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Under-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
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Accommodative Esotropia focused on measuring accommodative esotropia

Eligibility Criteria

24 Months - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

First Posted
August 5, 2010
Last Updated
August 10, 2010
Sponsor
Samsung Medical Center
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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

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Under-correction in Refractive Accommodative Esotropia

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