secondary Outcome Measures
stereopsis
Follow-up examinations are scheduled at 1 week, 1 month, 3 months, and 6 months after the patients begin wearing under-corrected spectacles. At every visit, tests of fusion and stereoacuity will be performed.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01179711
Brief Title
Under-correction in Refractive Accommodative Esotropia
Official Title
The Maximal Tolerable Reduction in Hyperopic Correction in Patients With Refractive Accommodative Esotropia: A 6-month Follow-up Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Samsung Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
In most clinics, physicians reduce diopter of hyperopic glasses in older patients with accommodative esotropia. However, there are risks of decompensation in that practice. The authors are going to try measure the change of stability of eye alignment after reducing diopter of hyperopic glasses.
Detailed Description
Inclusion criteria :
patients with accommodative esotropia
At initial visit(of study), the physician will reduce the diopter of hyperopic glasses as much as the patient can maintain their eye alignment (maximum amount 1.5D).
Outcome measure :
Follow-up examinations are scheduled at 1 week, 1 month, 3 months, and 6 months after the patients begin wearing under-corrected spectacles. At every visit, symptoms such as asthenopia, diplopia, or blurred vision will be documented and ocular examinations, including visual acuity and ocular alignment status for distance and near will be performed. Tests of fusion and stereoacuity will be performed at the 1-month, 3-month, and 6-month follow-up visits.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Accommodative Esotropia
Keywords
accommodative esotropia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
glasses prescription
Arm Type
Other
Arm Description
At initial visit(of study), the physician will reduce the diopter of hyperopic glasses as much as the patient can maintain their eye alignment (maximum amount 1.5D).
Intervention Type
Device
Intervention Name(s)
Glasses prescription
Intervention Description
At initial visit(of study), the physician will reduce the diopter of hyperopic glasses as much as the patient can maintain their eye alignment (maximum amount 1.5D).
Primary Outcome Measure Information:
Title
eye alignment
Description
Follow-up examinations are scheduled at 1 week, 1 month, 3 months, and 6 months after the patients begin wearing under-corrected spectacles. At every visit, symptoms such as asthenopia, diplopia, or blurred vision will be documented and ocular examinations including ocular alignment status for distance and near will be performed.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
stereopsis
Description
Follow-up examinations are scheduled at 1 week, 1 month, 3 months, and 6 months after the patients begin wearing under-corrected spectacles. At every visit, tests of fusion and stereoacuity will be performed.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
24 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
patients with accommodative esotropia
older than 24 months
Exclusion Criteria:
unstable eye alignment
older than 18 years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sei Yeul Oh, MD
Organizational Affiliation
Samsung Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
21236414
Citation
Park KA, Kim SM, Oh SY. The maximal tolerable reduction in hyperopic correction in patients with refractive accommodative esotropia: a 6-month follow-up study. Am J Ophthalmol. 2011 Mar;151(3):535-41.e2. doi: 10.1016/j.ajo.2010.09.023. Epub 2011 Jan 13.
Results Reference
derived
Learn more about this trial
Under-correction in Refractive Accommodative Esotropia
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