Under-correction in Refractive Accommodative Esotropia

• Sponsor: Samsung Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01179711
• Collaborator: (none)
• Enrollment: 41
• Location: 1
• Arm: 1
• Duration (Months): 11
• Patients Per Site Per Month: 3.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Accommodative Esotropia	Device: Glasses prescription	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 41 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Maximal Tolerable Reduction in Hyperopic Correction in Patients With Refractive Accommodative Esotropia: A 6-month Follow-up Study
• Study Start Date: Jun 1, 2009
• Actual Primary Completion Date: May 1, 2010
• Actual Study Completion Date: May 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Other: 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).	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).

Outcome Measures

Primary Outcome Measures

1. eye alignment [6 months]

   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

1. stereopsis [6 months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 24 Months to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• patients with accommodative esotropia

• older than 24 months

Exclusion Criteria:

• unstable eye alignment

• older than 18 years

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center	Seoul		Korea, Republic of

Sponsors and Collaborators

• Samsung Medical Center

Investigators

• Study Chair: Sei Yeul Oh, MD, Samsung Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01179711
• Other Study ID Numbers: 2009-06-027
• First Posted: Aug 11, 2010
• Last Update Posted: Aug 11, 2010
• Last Verified: Aug 1, 2010

• Keywords provided by , ,: accommodative esotropia
• Additional relevant MeSH terms: Esotropia; Strabismus

Study Results

No Results Posted as of Aug 11, 2010