Under-correction in Refractive Accommodative Esotropia

Accommodative Esotropia Clinical Trial

Official title:

The Maximal Tolerable Reduction in Hyperopic Correction in Patients With Refractive Accommodative Esotropia: A 6-month Follow-up Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01179711
• Other study ID #: 2009-06-027
• Status: Completed
• Phase: N/A
• First received: August 5, 2010
• Last updated: August 10, 2010
• Start date: June 2009
• Est. completion date: May 2010

Study information

• Verified date: August 2010
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 24 Months to 18 Years

Eligibility

Inclusion Criteria:

• patients with accommodative esotropia

• older than 24 months

Exclusion Criteria:

• unstable eye alignment

• older than 18 years

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Accommodative Esotropia
• Esotropia
• Strabismus

Intervention

Device:
• Glasses prescription
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).

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months	No
Secondary	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.	6 months	No